Not medical advice. Talk to your provider before using any peptide.
Full disclaimerPeptide Regulatory Tracker: FDA Status and Compounding Lists
This tracker shows where 25 peptides stand with the FDA. It covers every peptide on this site with a dated FDA status record: approvals, withdrawals, label changes, clinical development and compounding list positions, each checked against FDA and ClinicalTrials.gov records. Each row gives the US status, the approved products behind it, and the peptide's position on FDA's compounding lists, dated to the FDA document it comes from. It also lists all 35 FDA-approved peptides on this site, plus 3 whose approval FDA withdrew, with the FDA applications behind them.
Peptide Schedule Research TeamReviewed Oct 10, 2026
At a Glance
Browse all approved peptides by goal, with what the research and users say about each, in the FDA-approved peptides explorer.
Are Peptides Legal in the US?
It depends on the peptide and how it is sold. 35 peptides on this site have at least one FDA approval, and 33 still have a product a doctor can prescribe, listed with prescription status in FDA's records, such as semaglutide and tirzepatide. The full list is below. At each maker's request, FDA has withdrawn the approvals of enfuvirtide (Fuzeon), nesiritide (Natrecor) and sermorelin (Geref).
Under section 503A, a pharmacy can compound from a bulk substance only if one of three things is true. It has a USP or NF monograph, it is part of an FDA-approved drug, or it is on FDA's 503A bulks list. Substances nominated for that list sit in interim categories while FDA reviews them. FDA's interim policy says it does not intend to act against pharmacies using Category 1 substances, if other conditions are met. Category 2 holds substances FDA says raise significant safety risks, and the policy does not cover them. Outsourcing facilities under 503B follow a separate list.
Peptides sold "for research use only" are not approved for use in people. This section covers FDA status only. State laws and other countries differ, and it is not legal advice.
12 Peptides Left Category 2 in April 2026
FDA's 503A categories list, current as of , shows the nominations for 12 peptides as withdrawn by their nominators: BPC-157, TB-500, Epithalon, GHK-Cu, MOTS-c, Melanotan II, KPV, LL-37, Semax, DSIP, Dihexa and PEG-MGF. They were in Category 2, the group FDA says raises significant safety risks. Leaving Category 2 does not put a peptide on the 503A bulks list or make it eligible for compounding. That takes FDA rulemaking, and none has been proposed (Federal Register search, Oct 6, 2026). FDA's Pharmacy Compounding Advisory Committee discussed 7 of them on July 23 and 24, 2026 (FDA meeting page). A committee vote is not an FDA rule. Show them in the tracker. What leaving Category 2 means.
FDA Status Records: 25 Peptides
Download CSVPeptides with a dated FDA status record: 8 FDA-approved, 2 in clinical development and 15 not approved in the US.
- 503A: 12 peptides with the nomination withdrawn, in no category
- 503A: 1 peptide in Category 1, under evaluation
- 503B: 3 peptides that FDA proposed not to include
Showing 25 peptides
FDA-approved (8)
- Cholecystokinin (CCK-8)FDA-approvedMetabolic
Research says: CCK-8 is a validated endogenous satiety hormone with strong IV human evidence for meal termination, gallbladder contraction, and gastric emptying delay.
Users say: No community use exists. Zero Reddit threads on r/peptides or r/Nootropics, zero biohacker protocols, zero self-administration reports found.
- FDA approvals cited
- Kinevac (NDA 017697), Sincalide (NDA 210850)
- Compounding lists
- No entry on FDA's 503A or 503B lists in the captured documents
- Sources
- Drugs@FDA NDA 017697, Kinevac (saved Oct 10, 2026) · Drugs@FDA NDA 210850, Sincalide (saved Oct 10, 2026)Checked
- Exenatide (Byetta / Bydureon)FDA-approvedWeight loss
Research says: FDA-approved GLP-1 RA for type 2 diabetes. Reduces HbA1c 0.8-1.0% and produces modest weight loss (~2-3 kg over 30 weeks). Key study: EXSCEL.
Users say: Historically positive for A1C reduction and weight loss in T2D patients.
- FDA approvals cited
- Byetta (NDA 021773, discontinued), Bydureon (NDA 022200, discontinued), Bydureon BCise (NDA 209210, discontinued), Exenatide injection (Amneal) (ANDA 206697)
- Compounding lists
- No entry on FDA's 503A or 503B lists in the captured documents
- Sources
- Drugs@FDA NDA 021773, Byetta (saved Oct 7, 2026) · Drugs@FDA NDA 022200, Bydureon (saved Oct 7, 2026) · Drugs@FDA NDA 209210, Bydureon BCise (saved Oct 7, 2026) · Drugs@FDA ANDA 206697, Exenatide Amneal (saved Oct 7, 2026)Checked
- GonadorelinFDA-approvedSexual health
Research says: Pulsatile GnRH stimulates LH/FSH release from anterior pituitary. No RCTs exist for bolus SC injection TRT co-administration. Key study: PMID 40119359.
Users say: Widely adopted as post-2020 HCG compounding ban substitute.
- FDA approvals cited
- Factrel (NDA 018123, discontinued), Lutrepulse Kit (NDA 019687, discontinued)
- Compounding lists
- No entry on FDA's 503A or 503B lists in the captured documents
- Sources
- Drugs@FDA NDA 018123, Factrel (saved Oct 10, 2026) · Drugs@FDA NDA 019687, Lutrepulse Kit (saved Oct 10, 2026)Checked
- LiraglutideFDA-approvedWeight loss
Research says: FDA-approved for chronic weight management (Saxenda, 3 mg/day) and type 2 diabetes (Victoza, up to 1.8 mg/day). Key study: SCALE Obesity and Prediabetes.
Users say: Regarded as the "old reliable" GLP-1: effective, well-understood, and now accessible via generic and compounding.
- FDA approvals cited
- Saxenda (NDA 206321)
- Compounding lists
- 503B: FDA proposed not to include (as of )
- Sources
- Drugs@FDA NDA 206321, Saxenda (saved Oct 6, 2026) · Federal Register 2026-08552 (saved Oct 6, 2026) · Federal Register 2026-12937 (saved Oct 6, 2026)Checked
- LixisenatideFDA-approvedWeight loss
Research says: Effective short-acting GLP-1 agonist for postprandial glucose reduction in T2DM; confirmed cardiovascular-neutral in ELIXA; Phase 2 signal for slowing Parkinson's motor progression (LIXIPARK 2024) warrants Phase 3… Key study: ELIXA cardiovascular outcomes trial.
Users say: Minimal community discussion post-US discontinuation.
- FDA approvals cited
- Adlyxin (BLA 208471, discontinued), Soliqua 100/33 (BLA 208673)
- Compounding lists
- No entry on FDA's 503A or 503B lists in the captured documents
- Sources
- Drugs@FDA BLA 208471, Adlyxin (saved Oct 7, 2026) · Drugs@FDA BLA 208673, Soliqua 100 33 (saved Oct 10, 2026) · purplebook data download 2026 09.csv (saved Oct 10, 2026)Checked
- OrforglipronNot a peptideFDA-approvedWeight loss
Research says: FDA-approved oral non-peptide GLP-1 agonist. Phase 3 shows 11.1-12.4% body weight loss (ITT/completers) at highest dose over 72 weeks. Key study: ATTAIN-1.
Users say: No community data yet: drug launched April 6, 2026.
- FDA approvals cited
- Foundayo (NDA 220934)
- Compounding lists
- No entry on FDA's 503A or 503B lists in the captured documents
- Sources
- Drugs@FDA NDA 220934, Foundayo (saved Oct 6, 2026)Checked
- SemaglutideFDA-approvedWeight loss
Research says: Unambiguous efficacy across three FDA indications (obesity, T2D, CV risk reduction). Key study: STEP 1.
Users say: Highest-discussed weight-loss intervention on Reddit by a wide margin (350k+ combined members across r/Ozempic and r/semaglutide).
- FDA approvals cited
- Ozempic (NDA 209637), Wegovy (NDA 215256)
- Compounding lists
- 503B: FDA proposed not to include (as of )
- Sources
- Drugs@FDA NDA 209637, Ozempic (saved Oct 6, 2026) · Drugs@FDA NDA 215256, Wegovy (saved Oct 6, 2026) · Federal Register 2026-08552 (saved Oct 6, 2026) · Federal Register 2026-12937 (saved Oct 6, 2026)Checked
- TirzepatideFDA-approvedWeight loss
Research says: FDA-approved dual GIP/GLP-1 agonist with the strongest weight-loss efficacy of any approved drug class. Key study: SURMOUNT-1.
Users say: Strongest community enthusiasm of any GLP-1. r/Zepbound users consistently report superior appetite suppression and weight loss vs their prior semaglutide experience.
- FDA approvals cited
- Mounjaro (NDA 215866), Zepbound (NDA 217806)
- Compounding lists
- 503B: FDA proposed not to include (as of )
- Sources
- Drugs@FDA NDA 215866, Mounjaro (saved Oct 6, 2026) · Drugs@FDA NDA 217806, Zepbound (saved Oct 6, 2026) · Federal Register 2026-08552 (saved Oct 6, 2026) · Federal Register 2026-12937 (saved Oct 6, 2026)Checked
In clinical development (2)
- CagriSemaIn clinical developmentWeight loss
Research says: Phase 3 REDEFINE program confirms 22.7% body weight loss (efficacy estimand, REDEFINE 1) in obesity without T2D at 68 weeks: highest of any NDA-filed weekly injectable as of April 2026. Key study: REDEFINE 1.
Users say: High interest driven by trial data. Actual grey-market access requires DIY stacking of separate research-grade cagrilintide + semaglutide.
- Compounding lists
- No entry on FDA's 503A or 503B lists in the captured documents
- Sources
- ClinicalTrials.gov NCT05669755 (saved Oct 7, 2026) · ClinicalTrials.gov NCT07357766 (saved Oct 6, 2026)Checked
- RetatrutideIn clinical developmentWeight loss
Research says: Phase 3 TRIUMPH-4 (Dec 2025) confirmed 28.7% mean body weight reduction at 68 weeks with 12 mg, and TRIUMPH-1 (NEJM 2026, n=2,339) reported 25.0% at 80 weeks counting everyone randomized. Key study: TRIUMPH-4 Phase 3.
Users say: Referred to as "Godzilla" and "Triple G" in weight-loss communities.
- Compounding lists
- No entry on FDA's 503A or 503B lists in the captured documents
- Sources
- ClinicalTrials.gov NCT07629401 (saved Oct 6, 2026)Checked
Not approved in the US (15)
- BPC-157Not approved in the USHealing
Research says: Strong preclinical evidence across 180+ PubMed papers (tendons, ligaments, gut mucosa, nerves, muscle). Key study: Vasireddi et al. 2025.
Users say: The most widely discussed healing peptide online. Standard protocol (250 mcg 2x/day SC near injury) dominates community consensus.
- Compounding lists
- 503A: Nomination withdrawn: in no category (as of )
- Sources
- FDA Category 2 page (saved Oct 6, 2026) · FDA 503A categories list (saved Oct 6, 2026)Checked
- DihexaNot approved in the USBrain
Research says: Severely weakened in 2024-2025. Two primary mechanistic papers retracted April 2025 (data fabrication confirmed). All efficacy evidence remains preclinical. Key study: Martino et al. 2025.
Users say: Moderate cautious interest persists despite scientific setbacks.
- Compounding lists
- 503A: Nomination withdrawn: in no category (as of )
- Sources
- FDA Category 2 page (saved Oct 6, 2026) · FDA 503A categories list (saved Oct 6, 2026)Checked
- DSIPNot approved in the USSleep
Research says: IV administration improved delta-wave sleep in small controlled human studies (1977-1992); effect sizes were modest and results inconsistent across labs. Key study: PMID 1299794.
Users say: Users consistently report improved sleep architecture (deeper slow-wave sleep, faster onset, reduced night waking) without grogginess or dependency.
- Compounding lists
- 503A: Nomination withdrawn: in no category (as of )
- Sources
- FDA Category 2 page (saved Oct 6, 2026) · FDA 503A categories list (saved Oct 6, 2026)Checked
- Enfuvirtide (Fuzeon)Not approved in the USImmune
Research says: Fixed 90 mg SC twice-daily dosing is validated by Phase III TORO-1 and TORO-2 trials (NEJM 2003) and confirmed through 96-week extension data. Key study: TORO-1 and TORO-2 Phase III trials.
Users say: Historically characterized by near-universal frustration with injection site reactions and twice-daily SC burden.
- FDA approvals cited
- Fuzeon (approval withdrawn August 5, 2026, 91 FR 41045) (NDA 021481, discontinued)
- Compounding lists
- No entry on FDA's 503A or 503B lists in the captured documents
- Sources
- Drugs@FDA NDA 021481, Fuzeon (saved Oct 10, 2026) · Federal Register 2026-13616 (saved Oct 10, 2026)Checked
- EpithalonNot approved in the USAnti-aging
Research says: Telomerase activation and telomere elongation confirmed in cell cultures (human and bovine). Key study: Al-Dulaimi et al.
Users say: Widely used in longevity and biohacker communities.
- Compounding lists
- 503A: Nomination withdrawn: in no category (as of )
- Sources
- FDA Category 2 page (saved Oct 6, 2026) · FDA 503A categories list (saved Oct 6, 2026)Checked
- GHK-CuNot approved in the USAnti-aging
Research says: Preclinical evidence is strong for collagen stimulation, wound healing, and gene expression modulation (4,000+ genes). Key study: Pickart et al.
Users say: Highly positive community reception. Consistently rated one of the most tolerated anti-aging peptides.
- Compounding lists
- 503A, injectable routes: Nomination withdrawn: in no category (as of )
- 503A, non-injectable routes: Category 1: under evaluation (as of )
- Sources
- FDA Category 2 page (saved Oct 6, 2026) · FDA 503A categories list (saved Oct 6, 2026)Checked
- KPVNot approved in the USImmune
Research says: Preclinical-only evidence. KPV inhibits NF-κB and suppresses pro-inflammatory cytokines (TNF-α, IL-1β, IL-6) in mouse colitis models via PepT1-mediated cellular uptake. Key study: Gastroenterology 2008.
Users say: Used primarily for gut inflammation (IBD, IBS, Crohn's, UC, leaky gut).
- Compounding lists
- 503A: Nomination withdrawn: in no category (as of )
- Sources
- FDA Category 2 page (saved Oct 6, 2026) · FDA 503A categories list (saved Oct 6, 2026)Checked
- LL-37Not approved in the USImmune
Research says: Wound healing is the only human-trial-supported use (topical application). Key study: Phase IIb HEAL trial.
Users say: Used primarily for chronic/recurrent infections, biofilm disruption, immune support, and wound healing via SC injection.
- Compounding lists
- 503A: Nomination withdrawn: in no category (as of )
- Sources
- FDA Category 2 page (saved Oct 6, 2026) · FDA 503A categories list (saved Oct 6, 2026)Checked
- Melanotan IINot approved in the USSexual health
Research says: MT-II produces reliable tanning via MC1R activation and pro-erectile effects via MC4R; established in Phase 1 and small Phase 2 human trials. Key study: Dorr et al. 1996 Phase 1.
Users say: Highly effective tanner for Fitzpatrick I, II skin types; significant libido/erection enhancement.
- Compounding lists
- 503A: Nomination withdrawn: in no category (as of )
- Sources
- FDA Category 2 page (saved Oct 6, 2026) · FDA 503A categories list (saved Oct 6, 2026)Checked
- MOTS-cNot approved in the USMetabolic
Research says: Well-established AMPK activator in preclinical models with confirmed exercise-mimetic, insulin-sensitizing, and anti-aging effects. Key study: Lee et al. 2015.
Users say: Positively regarded in metabolic health and longevity biohacker communities.
- Compounding lists
- 503A: Nomination withdrawn: in no category (as of )
- Sources
- FDA Category 2 page (saved Oct 6, 2026) · FDA 503A categories list (saved Oct 6, 2026)Checked
- Nesiritide (Natrecor)Not approved in the USHealing
Research says: Nesiritide reduces PCWP and improves dyspnea in ADHF (VMAC, 2002). Key study: ASCEND-HF.
Users say: No community or self-administration use exists. Nesiritide is a hospital-only IV drug discontinued from the US market.
- FDA approvals cited
- Natrecor (approval withdrawn June 15, 2020, 85 FR 28950) (NDA 020920, discontinued)
- Compounding lists
- No entry on FDA's 503A or 503B lists in the captured documents
- Sources
- Drugs@FDA NDA 020920, Natrecor (saved Oct 10, 2026) · Federal Register 2020-10367 (saved Oct 10, 2026) · Federal Register 2021-00118 (saved Oct 10, 2026)Checked
- PEG-MGFNot approved in the USMuscle & growth
Research says: Zero peer-reviewed studies exist for the bodybuilding PEGylated compound specifically. All evidence is extrapolated from native MGF / MGF-E peptide animal and cell studies. Key study: McKoy G et al. 2011.
Users say: Cautiously positive for recovery enhancement and DOMS reduction; skeptical for direct mass-building effects.
- Compounding lists
- 503A: Nomination withdrawn: in no category (as of )
- Sources
- FDA Category 2 page (saved Oct 6, 2026) · FDA 503A categories list (saved Oct 6, 2026)Checked
- SemaxNot approved in the USBrain
Research says: BDNF upregulation and neuroprotection are well-supported in rodent and cell models. Key study: Dolotov et al. 2006.
Users say: Widely regarded as one of the most reliable nootropic peptides.
- Compounding lists
- 503A: Nomination withdrawn: in no category (as of )
- Sources
- FDA Category 2 page (saved Oct 6, 2026) · FDA 503A categories list (saved Oct 6, 2026)Checked
- SermorelinNot approved in the USMuscle & growth
Research says: Mechanism well-established: sermorelin is the 1-29 N-terminal fragment of endogenous GHRH, fully retaining GHRH receptor (GHRH-R) binding activity and stimulating pulsatile GH release from the pituitary somatotrophs. Key study: Vittone et al. 1997.
Users say: Widely regarded as the most conservative, beginner-appropriate GH secretagogue. "Start here before CJC/Ipa" is the dominant consensus.
- FDA approvals cited
- Geref Diagnostic (approval withdrawn June 18, 2009, 74 FR 23407) (NDA 019863, discontinued), Geref (approval withdrawn June 18, 2009, 74 FR 23407) (NDA 020443, discontinued)
- Compounding lists
- No entry on FDA's 503A or 503B lists in the captured documents
- Sources
- Drugs@FDA NDA 019863, Geref (saved Oct 10, 2026) · Drugs@FDA NDA 020443, Geref (saved Oct 10, 2026) · fr E9 11628 withdrawal 92 ndas 49 andas govinfo (saved Oct 10, 2026) · Federal Register 2013-04827 (saved Oct 10, 2026)Checked
- TB-500Not approved in the USHealing
Research says: Strong preclinical evidence for thymosin beta-4 and its active fragment in wound healing, angiogenesis (VEGF upregulation 2.5-3.8×), and actin-mediated cell migration. Key study: Malinda et al. 1999.
Users say: One of the most trusted healing peptides in the research community (4.1/5 sentiment, 500+ r/Peptides threads).
- Compounding lists
- 503A: Nomination withdrawn: in no category (as of )
- Sources
- FDA Category 2 page (saved Oct 6, 2026) · FDA 503A categories list (saved Oct 6, 2026)Checked
FDA Applications Behind Each Approved Peptide
In all, 35 peptides on this site have at least one FDA approval. Of those, 33 still have a product a doctor can prescribe, listed with prescription status in FDA's records (1 only inside a combination product). The other 2 are approved, but every product listed is discontinued. The table also lists 3 peptides whose approvals FDA withdrew, each with its Federal Register notice: enfuvirtide (Fuzeon), nesiritide (Natrecor) and sermorelin (Geref). Each application links to the FDA record saved on this site. To browse them by goal, use the FDA-approved peptides explorer.
| Peptide | FDA-approved products | First dated approval | FDA status |
|---|---|---|---|
| Acthar NDA 007504 (corticotropin), discontinuedActhar Gel / Acthar Gel (Autoinjector) NDA 008372 (corticotropin)Purified Cortrophin Gel NDA 008975 (corticotropin)Cortrosyn NDA 016750 (cosyntropin) | 1950 | Prescription (some products discontinued) | |
| Angiomax NDA 020873Angiomax RTU NDA 211215Bivalirudin in 0.9% Sodium Chloride NDA 208374, discontinued | 2000 | Prescription (some products discontinued) | |
| Calcimar NDA 017769 (calcitonin salmon), discontinuedMiacalcin NDA 017808 (calcitonin salmon)Miacalcin NDA 020313 (calcitonin salmon), discontinuedFortical NDA 021406 (calcitonin salmon recombinant), discontinuedCalcimar NDA 017497 (calcitonin salmon), discontinued | 1978* | Prescription (some products discontinued) | |
| Kinevac NDA 017697Sincalide NDA 210850 | 1976 | Prescription | |
| DDAVP (Needs No Refrigeration) / DDAVP NDA 017922, discontinuedDDAVP NDA 018938DDAVP NDA 019955Desmoda NDA 219873 | 1978 | Prescription (some products discontinued) | |
| Trulicity BLA 125469 | 2014 | Prescription (some products discontinued) | |
| Fuzeon NDA 021481, approval withdrawn 2026 (91 FR 41045) | 2003 | Approval withdrawn in 2026 | |
| Integrilin NDA 020718, discontinuedEptifibatide ANDA 090854 | 1998 | Prescription (some products discontinued) | |
| Byetta NDA 021773, discontinuedBydureon Pen / Bydureon NDA 022200, discontinuedBydureon BCise NDA 209210, discontinuedExenatide Synthetic ANDA 206697 | 2005 | Prescription (some products discontinued) | |
| Glucagon NDA 012122 (glucagon hydrochloride), discontinuedGlucaGen NDA 020918 (glucagon hydrochloride), discontinuedBaqsimi NDA 210134 (glucagon)Gvoke Kit / Gvoke HypoPen / Gvoke PFS / Gvoke VialDx NDA 212097 (glucagon) | 1960 | Prescription (some products discontinued) | |
| Factrel NDA 018123 (gonadorelin hydrochloride), discontinuedLutrepulse Kit NDA 019687 (gonadorelin acetate), discontinued | 1982 | Discontinued | |
| Pregnyl BLA 017692, NDA until 2020Novarel BLA 017016, NDA until 2020Chorionic Gonadotropin BLA 017067, NDA until 2020A.P.L. BLA 017055, NDA until 2020, discontinued | 1973* | Prescription (some products discontinued) | |
HGH (Somatropin)Also listed as HGH 191AA | Humatrope BLA 019640, NDA until 2020Genotropin BLA 020280, NDA until 2020Norditropin BLA 021148, NDA until 2020Omnitrope BLA 021426, NDA until 2020 | 1986* | Prescription (some products discontinued) |
| Firazyr NDA 022150 | 2011 | Prescription | |
| Somatuline Depot NDA 022074Lanreotide Acetate NDA 215395 | 2007 | Prescription | |
| Lupron NDA 019010 (leuprolide acetate), discontinuedLupron Depot NDA 019732 (leuprolide acetate)Eligard Kit NDA 021343 (leuprolide acetate)Camcevi Kit NDA 211488 (leuprolide mesylate) | 1985 | Prescription (some products discontinued) | |
| Linzess NDA 202811 | 2012 | Prescription | |
| Victoza NDA 022341Saxenda NDA 206321Liraglutide ANDA 215503 | 2010 | Prescription | |
| Adlyxin BLA 208471, NDA until 2020, discontinuedSoliqua 100/33 BLA 208673, NDA until 2020, combination with insulin glargine | 2016 | Prescription, in combination only | |
| Scenesse NDA 210797 | 2019 | Prescription | |
| Natrecor NDA 020920, approval withdrawn 2020 (85 FR 28950) | 2001 | Approval withdrawn in 2020 | |
| Sandostatin NDA 019667Sandostatin LAR NDA 021008Mycapssa NDA 208232Bynfezia Pen NDA 213224 | 1988 | Prescription (some products discontinued) | |
| Pitocin NDA 018261Syntocinon NDA 018245, discontinuedSyntocinon NDA 012285, discontinued | 1980* | Prescription (some products discontinued) | |
| Signifor NDA 200677 (pasireotide diaspartate)Signifor LAR Kit NDA 203255 (pasireotide pamoate) | 2012 | Prescription | |
| Trulance NDA 208745 | 2017 | Prescription | |
| Symlin NDA 021332, discontinued | 2005 | Discontinued | |
| Vyleesi (Autoinjector) NDA 210557 | 2019 | Prescription | |
| Nplate BLA 125268 | 2008 | Prescription | |
| Ozempic NDA 209637Ozempic / Rybelsus NDA 213051Wegovy / Wegovy HD / Wegovy FlexTouch NDA 215256Wegovy NDA 218316 | 2017 | Prescription (some products discontinued) | |
| Geref NDA 019863, approval withdrawn 2009 (74 FR 23407)Geref NDA 020443, approval withdrawn 2009 (74 FR 23407) | 1990 | Approval withdrawn in 2009 | |
| Imcivree NDA 213793 | 2020 | Prescription | |
| Forzinity NDA 215244 | 2025 | Prescription | |
| Gattex Kit NDA 203441 | 2012 | Prescription | |
| Egrifta / Egrifta SV / Egrifta WR BLA 022505, NDA until 2020 | 2010 | Prescription (some products discontinued) | |
| Mounjaro / Mounjaro KwikPen / Mounjaro (Autoinjector) NDA 215866Zepbound / Zepbound KwikPen / Zepbound (Autoinjector) NDA 217806 | 2022 | Prescription | |
| Trelstar NDA 020715Triptodur Kit NDA 208956 | 2000 | Prescription | |
| Pitressin Tannate NDA 003402 (vasopressin tannate), discontinuedVasostrict NDA 204485 (vasopressin)Vasopressin NDA 212593 (vasopressin)Vasopressin in Sodium Chloride 0.9% NDA 217569 (vasopressin) | 2014* | Prescription (some products discontinued) | |
| Prialt NDA 021060 | 2004 | Prescription (some products discontinued) |
* FDA's records show this ingredient was approved or sold before that year: either an older application with no date, or a first dated approval that FDA does not class as a new ingredient. For Humatrope, FDA's 2020 transition list says March 8, 1987, while Drugs@FDA and the Purple Book say October 16, 1986.
The table shows key applications for each peptide, including a generic where no brand is still sold. It is not every application FDA holds.
The list follows this site's catalog, which includes some protein hormones and fusion proteins that FDA licenses as biologics (BLAs). Applications marked "NDA until 2020" were drug applications that were deemed biologics licenses on March 23, 2020, as the law required for proteins, per FDA's transition list.
Also FDA-approved but not peptides, so not listed: TRT (Testosterone Replacement Therapy), L-Carnitine, Orforglipron.
Records: Drugs@FDA through openFDA as of , and for biologics the FDA Purple Book as of September 2026. Retrieved .
Recent Regulatory Changes
- Regulatory
FDA added a major adverse cardiovascular event risk indication in type 2 diabetes to Mounjaro (S-044, S-045) on Aug 27, 2026, per the updated FDA label.
What this does not mean: SURPASS-CVOT showed noninferiority to dulaglutide, not superiority. Zepbound did not gain this indication.
Peptides: Tirzepatide
Source: Mounjaro (tirzepatide) prescribing information (openFDA label record, SPL version 40, effective Aug 27, 2026) · Saved copy
- Regulatory
PCAC backed Semax for the 503A bulks list 8-5-1 on Jul 24, 2026, per a law-firm summary; reported from the meeting; FDA has not posted minutes.
What this does not mean: The vote did not add it to the 503A bulks list. FDA must complete notice-and-comment rulemaking first, and no proposed or final rule exists (Federal Register search, Oct 6, 2026).
Peptides: Semax
Source: FDA meeting page, Pharmacy Compounding Advisory Committee, July 23-24, 2026 (content current as of 08/06/2026) · Reported by Law-firm client alert, "Bulk-list bound? PCAC backs majority of peptides in two-day public meeting" (Jul 27, 2026) · Saved copy
- Regulatory
PCAC recommended epitalon for the 503A bulks list on Jul 24, 2026, per a law-firm summary; reported from the meeting; FDA has not posted minutes.
What this does not mean: The vote did not add it to the 503A bulks list. FDA must complete notice-and-comment rulemaking first, and no proposed or final rule exists (Federal Register search, Oct 6, 2026).
Peptides: Epithalon
Source: FDA meeting page, Pharmacy Compounding Advisory Committee, July 23-24, 2026 (content current as of 08/06/2026) · Reported by Law-firm client alert, "Bulk-list bound? PCAC backs majority of peptides in two-day public meeting" (Jul 27, 2026) · Saved copy
- Regulatory
PCAC did not back emideltide (DSIP) for the 503A list 6-7-1 on Jul 24, 2026, per a law-firm summary; reported from the meeting; FDA has not posted minutes.
What this does not mean: The vote is advice to FDA, not a decision. Emideltide stays off the 503A bulks list unless FDA adds it by notice-and-comment rule.
Peptides: DSIP
Source: FDA meeting page, Pharmacy Compounding Advisory Committee, July 23-24, 2026 (content current as of 08/06/2026) · Reported by Law-firm client alert, "Bulk-list bound? PCAC backs majority of peptides in two-day public meeting" (Jul 27, 2026) · Saved copy
- Regulatory
PCAC backed TB-500 for the 503A bulks list 8-6-1 on Jul 23, 2026, per a law-firm summary; reported from the meeting; FDA has not posted minutes.
What this does not mean: The vote did not add it to the 503A bulks list. FDA must complete notice-and-comment rulemaking first, and no proposed or final rule exists (Federal Register search, Oct 6, 2026).
Peptides: TB-500
Source: FDA meeting page, Pharmacy Compounding Advisory Committee, July 23-24, 2026 (content current as of 08/06/2026) · Reported by Law-firm client alert, "Bulk-list bound? PCAC backs majority of peptides in two-day public meeting" (Jul 27, 2026) · Saved copy
- Regulatory
PCAC backed MOTS-c for the 503A bulks list 7-5-2 on Jul 23, 2026, per a law-firm summary; reported from the meeting; FDA has not posted minutes.
What this does not mean: The vote did not add it to the 503A bulks list. FDA must complete notice-and-comment rulemaking first, and no proposed or final rule exists (Federal Register search, Oct 6, 2026).
Peptides: MOTS-c
Source: FDA meeting page, Pharmacy Compounding Advisory Committee, July 23-24, 2026 (content current as of 08/06/2026) · Reported by Law-firm client alert, "Bulk-list bound? PCAC backs majority of peptides in two-day public meeting" (Jul 27, 2026) · Saved copy
- Regulatory
PCAC backed KPV for the 503A bulks list 8-6-1 on Jul 23, 2026, per a law-firm summary; reported from the meeting; FDA has not posted minutes.
What this does not mean: The vote did not add it to the 503A bulks list. FDA must complete notice-and-comment rulemaking first, and no proposed or final rule exists (Federal Register search, Oct 6, 2026).
Peptides: KPV
Source: FDA meeting page, Pharmacy Compounding Advisory Committee, July 23-24, 2026 (content current as of 08/06/2026) · Reported by Law-firm client alert, "Bulk-list bound? PCAC backs majority of peptides in two-day public meeting" (Jul 27, 2026) · Saved copy
- Regulatory
PCAC backed BPC-157 for the 503A bulks list 8-6-1 on Jul 23, 2026, per a law-firm summary; reported from the meeting; FDA has not posted minutes.
What this does not mean: The vote did not add it to the 503A bulks list. FDA must complete notice-and-comment rulemaking first, and no proposed or final rule exists (Federal Register search, Oct 6, 2026).
Peptides: BPC-157
Source: FDA meeting page, Pharmacy Compounding Advisory Committee, July 23-24, 2026 (content current as of 08/06/2026) · Reported by Law-firm client alert, "Bulk-list bound? PCAC backs majority of peptides in two-day public meeting" (Jul 27, 2026) · Saved copy
The full dated record, including the site's own corrections, lives on the changes page.
What the Terms Mean
- FDA-approved. At least one product containing the peptide has an FDA approval. The tracker names the application behind it.
- Approval withdrawn. FDA withdrew the approval, so no approved product is left. A maker can ask for this once a product is no longer sold. The tracker cites the Federal Register notice for each withdrawal.
- In clinical development. A company is testing the peptide in human trials, and no product is approved yet.
- Not approved in the US. No FDA-approved product exists and no company-sponsored US development is recorded.
- 503A and 503B. 503A covers pharmacies that compound for individual prescriptions. 503B covers outsourcing facilities. FDA keeps separate lists of the bulk substances each may use.
- Category 1. FDA is still evaluating the substance for the 503A bulks list.
- Category 2. FDA says the substance raises significant safety risks.
- Nomination withdrawn. The people who nominated the substance withdrew the nomination, so FDA lists it in no category.
- Proposed not to include. FDA has proposed leaving the substance off the 503B bulks list.
How This Tracker Is Built
Every value comes from an FDA document saved on this site: Drugs@FDA records, FDA drug labels, FDA's 503A categories list and 503B bulks list, and the Federal Register. The source links on each row open those saved copies, so a value still reads the same if FDA moves the original page.
The approvals listed are the FDA applications captured as sources for each row, not every approved product containing the peptide. Compounding dates are the version date of the FDA document, not the day a position began, which FDA often does not state. Each row also shows the day the values were last checked.
The FDA-approved list comes from Drugs@FDA, read through openFDA, and from FDA's Purple Book for products licensed as biologics. Each application links to the FDA response saved on this site.
Status for the other 125 peptides on this site is on each peptide's own page. A peptide joins this tracker when its FDA status is checked against FDA and ClinicalTrials.gov records and dated, and every change is logged on the changes page.
This page is general information about regulatory status, not legal or medical advice.
Cite or Reuse This Data
Peptide Schedule. Peptide Regulatory Tracker. Updated Oct 10, 2026. https://www.peptideschedule.com/research/peptide-regulatory-tracker
The table is licensed under CC BY 4.0. Reuse it freely if you credit Peptide Schedule, link to this page and the license, and note any changes. Download the CSV.