18+ · Research use only

18+ · Research Use Only · Not for Human Consumption

Regulatory Status Tracker

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)1:45Transcript and chapters

All compounds

Status by authority

FDA PhilippinesUS FDAEMA17 of 17 rows

Regulatory status by compound

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

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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 · 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 · 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 · checked 23 September 2026

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 · 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 · checked 23 September 2026
Sponsor's next milestone: Not established; None sought: an approved medicine already exists.; Not published

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 · 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 · checked 23 September 2026
Sponsor's next milestone: Not established; None sought: an approved medicine already exists.; Not published

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 · 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 · checked 23 September 2026
Sponsor's next milestone: Not established; No sponsor identified in any record read.; Not published

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 · 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 · checked 23 September 2026
Sponsor's next milestone: Not established; No sponsor identified in any record read.; Not published

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 · 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 · checked 23 September 2026
Sponsor's next milestone: Not established; No sponsor identified in any record read.; Not published

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 · 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 · checked 23 September 2026
Sponsor's next milestone: Not established; No sponsor identified in any record read.; Not published

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 · 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 · checked 23 September 2026
Sponsor's next milestone: Not established; No sponsor identified in any record read.; Not published

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 · 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 · checked 23 September 2026
Sponsor's next milestone: Not established; No sponsor identified in any record read.; Not published

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 · 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 · checked 3 November 2026

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 · 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 · checked 23 September 2026
Sponsor's next milestone: Not established; None sought: an approved medicine already exists.; Not published

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 · 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 · checked 23 September 2026
Sponsor's next milestone: Not established; No sponsor identified in any record read.; Not published

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 · 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 · checked 23 September 2026
Sponsor's next milestone: Not established; No sponsor identified in any record read.; Not published

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 · 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 · checked 23 September 2026
Sponsor's next milestone: Not established; None sought: an approved medicine already exists.; Not published

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 · 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 · checked 23 September 2026
Sponsor's next milestone: Not established; No sponsor identified in any record read.; Not published

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 · 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 · checked 23 September 2026
Sponsor's next milestone: Not established; No sponsor identified in any record read.; Not published

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 · 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 · checked 23 September 2026
Sponsor's next milestone: Not established; No sponsor identified in any record read.; Not published

FDA Philippines

Advisories naming these compounds

Advisory	Date	Compounds	Summary
FDA Advisory No. 2026-1020	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	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	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	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	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	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	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	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.

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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