--- title: "Is It Approved? Peptide Regulatory Status: PH, US, EU" url: https://www.primaralabs.com/research/status source: Primara Labs, markdown mirror of the HTML page --- # Approved where, and for what. As of 3 November 2026, this tracker records the status of each compound in the Primara Labs catalogue with FDA Philippines, the US Food and Drug Administration and the European Medicines Agency, each read from the authority's own database or the sponsor's own statement. An approval applies to a named medicine for a named indication; it never makes a vial sold for research use an approved product. Primara Labs sells some of the compounds covered here. Every figure on this page links to its source and the date it was checked. Updated 3 November 2026 GLP-1s Explained: How They Work, Simply (Philippines Guide)1:45·[Transcript and chapters](https://www.primaralabs.com/videos/glp1s-explained) All compounds ## Status by authority FDA PhilippinesUS FDAEMA17 of 17 rows *Regulatory status by compound* | Compound | FDA Philippines | US FDA | EMA | Sponsor's next milestone | | --- | --- | --- | --- | --- | | Retatrutide | Not established | Investigational | No record found | Sponsor plans a US Biologics License Application submission in Q1 2027 | | Tirzepatide | Not established | Approved for glycemic control in type 2 diabetes mellitus (Mounjaro); weight reduction in obesity or overweight with a comorbidity and moderate to severe obstructive sleep apnea in adults with obesity (Zepbound) | Approved for type 2 diabetes mellitus and weight management (Mounjaro) | None published | | Semaglutide | Not established | Approved for glycemic control in type 2 diabetes mellitus and related cardiovascular and kidney risk reduction (Ozempic, Rybelsus); chronic weight management and cardiovascular risk reduction in obesity or overweight (Wegovy) | Approved for type 2 diabetes mellitus (Ozempic, Rybelsus), weight management (Wegovy) and non-cirrhotic MASH with F2 to F3 fibrosis (Kayshild) | None published | | BPC-157 | Not established | No record found | No record found | None published | | TB-500 (thymosin beta-4) | Not established | No record found | No record found | None published | | GHK-Cu (copper tripeptide-1) | Not established | No record found | No record found | None published | | KPV | Not established | No record found | No record found | None published | | NAD+ (nicotinamide adenine dinucleotide) | Not established | No record found | No record found | None published | | MOTS-c | Not established | No record found | No record found | None published | | Elamipretide (SS-31) | Not established | Approved under accelerated approval for Barth syndrome in patients weighing at least 30 kg | Not established | A confirmatory randomised, placebo-controlled trial in Barth syndrome, required by FDA as a condition of the accelerated approval | | Tesamorelin | Not established | Approved for reduction of excess abdominal fat in HIV-infected adult patients with lipodystrophy | Not approved | None published | | CJC-1295 | Not established | No record found | No record found | None published | | Ipamorelin | Not established | No record found | No record found | None published | | Bremelanotide (PT-141) | Not established | Approved for acquired, generalized hypoactive sexual desire disorder (HSDD) in premenopausal women | No record found | None published | | Semax | Not established | No record found | No record found | None published | | Selank | Not established | No record found | No record found | None published | | DSIP (delta sleep-inducing peptide) | Not established | No record found | No record found | None published | [Download JSON](https://www.primaralabs.com/data/regulatory.json)[Download CSV](https://www.primaralabs.com/data/regulatory.csv) Metabolic ## Is Retatrutide approved in the Philippines? Retatrutide: FDA Philippines status not established (Could not be established: the FDA Philippines verification portal search timed out on 23 September 2026, retried the same day in a browser with the same result.); US FDA "Investigational". Checked 23 September 2026. FDA Philippines Not established Could not be established: the FDA Philippines verification portal search timed out on 23 September 2026, retried the same day in a browser with the same result. Not published US FDA Investigational Eli Lilly's release of 23 July 2026 describes retatrutide as investigational. Drugs@FDA returned no approved application. [Source](https://lilly.mediaroom.com/2026-07-23-Lillys-triple-agonist,-retatrutide,-successful-in-two-additional-Phase-3-obesity-trials,-delivering-significant-improvements-in-weight-and-A1C) · checked 23 September 2026 EMA No record found No row for this substance in the EMA medicines report generated 22 September 2026. That report does not cover national authorisations in EU member states. [Source](https://www.ema.europa.eu/en/documents/report/medicines-output-medicines-report_en.xlsx) · checked 23 September 2026 Sponsor's next milestone Sponsor plans a US Biologics License Application submission in Q1 2027 Eli Lilly press release dated 23 July 2026. [Source](https://lilly.mediaroom.com/2026-07-23-Lillys-triple-agonist,-retatrutide,-successful-in-two-additional-Phase-3-obesity-trials,-delivering-significant-improvements-in-weight-and-A1C) · checked 23 September 2026 - [Evidence Map: Retatrutide](https://www.primaralabs.com/research/evidence#retatrutide) - [Retatrutide 20mg](https://www.primaralabs.com/marketplace/retatrutide) Metabolic ## Is Tirzepatide approved in the Philippines? Tirzepatide: FDA Philippines status not established (Could not be established: the FDA Philippines verification portal search timed out on 23 September 2026, retried the same day in a browser with the same result.); US FDA "Approved for glycemic control in type 2 diabetes mellitus (Mounjaro); weight reduction in obesity or overweight with a comorbidity and moderate to severe obstructive sleep apnea in adults with obesity (Zepbound)". Checked 23 September 2026. FDA Philippines Not established Could not be established: the FDA Philippines verification portal search timed out on 23 September 2026, retried the same day in a browser with the same result. Not published US FDA Approved for glycemic control in type 2 diabetes mellitus (Mounjaro); weight reduction in obesity or overweight with a comorbidity and moderate to severe obstructive sleep apnea in adults with obesity (Zepbound) Drugs@FDA: Mounjaro (NDA215866, approved 13 May 2022); Zepbound (NDA217806, approved 8 November 2023). The approval covers the named branded medicine for its labelled use only, never a vial of the same substance sold for research use. [Source](https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=215866) · checked 23 September 2026 EMA Approved for type 2 diabetes mellitus and weight management (Mounjaro) Mounjaro, EMEA/H/C/005620, authorised 15 September 2022. The authorisation covers the named medicine only. [Source](https://www.ema.europa.eu/en/medicines/human/EPAR/mounjaro) · checked 23 September 2026 Sponsor's next milestone Not established None sought: an approved medicine already exists. Not published - [Evidence Map: Tirzepatide](https://www.primaralabs.com/research/evidence#tirzepatide) - [Tirzepatide 15mg](https://www.primaralabs.com/marketplace/tirzepatide-15mg) Metabolic ## Is Semaglutide approved in the Philippines? Semaglutide: FDA Philippines status not established (Could not be established: the FDA Philippines verification portal search timed out on 23 September 2026, retried the same day in a browser with the same result.); US FDA "Approved for glycemic control in type 2 diabetes mellitus and related cardiovascular and kidney risk reduction (Ozempic, Rybelsus); chronic weight management and cardiovascular risk reduction in obesity or overweight (Wegovy)". Checked 23 September 2026. FDA Philippines Not established Could not be established: the FDA Philippines verification portal search timed out on 23 September 2026, retried the same day in a browser with the same result. Not published US FDA Approved for glycemic control in type 2 diabetes mellitus and related cardiovascular and kidney risk reduction (Ozempic, Rybelsus); chronic weight management and cardiovascular risk reduction in obesity or overweight (Wegovy) Drugs@FDA: Ozempic (NDA209637, approved 5 December 2017); WEGOVY (injection) (NDA215256, approved 4 June 2021); RYBELSUS / OZEMPIC (tablets) (NDA213051, approved 20 September 2019); Rybelsus (NDA213182, approved 16 January 2020); WEGOVY (tablets) (NDA218316, approved 22 December 2025). The approval covers the named branded medicine for its labelled use only, never a vial of the same substance sold for research use. [Source](https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=209637) · checked 23 September 2026 EMA Approved for type 2 diabetes mellitus (Ozempic, Rybelsus), weight management (Wegovy) and non-cirrhotic MASH with F2 to F3 fibrosis (Kayshild) Five authorised products containing semaglutide, all held by Novo Nordisk A/S. The authorisation covers the named medicines only. [Source](https://www.ema.europa.eu/en/medicines/human/EPAR/ozempic) · checked 23 September 2026 Sponsor's next milestone Not established None sought: an approved medicine already exists. Not published - [Evidence Map: Semaglutide](https://www.primaralabs.com/research/evidence#semaglutide) - [Semaglutide 15mg](https://www.primaralabs.com/marketplace/semaglutide-15mg) Tissue repair ## Is BPC-157 approved in the Philippines? BPC-157: FDA Philippines status not established (Could not be established: the FDA Philippines verification portal search timed out on 23 September 2026, retried the same day in a browser with the same result.); US FDA "No record found". Checked 23 September 2026. FDA Philippines Not established Could not be established: the FDA Philippines verification portal search timed out on 23 September 2026, retried the same day in a browser with the same result. Not published US FDA No record found Drugs@FDA returned no approved or tentatively approved application for this substance. Drugs@FDA does not list investigational products. Separately, the FDA lists it on its page of bulk drug substances for compounding that may present significant safety risks (current as of 22 April 2026); that page concerns compounding, not approval. [Source](https://api.fda.gov/drug/drugsfda.json?search=openfda.generic_name:%22BPC-157%22&limit=10) · checked 23 September 2026 EMA No record found No row for this substance in the EMA medicines report generated 22 September 2026. That report does not cover national authorisations in EU member states. [Source](https://www.ema.europa.eu/en/documents/report/medicines-output-medicines-report_en.xlsx) · checked 23 September 2026 Sponsor's next milestone Not established No sponsor identified in any record read. Not published - [Evidence Map: BPC-157](https://www.primaralabs.com/research/evidence#bpc-157) - [BPC-157 20mg](https://www.primaralabs.com/marketplace/bpc-157-20mg) - [Wolverine Blend 20mg](https://www.primaralabs.com/marketplace/wolverine-blend) - [GLOW Blend 70mg](https://www.primaralabs.com/marketplace/glow-blend-70mg) - [KLOW Blend 80mg](https://www.primaralabs.com/marketplace/klow-blend-80mg) Tissue repair ## Is TB-500 approved in the Philippines? TB-500: FDA Philippines status not established (Could not be established: the FDA Philippines verification portal search timed out on 23 September 2026, retried the same day in a browser with the same result.); US FDA "No record found". Checked 23 September 2026. FDA Philippines Not established Could not be established: the FDA Philippines verification portal search timed out on 23 September 2026, retried the same day in a browser with the same result. Not published US FDA No record found Drugs@FDA returned no approved or tentatively approved application for this substance. Drugs@FDA does not list investigational products. Separately, the FDA lists it on its page of bulk drug substances for compounding that may present significant safety risks (current as of 22 April 2026); that page concerns compounding, not approval. [Source](https://api.fda.gov/drug/drugsfda.json?search=openfda.generic_name:%22thymosin%20beta-4%22&limit=10) · checked 23 September 2026 EMA No record found No row for this substance in the EMA medicines report generated 22 September 2026. That report does not cover national authorisations in EU member states. [Source](https://www.ema.europa.eu/en/documents/report/medicines-output-medicines-report_en.xlsx) · checked 23 September 2026 Sponsor's next milestone Not established No sponsor identified in any record read. Not published - [Evidence Map: TB-500](https://www.primaralabs.com/research/evidence#tb-500) - [Wolverine Blend 20mg](https://www.primaralabs.com/marketplace/wolverine-blend) - [GLOW Blend 70mg](https://www.primaralabs.com/marketplace/glow-blend-70mg) - [KLOW Blend 80mg](https://www.primaralabs.com/marketplace/klow-blend-80mg) Tissue repair ## Is GHK-Cu approved in the Philippines? GHK-Cu: FDA Philippines status not established (Could not be established: the FDA Philippines verification portal search timed out on 23 September 2026, retried the same day in a browser with the same result.); US FDA "No record found". Checked 23 September 2026. FDA Philippines Not established Could not be established: the FDA Philippines verification portal search timed out on 23 September 2026, retried the same day in a browser with the same result. Not published US FDA No record found Drugs@FDA returned no approved or tentatively approved application for this substance. Drugs@FDA does not list investigational products. Separately, the FDA lists it on its page of bulk drug substances for compounding that may present significant safety risks (current as of 22 April 2026); that page concerns compounding, not approval. [Source](https://api.fda.gov/drug/drugsfda.json?search=openfda.generic_name:%22GHK-Cu%22&limit=10) · checked 23 September 2026 EMA No record found No row for this substance in the EMA medicines report generated 22 September 2026. That report does not cover national authorisations in EU member states. [Source](https://www.ema.europa.eu/en/documents/report/medicines-output-medicines-report_en.xlsx) · checked 23 September 2026 Sponsor's next milestone Not established No sponsor identified in any record read. Not published - [Evidence Map: GHK-Cu](https://www.primaralabs.com/research/evidence#ghk-cu) - [GHK-Cu 50mg](https://www.primaralabs.com/marketplace/ghk-cu-50mg) - [GLOW Blend 70mg](https://www.primaralabs.com/marketplace/glow-blend-70mg) - [KLOW Blend 80mg](https://www.primaralabs.com/marketplace/klow-blend-80mg) Tissue repair ## Is KPV approved in the Philippines? KPV: FDA Philippines status not established (Could not be established: the FDA Philippines verification portal search timed out on 23 September 2026, retried the same day in a browser with the same result.); US FDA "No record found". Checked 23 September 2026. FDA Philippines Not established Could not be established: the FDA Philippines verification portal search timed out on 23 September 2026, retried the same day in a browser with the same result. Not published US FDA No record found Drugs@FDA returned no approved or tentatively approved application for this substance. Drugs@FDA does not list investigational products. Separately, the FDA lists it on its page of bulk drug substances for compounding that may present significant safety risks (current as of 22 April 2026); that page concerns compounding, not approval. [Source](https://api.fda.gov/drug/drugsfda.json?search=openfda.generic_name:%22KPV%22&limit=10) · checked 23 September 2026 EMA No record found No row for this substance in the EMA medicines report generated 22 September 2026. That report does not cover national authorisations in EU member states. [Source](https://www.ema.europa.eu/en/documents/report/medicines-output-medicines-report_en.xlsx) · checked 23 September 2026 Sponsor's next milestone Not established No sponsor identified in any record read. Not published - [Evidence Map: KPV](https://www.primaralabs.com/research/evidence#kpv) - [KLOW Blend 80mg](https://www.primaralabs.com/marketplace/klow-blend-80mg) Cellular ## Is NAD+ approved in the Philippines? NAD+: FDA Philippines status not established (Could not be established: the FDA Philippines verification portal search timed out on 23 September 2026, retried the same day in a browser with the same result.); US FDA "No record found". Checked 23 September 2026. FDA Philippines Not established Could not be established: the FDA Philippines verification portal search timed out on 23 September 2026, retried the same day in a browser with the same result. Not published US FDA No record found Drugs@FDA returned no approved or tentatively approved application for this substance. Drugs@FDA does not list investigational products. [Source](https://api.fda.gov/drug/drugsfda.json?search=openfda.generic_name:%22NAD%22&limit=10) · checked 23 September 2026 EMA No record found No row for this substance in the EMA medicines report generated 22 September 2026. That report does not cover national authorisations in EU member states. [Source](https://www.ema.europa.eu/en/documents/report/medicines-output-medicines-report_en.xlsx) · checked 23 September 2026 Sponsor's next milestone Not established No sponsor identified in any record read. Not published - [Evidence Map: NAD+](https://www.primaralabs.com/research/evidence#nad) - [NAD+ 1000mg](https://www.primaralabs.com/marketplace/nad-1000mg) Cellular ## Is MOTS-c approved in the Philippines? MOTS-c: FDA Philippines status not established (Could not be established: the FDA Philippines verification portal search timed out on 23 September 2026, retried the same day in a browser with the same result.); US FDA "No record found". Checked 23 September 2026. FDA Philippines Not established Could not be established: the FDA Philippines verification portal search timed out on 23 September 2026, retried the same day in a browser with the same result. Not published US FDA No record found Drugs@FDA returned no approved or tentatively approved application for this substance. Drugs@FDA does not list investigational products. Separately, the FDA lists it on its page of bulk drug substances for compounding that may present significant safety risks (current as of 22 April 2026); that page concerns compounding, not approval. [Source](https://api.fda.gov/drug/drugsfda.json?search=openfda.generic_name:%22MOTS-c%22&limit=10) · checked 23 September 2026 EMA No record found No row for this substance in the EMA medicines report generated 22 September 2026. That report does not cover national authorisations in EU member states. [Source](https://www.ema.europa.eu/en/documents/report/medicines-output-medicines-report_en.xlsx) · checked 23 September 2026 Sponsor's next milestone Not established No sponsor identified in any record read. Not published - [Evidence Map: MOTS-c](https://www.primaralabs.com/research/evidence#mots-c) - [MOTS-c 10mg](https://www.primaralabs.com/marketplace/mots-c-10mg) Cellular ## Is Elamipretide approved in the Philippines? Elamipretide: FDA Philippines status not established (Not established: the FDA Philippines verification portal was not reachable when this SKU was added on 3 November 2026.); US FDA "Approved under accelerated approval for Barth syndrome in patients weighing at least 30 kg". Checked 3 November 2026. FDA Philippines Not established Not established: the FDA Philippines verification portal was not reachable when this SKU was added on 3 November 2026. Not published US FDA Approved under accelerated approval for Barth syndrome in patients weighing at least 30 kg FDA press announcement, September 2025. The accelerated approval rests on knee extensor muscle strength in TAZPOWER, and FDA requires a confirmatory randomised, placebo-controlled trial. It covers the approved prescription medicine for its labelled use only, never a vial of the same substance sold for research use. [Source](https://www.fda.gov/news-events/press-announcements/fda-grants-accelerated-approval-first-treatment-barth-syndrome) · checked 3 November 2026 EMA Not established Not checked: the EMA medicines report was not read for this compound on 3 November 2026. Not published Sponsor's next milestone A confirmatory randomised, placebo-controlled trial in Barth syndrome, required by FDA as a condition of the accelerated approval FDA press announcement, September 2025. [Source](https://www.fda.gov/news-events/press-announcements/fda-grants-accelerated-approval-first-treatment-barth-syndrome) · checked 3 November 2026 - [Evidence Map: Elamipretide](https://www.primaralabs.com/research/evidence#elamipretide) - [SS-31 10mg](https://www.primaralabs.com/marketplace/ss-31) Growth hormone axis ## Is Tesamorelin approved in the Philippines? Tesamorelin: FDA Philippines status not established (Could not be established: the FDA Philippines verification portal search timed out on 23 September 2026, retried the same day in a browser with the same result.); US FDA "Approved for reduction of excess abdominal fat in HIV-infected adult patients with lipodystrophy". Checked 23 September 2026. FDA Philippines Not established Could not be established: the FDA Philippines verification portal search timed out on 23 September 2026, retried the same day in a browser with the same result. Not published US FDA Approved for reduction of excess abdominal fat in HIV-infected adult patients with lipodystrophy Drugs@FDA: Egrifta (BLA022505, approved 10 November 2010). The approval covers the named branded medicine for its labelled use only, never a vial of the same substance sold for research use. [Source](https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=022505) · checked 23 September 2026 EMA Not approved The application for Egrifta (EMEA/H/C/002427) was withdrawn on 21 June 2012; no marketing authorisation was granted. [Source](https://www.ema.europa.eu/en/medicines/human/EPAR/egrifta) · checked 23 September 2026 Sponsor's next milestone Not established None sought: an approved medicine already exists. Not published - [Evidence Map: Tesamorelin](https://www.primaralabs.com/research/evidence#tesamorelin) - [Tesamorelin 10mg](https://www.primaralabs.com/marketplace/tesamorelin-10mg) Growth hormone axis ## Is CJC-1295 approved in the Philippines? CJC-1295: FDA Philippines status not established (Could not be established: the FDA Philippines verification portal search timed out on 23 September 2026, retried the same day in a browser with the same result.); US FDA "No record found". Checked 23 September 2026. FDA Philippines Not established Could not be established: the FDA Philippines verification portal search timed out on 23 September 2026, retried the same day in a browser with the same result. Not published US FDA No record found Drugs@FDA returned no approved or tentatively approved application for this substance. Drugs@FDA does not list investigational products. Separately, the FDA lists it on its page of bulk drug substances for compounding that may present significant safety risks (current as of 22 April 2026); that page concerns compounding, not approval. [Source](https://api.fda.gov/drug/drugsfda.json?search=openfda.generic_name:%22CJC-1295%22&limit=10) · checked 23 September 2026 EMA No record found No row for this substance in the EMA medicines report generated 22 September 2026. That report does not cover national authorisations in EU member states. [Source](https://www.ema.europa.eu/en/documents/report/medicines-output-medicines-report_en.xlsx) · checked 23 September 2026 Sponsor's next milestone Not established No sponsor identified in any record read. Not published - [Evidence Map: CJC-1295](https://www.primaralabs.com/research/evidence#cjc-1295) - [CJC-1295 / Ipamorelin 5mg + 5mg](https://www.primaralabs.com/marketplace/cjc-1295-ipamorelin-10mg) Growth hormone axis ## Is Ipamorelin approved in the Philippines? Ipamorelin: FDA Philippines status not established (Could not be established: the FDA Philippines verification portal search timed out on 23 September 2026, retried the same day in a browser with the same result.); US FDA "No record found". Checked 23 September 2026. FDA Philippines Not established Could not be established: the FDA Philippines verification portal search timed out on 23 September 2026, retried the same day in a browser with the same result. Not published US FDA No record found Drugs@FDA returned no approved or tentatively approved application for this substance. Drugs@FDA does not list investigational products. Separately, the FDA lists it on its page of bulk drug substances for compounding that may present significant safety risks (current as of 22 April 2026); that page concerns compounding, not approval. [Source](https://api.fda.gov/drug/drugsfda.json?search=openfda.generic_name:%22ipamorelin%22&limit=10) · checked 23 September 2026 EMA No record found No row for this substance in the EMA medicines report generated 22 September 2026. That report does not cover national authorisations in EU member states. [Source](https://www.ema.europa.eu/en/documents/report/medicines-output-medicines-report_en.xlsx) · checked 23 September 2026 Sponsor's next milestone Not established No sponsor identified in any record read. Not published - [Evidence Map: Ipamorelin](https://www.primaralabs.com/research/evidence#ipamorelin) - [CJC-1295 / Ipamorelin 5mg + 5mg](https://www.primaralabs.com/marketplace/cjc-1295-ipamorelin-10mg) Melanocortin ## Is Bremelanotide approved in the Philippines? Bremelanotide: FDA Philippines status not established (Could not be established: the FDA Philippines verification portal search timed out on 23 September 2026, retried the same day in a browser with the same result.); US FDA "Approved for acquired, generalized hypoactive sexual desire disorder (HSDD) in premenopausal women". Checked 23 September 2026. FDA Philippines Not established Could not be established: the FDA Philippines verification portal search timed out on 23 September 2026, retried the same day in a browser with the same result. Not published US FDA Approved for acquired, generalized hypoactive sexual desire disorder (HSDD) in premenopausal women Drugs@FDA: Vyleesi (NDA210557, approved 21 June 2019). The approval covers the named branded medicine for its labelled use only, never a vial of the same substance sold for research use. [Source](https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=210557) · checked 23 September 2026 EMA No record found No row for this substance in the EMA medicines report generated 22 September 2026. That report does not cover national authorisations in EU member states. [Source](https://www.ema.europa.eu/en/documents/report/medicines-output-medicines-report_en.xlsx) · checked 23 September 2026 Sponsor's next milestone Not established None sought: an approved medicine already exists. Not published - [Evidence Map: Bremelanotide](https://www.primaralabs.com/research/evidence#bremelanotide) - [PT-141 10mg](https://www.primaralabs.com/marketplace/pt-141-10mg) Neuropeptide ## Is Semax approved in the Philippines? Semax: FDA Philippines status not established (Could not be established: the FDA Philippines verification portal search timed out on 23 September 2026, retried the same day in a browser with the same result.); US FDA "No record found". Checked 23 September 2026. FDA Philippines Not established Could not be established: the FDA Philippines verification portal search timed out on 23 September 2026, retried the same day in a browser with the same result. Not published US FDA No record found Drugs@FDA returned no approved or tentatively approved application for this substance. Drugs@FDA does not list investigational products. Separately, the FDA lists it on its page of bulk drug substances for compounding that may present significant safety risks (current as of 22 April 2026); that page concerns compounding, not approval. [Source](https://api.fda.gov/drug/drugsfda.json?search=openfda.generic_name:%22semax%22&limit=10) · checked 23 September 2026 EMA No record found No row for this substance in the EMA medicines report generated 22 September 2026. That report does not cover national authorisations in EU member states. [Source](https://www.ema.europa.eu/en/documents/report/medicines-output-medicines-report_en.xlsx) · checked 23 September 2026 Sponsor's next milestone Not established No sponsor identified in any record read. Not published - [Evidence Map: Semax](https://www.primaralabs.com/research/evidence#semax) - [Semax 10mg](https://www.primaralabs.com/marketplace/semax-10mg) Neuropeptide ## Is Selank approved in the Philippines? Selank: FDA Philippines status not established (Could not be established: the FDA Philippines verification portal search timed out on 23 September 2026, retried the same day in a browser with the same result.); US FDA "No record found". Checked 23 September 2026. FDA Philippines Not established Could not be established: the FDA Philippines verification portal search timed out on 23 September 2026, retried the same day in a browser with the same result. Not published US FDA No record found Drugs@FDA returned no approved or tentatively approved application for this substance. Drugs@FDA does not list investigational products. Separately, the FDA lists it on its page of bulk drug substances for compounding that may present significant safety risks (current as of 22 April 2026); that page concerns compounding, not approval. [Source](https://api.fda.gov/drug/drugsfda.json?search=openfda.generic_name:%22selank%22&limit=10) · checked 23 September 2026 EMA No record found No row for this substance in the EMA medicines report generated 22 September 2026. That report does not cover national authorisations in EU member states. [Source](https://www.ema.europa.eu/en/documents/report/medicines-output-medicines-report_en.xlsx) · checked 23 September 2026 Sponsor's next milestone Not established No sponsor identified in any record read. Not published - [Evidence Map: Selank](https://www.primaralabs.com/research/evidence#selank) - [Selank 10mg](https://www.primaralabs.com/marketplace/selank-10mg) Neuropeptide ## Is DSIP approved in the Philippines? DSIP: FDA Philippines status not established (Could not be established: the FDA Philippines verification portal search timed out on 23 September 2026, retried the same day in a browser with the same result.); US FDA "No record found". Checked 23 September 2026. FDA Philippines Not established Could not be established: the FDA Philippines verification portal search timed out on 23 September 2026, retried the same day in a browser with the same result. Not published US FDA No record found Drugs@FDA returned no approved or tentatively approved application for this substance. Drugs@FDA does not list investigational products. Separately, the FDA lists it on its page of bulk drug substances for compounding that may present significant safety risks (current as of 22 April 2026); that page concerns compounding, not approval. [Source](https://api.fda.gov/drug/drugsfda.json?search=openfda.generic_name:%22delta%20sleep-inducing%20peptide%22&limit=10) · checked 23 September 2026 EMA No record found No row for this substance in the EMA medicines report generated 22 September 2026. That report does not cover national authorisations in EU member states. [Source](https://www.ema.europa.eu/en/documents/report/medicines-output-medicines-report_en.xlsx) · checked 23 September 2026 Sponsor's next milestone Not established No sponsor identified in any record read. Not published - [Evidence Map: DSIP](https://www.primaralabs.com/research/evidence#dsip) - [DSIP 10mg](https://www.primaralabs.com/marketplace/dsip-10mg) FDA Philippines ## Advisories naming these compounds | Advisory | Date | Compounds | Summary | | --- | --- | --- | --- | | [FDA Advisory No. 2026-1020](https://www.fda.gov.ph/fda-advisory-no-2026-1020-public-health-warning-against-the-purchase-and-use-of-the-unregistered-drug-product-tirzepatide-subcutaneously-use-only-30mg-multi-use-vial-and-bac-water-0-9-benz/) | 2026-09-04 | Tirzepatide | FDA Philippines warned the public against buying or using an unregistered tirzepatide 30mg multi-use vial sold with bacteriostatic water, which had not been issued a Certificate of Product Registration. | | [FDA Advisory No. 2026-1013](https://www.fda.gov.ph/fda-advisory-no-2026-1013-public-health-warning-against-the-purchase-and-use-of-the-unregistered-drug-product-kpv-subcutaneous-use-only-10mg-1ml-multi-use-vial-and-bacteriostatic-water-ste/) | 2026-09-04 | KPV | FDA Philippines warned the public against buying or using an unregistered KPV 10mg/1ml multi-use vial sold with bacteriostatic water, which had not been issued a Certificate of Product Registration. | | [FDA Advisory No. 2026-1019](https://www.fda.gov.ph/fda-advisory-no-2026-1019-public-health-warning-against-the-purchase-and-use-of-the-unregistered-drug-product-peptatide-tirzepatide-for-subcutaneously-use-only-15mg-and-peptatide-bacterios/) | 2026-09-04 | Tirzepatide | FDA Philippines warned the public against buying or using an unregistered tirzepatide product sold as Peptatide Tirzepatide 15mg with a bacteriostatic water kit, which had not been issued a Certificate of Product Registration. | | [FDA Advisory No. 2026-0814](https://www.fda.gov.ph/fda-advisory-no-2026-0814-public-health-warning-against-the-purchase-and-use-of-the-unregistered-drug-product-tirz-laine-tirzepatide-30mg-3-ml-99-purity/) | 2026-07-30 | Tirzepatide | FDA Philippines warned the public against buying or using an unregistered tirzepatide product sold as Tirz Laine Tirzepatide 30mg/3 mL, which had not been issued a Certificate of Product Registration. | | [FDA Advisory No. 2026-0596](https://www.fda.gov.ph/fda-advisory-no-2026-0596-endorsement-of-updates-on-the-list-of-vat-exempt-drugs-and-medicines/) | 2026-05-04 | Tirzepatide | FDA Philippines published updates to its list of VAT-exempt drugs and medicines under the CREATE Act, listing tirzepatide solutions for subcutaneous injection under medicines for diabetes. | | [FDA Advisory No. 2026-0065](https://www.fda.gov.ph/fda-advisory-no-2026-0065-endorsement-of-updates-on-the-list-of-vat-exempt-health-products/) | 2026-02-06 | Tirzepatide | FDA Philippines published updates to its list of VAT-exempt health products under the CREATE Act, listing tirzepatide solutions for subcutaneous injection among drugs for diabetes. | | [FDA Advisory No. 2025-1200](https://www.fda.gov.ph/fda-advisory-no-2025-1200-endorsement-of-updates-on-the-list-of-vat-exempt-health-products/) | 2025-11-06 | Semaglutide | FDA Philippines published updates to its list of VAT-exempt health products under the CREATE Act, including seven semaglutide solutions for injection listed under drugs for diabetes. | | [FDA Advisory No. 2025-0084](https://www.fda.gov.ph/fda-advisory-no-2025-0084-public-health-warning-against-the-purchase-and-consumption-of-the-unregistered-food-supplement-fulimiks-liposomal-nad-dietary-supplement-120-capsules/) | 2025-01-30 | NAD+ | FDA Philippines warned the public against buying or consuming an unregistered liposomal NAD+ food supplement in capsules, for which no Certificate of Product Registration had been issued. | [Download JSON](https://www.primaralabs.com/data/fda-ph-advisories.json)[Download CSV](https://www.primaralabs.com/data/fda-ph-advisories.csv) Method ## How statuses are recorded Methodology Values are exactly one of "Not approved", "Approved for" a named indication, "Investigational" or "No record found". "No record found" means the authority's database was searched and returned nothing; a status that could not be read is shown as "Not established" with the reason. US FDA statuses come from Drugs@FDA and the FDA label; EMA statuses from the EMA medicines data; FDA Philippines from its own registration records and advisories. Cite this Primara Labs Research Desk, "Regulatory status of peptides", last updated 3 November 2026, https://www.primaralabs.com/research/status