FDA Peptide Status Tracker

Regulatory status for 80 tracked compounds. Updated April 2026.

April 15, 2026 — Major Regulatory Shift

12 peptides exited Category 2 on April 22. They are not yet authorized for compounding — awaiting PCAC advisory meetings in July 2026 and February 2027. Full explainer →

PCAC Countdown

Today: Saturday, May 9, 2026

April 22, 2026Completed

Category 2 Removal Effective

12 peptides officially exit the FDA 503A Category 2 restricted list. Compounds enter regulatory gray zone until PCAC acts.

BPC-157TB-500SemaxEpitalonMOTS-cKPVEmideltideGHK-CuMelanotan IILL-37DihexaPEG-MGF

June 30, 202652 days (7w)

Oral Presentation Request Deadline

Last day to request an oral presentation slot at the July 23-24 PCAC meeting.

July 9, 202661 days (~2mo)

Public Comment Deadline

Written comments for docket FDA-2025-N-6895 must be submitted by this date to be provided to the PCAC committee.

July 23, 202675 days (~2mo)

PCAC Day 1

Pharmacy Compounding Advisory Committee reviews Group 1 compounds for potential addition to the 503A bulk drug substances list.

BPC-157KPVMOTS-cTB-500

July 24, 202676 days (~2mo)

PCAC Day 2

PCAC continues with remaining Group 1 compounds.

EmideltideEpitalonSemax

February 28, 2027295 days (~9mo)

PCAC Group 2 (by Feb 2027)

Second round of PCAC review for remaining compounds removed from Category 2. Exact date TBD.

GHK-CuMelanotan IILL-37DihexaPEG-MGF

You Can Participate

PCAC meetings are public. Written comments by July 9 go directly to the committee. Oral presentation requests due June 30.

Public Docket FDA-2025-N-6895

Understanding the Status Tiers

What each tier means for patient access. Learn about 503A vs 503B pharmacies →

FDA ApprovedFDA Approved

Completed clinical trials and FDA approval process.

Category 1Category 1 — Compoundable

On the 503A bulks list. Compoundable with a physician prescription.

Pending PCACPending PCAC Review

Removed from Category 2. Awaiting PCAC advisory vote. Gray zone.

InvestigationalInvestigational

Active clinical trials. Not available through compounding.

UnregulatedUnregulated

No FDA category. Available only as research chemical or OTC supplement.

All Tracked Compounds

80 compounds

Compound	Category	Status	PCAC Date	Notes
Semaglutide	GLP-1 Agonist	FDA Approved	—	FDA-approved as Ozempic (diabetes, 2017), Wegovy (weight management, 2021), and Rybelsus (…
Tirzepatide	GLP-1/GIP Dual Agonist	FDA Approved	—	FDA-approved as Mounjaro (diabetes, 2022) and Zepbound (weight management, 2023).…
PT-141	Melanocortin & Sexual Health	FDA Approved	—	FDA-approved as Vyleesi (bremelanotide injection) in June 2019 for hypoactive sexual desir…
Tesamorelin	Growth Hormone Secretagogue	FDA Approved	—	FDA-approved as Egrifta (tesamorelin for injection) in 2010 for reduction of excess abdomi…
Liraglutide	GLP-1 Agonist	FDA Approved	—	FDA-approved as Victoza (type 2 diabetes, 2010) and Saxenda (weight management, 2014). The…
Oxytocin	Neurological & Hormonal	FDA Approved	—	FDA-approved as Pitocin for obstetric use (labor induction, postpartum hemorrhage). Intran…
Gonadorelin	Hormonal & Reproductive	FDA Approved	—	FDA-approved as Factrel for diagnostic evaluation of pituitary gonadotroph function. Lutre…
Setmelanotide	Metabolic	FDA Approved	—	FDA-approved as Imcivree (2020) for chronic weight management in patients 6+ years with ob…
Desmopressin	Hormonal & Renal	FDA Approved	—	FDA-approved in multiple formulations: DDAVP (nasal spray, injection, tablets), Stimate (n…
Leuprolide	GnRH Agonist	FDA Approved	—	FDA-approved as Lupron/Lupron Depot (multiple indications since 1985) and Eligard. One of …
Octreotide	Somatostatin Analog	FDA Approved	—	FDA-approved as Sandostatin (1988, subcutaneous) and Sandostatin LAR (1998, monthly depot)…
Lanreotide	Somatostatin Analog	FDA Approved	—	FDA-approved as Somatuline Depot (2007) for acromegaly and GEP-NETs. Administered as a dee…
Bivalirudin	Anticoagulant	FDA Approved	—	FDA-approved as Angiomax (2000) for use as an anticoagulant in patients undergoing PCI, in…
Teriparatide	Bone & Metabolic	FDA Approved	—	FDA-approved as Forteo (2002) for osteoporosis in postmenopausal women and men at high fra…
Zilucoplan	Immune & Neurological	FDA Approved	—	FDA-approved as Zilbrysq (2023) for generalized myasthenia gravis in adults who are anti-a…
Lixisenatide	GLP-1 Agonist	FDA Approved	—	FDA-approved as Adlyxin (2016) for type 2 diabetes. Also available as Soliqua 100/33 (fixe…
Exenatide	GLP-1 Agonist	FDA Approved	—	FDA-approved as Byetta (2005, twice daily) and Bydureon (2012, once weekly). The first-in-…
Dulaglutide	GLP-1 Agonist	FDA Approved	—	FDA-approved as Trulicity (2014) for type 2 diabetes and cardiovascular risk reduction (RE…
Abaloparatide	Bone & Metabolic	FDA Approved	—	FDA-approved as Tymlos (2017) for treatment of postmenopausal women with osteoporosis at h…
Calcitonin	Bone & Metabolic	FDA Approved	—	FDA-approved as Miacalcin (injection, 1986; nasal spray, 1995) and Fortical (nasal spray).…
Pramlintide	Metabolic	FDA Approved	—	FDA-approved as Symlin (2005) for type 1 and type 2 diabetes as an adjunct to mealtime ins…
CJC-1295	Growth Hormone Secretagogue	Category 1	—	Reclassified to Category 1 in February 2026 as part of the HHS announcement restoring comp…
AOD-9604	Metabolic	Category 1	—	Reclassified to Category 1 in February 2026 as part of the HHS announcement restoring comp…
Thymosin Alpha-1	Immune Support	Category 1	—	Reclassified to Category 1 in February 2026 as part of the HHS announcement restoring comp…
Ipamorelin	Growth Hormone Secretagogue	Category 1	—	Reclassified to Category 1 in February 2026 as part of the HHS announcement restoring comp…
Sermorelin	Growth Hormone Secretagogue	Category 1	—	Previously FDA-approved as Geref for diagnostic use and pediatric GH deficiency (withdrawn…
Hexarelin	Growth Hormone Secretagogue	Category 1	—	Reclassified to Category 1 in February 2026 as part of the HHS announcement restoring comp…
GHRP-6	Growth Hormone Secretagogue	Category 1	—	Reclassified to Category 1 in February 2026 as part of the HHS announcement restoring comp…
BPC-157	Healing & Recovery	Pending PCAC	July 23, 2026	On April 15, 2026, the FDA announced BPC-157 will be removed from the Category 2 'signific…
TB-500	Healing & Recovery	Pending PCAC	July 23, 2026	On April 15, 2026, the FDA announced TB-500 will be removed from the Category 2 'significa…
GHK-Cu	Anti-Aging & Skin	Pending PCAC	By February 2027	GHK-Cu has a notably complex status after the April 15, 2026 FDA announcement. Injectable …
Semax	Nootropic & Neuroprotective	Pending PCAC	July 24, 2026	Removed from FDA 503A Category 2 effective April 22, 2026. Scheduled for PCAC review on Ju…
Epitalon	Anti-Aging & Longevity	Pending PCAC	July 24, 2026	Removed from FDA 503A Category 2 effective April 22, 2026. Scheduled for PCAC review on Ju…
MOTS-c	Metabolic & Longevity	Pending PCAC	July 23, 2026	Removed from FDA 503A Category 2 effective April 22, 2026. Scheduled for PCAC review on Ju…
KPV	Anti-Inflammatory & Healing	Pending PCAC	July 23, 2026	Removed from FDA 503A Category 2 effective April 22, 2026. Scheduled for PCAC review on Ju…
Emideltide	Sleep & Neurological	Pending PCAC	July 24, 2026	Removed from FDA 503A Category 2 effective April 22, 2026. Scheduled for PCAC review on Ju…
Melanotan II	Melanocortin & Sexual Health	Pending PCAC	By February 2027	Removed from FDA 503A Category 2 effective April 22, 2026. Scheduled for PCAC review befor…
BPC-157 (Oral Form)	Healing & Recovery	Pending PCAC	July 23, 2026	Shares the same regulatory status as injectable BPC-157 — removed from FDA 503A Category 2…
BPC-157 Arginate (Stable Form)	Healing & Recovery	Pending PCAC	July 23, 2026	Same regulatory status as BPC-157. Removed from Category 2 on April 15, 2026. Scheduled fo…
Pentadecapeptide BPC (Stable Oral)	Healing & Recovery	Pending PCAC	2026-07-23	Shares regulatory status with BPC-157. Removed from Category 2 on April 22, 2026. Awaiting…
PEG-MGF	Growth & Recovery	Pending PCAC	2027-02-01	Removed from Category 2 on April 22, 2026. Scheduled for PCAC Group 2 review (by February …
Epithalon (Injectable Form)	Anti-Aging & Longevity	Pending PCAC	2026-07-24	Shares regulatory status with Epitalon. Removed from Category 2 on April 22, 2026. Schedul…
Retatrutide	GLP-1/GIP/Glucagon Triple Agonist	Investigational	—	Currently in Phase 3 clinical trials. Phase 2 results showed up to 24% body weight loss at…
SS-31	Mitochondrial & Cardioprotective	Investigational	—	Currently in clinical trials for heart failure with preserved ejection fraction (HFpEF) an…
Orforglipron	GLP-1 Agonist	Investigational	—	Currently in Phase 3 clinical trials for obesity and type 2 diabetes. Phase 2 results show…
Cagrilintide	Metabolic & Weight Management	Investigational	—	Currently in Phase 3 trials as CagriSema (cagrilintide 2.4 mg + semaglutide 2.4 mg). Phase…
Survodutide	Metabolic & Weight Management	Investigational	—	Currently in Phase 3 trials for obesity (SYNCHRONIZE program) and MASH (LIVERAGE program).…
Pemvidutide	Metabolic & Weight Management	Investigational	—	Phase 2 completed (MOMENTUM trial). Phase 2b for MASH (IMPACT trial) ongoing. Altimmune re…
Mazdutide	Metabolic & Weight Management	Investigational	—	Approved in China (late 2025) for obesity. Not yet submitted to FDA. Global Phase 3 trials…
VIP	Immune & Respiratory	Investigational	—	Aviptadil (synthetic VIP) has been studied in clinical trials for ARDS and pulmonary hyper…
Kisspeptin	Hormonal & Reproductive	Investigational	—	Not FDA-approved. Active clinical trials at Imperial College London and other institutions…
Enclomiphene	Hormonal & Reproductive	Investigational	—	Not FDA-approved. Repros Therapeutics (now Allergan) submitted NDA for Androxal but receiv…
Tesofensine	Metabolic	Investigational	—	Phase 3 clinical trials ongoing. Phase 2 showed up to 12.8% body weight loss at 24 weeks. …
Selank	Nootropic & Neuroprotective	Unregulated	—	Not FDA-approved and not currently on any FDA compounding list. Available as a research ch…
NAD+	Metabolic & Longevity	Unregulated	—	NAD+ itself is not FDA-approved as a drug. Injectable NAD+ is available through compoundin…
IGF-1 LR3	Growth & Anabolic	Unregulated	—	Not FDA-approved and not on any compounding list. Available as a research chemical. One of…
Follistatin 344	Growth & Anabolic	Unregulated	—	Not FDA-approved and not on any compounding list. Available as a research chemical. Myosta…
Pinealon	Nootropic & Neuroprotective	Unregulated	—	Not FDA-approved and not on any compounding list. Available as a research chemical. Resear…
Humanin	Mitochondrial & Longevity	Unregulated	—	Not FDA-approved and not on any compounding list. Available as a research chemical. One of…
5-Amino-1MQ	Metabolic & Weight Management	Unregulated	—	Not FDA-approved and not on any compounding list. Available as a research chemical. Growin…
Cerebrolysin	Nootropic & Neuroprotective	Unregulated	—	Not FDA-approved in the United States. Approved as a prescription drug in 50+ countries in…
GHRP-2	Growth Hormone Secretagogue	Unregulated	—	Not FDA-approved. Available as a research chemical. Pralmorelin (the INN name) has been st…
Dihexa	Nootropic & Cognitive	Unregulated	—	No FDA status. Purely a research compound with preclinical data only. No IND application o…
LL-37	Immune & Antimicrobial	Unregulated	—	Not FDA-approved as a therapeutic. LL-37 is an endogenous human peptide being studied in c…
SNAP-8	Cosmetic & Skin	Unregulated	—	Not FDA-regulated as a drug. Classified as a cosmetic ingredient. Widely used in over-the-…
Thymalin	Immune & Longevity	Unregulated	—	Not FDA-approved or recognized. Used clinically in Russia and some CIS countries. No FDA c…
Palmitoyl Pentapeptide-4	Cosmetic & Skin	Unregulated	—	Not regulated as a drug by the FDA. Classified as a cosmetic ingredient. No prescription r…
Acetyl Hexapeptide-8	Cosmetic & Skin	Unregulated	—	Not regulated as a drug by the FDA. Classified as a cosmetic ingredient. Available over-th…
Amlexanox	Metabolic	Unregulated	—	Previously FDA-approved as Aphthasol (topical paste for canker sores) but voluntarily with…
Thymosin Alpha-1 + Thymalin Protocol	Immune Support	Unregulated	—	Thymosin Alpha-1 is FDA-approved internationally (Zadaxin) but not in the US. Thymalin has…
DSIP	Sleep & Recovery	Unregulated	—	No FDA regulatory category. Available only as a research chemical. Not approved for any cl…
Thymosin Beta-4	Healing & Recovery	Unregulated	—	No FDA regulatory category for the full-length peptide. TB-500 (the fragment) is pending P…
Collagen Peptides	Structural & Skin	Unregulated	—	Classified as a dietary supplement under DSHEA. Not FDA-approved for any medical indicatio…
Glutathione	Antioxidant & Detox	Unregulated	—	Available as a dietary supplement (oral) and through IV clinics. Not FDA-approved for any …
MGF	Growth & Recovery	Unregulated	—	No FDA regulatory category. Available only as a research chemical. Not approved for any cl…
AHK-Cu	Anti-Aging & Skin	Unregulated	—	No FDA regulatory category. Available as a research chemical and in some cosmetic formulat…
Lactoferrin	Immune & Antimicrobial	Unregulated	—	Available as a dietary supplement (GRAS status). Not FDA-approved for any medical indicati…
Noopept	Nootropic & Neuroprotective	Unregulated	—	No FDA regulatory category. Available as a research chemical in the US. Approved as a pres…
Palmitoyl Tripeptide-1	Cosmetic & Skin	Unregulated	—	Cosmetic ingredient. Not FDA-regulated as a drug. Widely available in skincare products wi…
Human Beta-Defensin 2	Immune & Antimicrobial	Unregulated	—	No FDA regulatory category. Available only as a research reagent. No clinical trials for t…

Showing 80 of 80 compounds

Regulatory Timeline

April 15–22, 2026guidance

Mainstream Media Coverage Wave — WaPo, Forbes, CNBC

Major outlets published extensive coverage of the FDA peptide policy shift, marking the transition from niche health news to mainstream coverage.

April 15, 2026reclassificationBreaking

FDA Removes 12 Peptides from Category 2 — PCAC Meetings Scheduled

12 peptides exit Category 2 effective April 22. PCAC meetings scheduled for July 23–24, 2026 and before February 2027. Removal does NOT authorize compounding — compounds enter a regulatory gray zone until PCAC acts.

BPC-157TB-500SemaxEpitalonMOTS-cKPVEmideltideGHK-CuMelanotan IILL-37DihexaPEG-MGF

Source

February 27, 2026reclassification

HHS Secretary Announces Category 1 Restorations

~14 peptides moved back to Category 1, restoring compounding access. Includes Thymosin Alpha-1, Sermorelin, Ipamorelin, CJC-1295, and AOD-9604.

Thymosin Alpha-1SermorelinIpamorelinCJC-1295AOD-9604

September 2023restriction

FDA Places 19 Peptides on Category 2 Restricted List

19 widely used peptides moved to Category 2 'significant safety risks,' barring compounding pharmacies from preparing them.

December 2023approval

Zepbound (Tirzepatide) Approved for Weight Management

FDA approved tirzepatide (Zepbound) for chronic weight management.

Tirzepatide

June 2021approval

Wegovy (Semaglutide) Approved for Weight Management

FDA approved semaglutide 2.4mg (Wegovy) for chronic weight management.

Semaglutide

This tracker is for educational and informational purposes only. Regulatory status changes rapidly — always verify current status with a licensed healthcare provider or legal counsel before making clinical or business decisions.