Peptide Regulatory Status Tracker
Is it an FDA-approved medicine? Can it legally be compounded? Is it banned in sport? One row per peptide, each status with the official source we read and the date we read it.
56 peptides
| Peptide | U.S. FDA status | FDA compounding status (read 13 October 2026) | Sport (WADA 2026 List, read 12 Oct 2026) | Sources |
|---|---|---|---|---|
| AbaloparatideOther | Approved MedicineFDA approved (NDA 208743) for postmenopausal women and men with osteoporosis at high risk of fracture. | Approved drug: copies restrictedAbaloparatide is the active ingredient of FDA-approved Tymlos (NDA 208743, Drugs@FDA) and does not appear on any 503A/503B category list, the bulks lists, or the safety-risk page. | Not individually listedCheck the List and any therapeutic use exemption | FDA 503A category lists (14 May 2026)FDA 503B category lists (21 Mar 2025)Profile sources, checked 13 October 2026 |
| AfamelanotideSkin & Hair | Approved MedicineScenesse (NDA 210797, Clinuvel) is approved to increase pain-free light exposure in adult patients with a history of phototoxic reactions from erythropoietic protoporphyria. | Approved drug: copies restrictedAfamelanotide is the active ingredient of FDA-approved Scenesse (NDA 210797, Drugs@FDA) and does not appear on any 503A/503B category list, the bulks lists, or the safety-risk page. | Not individually listedCheck the List and any therapeutic use exemption | FDA 503A category lists (14 May 2026)FDA 503B category lists (21 Mar 2025)Profile sources, checked 13 October 2026 |
| AOD-9604Metabolic | Unapproved | On FDA safety-risk pageFDA concern: Compounded drugs containing AOD-9604 may pose significant risk for immunogenicity for certain routes of administration and may have complexities with regard to peptide-related impurities and API characterization. | S2 namedS2 Peptide hormones and growth factors, prohibited at all times | FDA safety-risk page (22 Apr 2026)FDA 503A category lists (14 May 2026)Profile sources, checked 13 October 2026 |
| ArgirelineSkin & Hair | Unapproved | 503A Category 3"Acetyl Hexapeptide-3" (Argireline) is in 503B Category 3 (nominated without adequate supporting information; not eligible for the interim enforcement policy) on the March 21, 2025 list; it is absent from the 503A categories and the safety-risk page. | S0 by definitionUnapproved substances are prohibited under S0 even when not named | FDA 503B category lists (21 Mar 2025)FDA 503B bulk substances pageProfile sources, checked 13 October 2026 |
| BPC-157Tissue repair research | Unapproved | On FDA safety-risk pageFDA concern: Compounded drugs containing BPC-157 may pose risk for immunogenicity for certain routes of administration and may have complexities with regard to peptide-related impurities and active pharmaceutical ingredient (API) characterization. | S0 namedS0 Non-approved substances, prohibited at all times | FDA safety-risk page (22 Apr 2026)FDA 503A category lists (14 May 2026)Profile sources, checked 13 October 2026 |
| BremelanotideReproductive | Approved MedicineFDA approved (NDA 210557) as Vyleesi subcutaneous autoinjector. | Approved drug: copies restrictedBremelanotide acetate is the active ingredient of FDA-approved Vyleesi (NDA 210557, Drugs@FDA) and does not appear on any 503A/503B category list, the bulks lists, or the safety-risk page. | Not individually listedCheck the List and any therapeutic use exemption | FDA 503A category lists (14 May 2026)FDA 503B category lists (21 Mar 2025)Profile sources, checked 13 October 2026 |
| CagrilintideMetabolic | Investigational | Not nominatedNot on any FDA compounding list read on the check date. | S0 by definitionUnapproved substances are prohibited under S0 even when not named | FDA safety-risk page (22 Apr 2026)FDA 503A category lists (14 May 2026)Profile sources, checked 13 October 2026 |
| CJC-1295Growth Hormone Axis | Unapproved | On FDA safety-risk pageFDA concern: Compounded drugs containing CJC-1295 may pose risk for immunogenicity for certain routes of administration and may have complexities with regard to for peptide-related impurities and API characterization. | S2 namedS2 Peptide hormones and growth factors, prohibited at all times | FDA safety-risk page (22 Apr 2026)FDA 503A category lists (14 May 2026)Profile sources, checked 13 October 2026 |
| DihexaNeuropeptide | Unapproved | On FDA safety-risk pageFDA concern: FDA has not identified any human exposure data on drug products containing dihexa acetate administered via any route of administration. | S0 by definitionUnapproved substances are prohibited under S0 even when not named | FDA safety-risk page (22 Apr 2026)FDA 503A category lists (14 May 2026)Profile sources, checked 11 October 2026 |
| DSIPNeuropeptide | Unapproved | On FDA safety-risk pageFDA concern: Compounded drugs containing emideltide may pose risk for immunogenicity for certain routes of administration and may have complexities with regard to peptide-related impurities and API characterization. | S0 by definitionUnapproved substances are prohibited under S0 even when not named | FDA safety-risk page (22 Apr 2026)FDA 503A category lists (14 May 2026)Profile sources, checked 11 October 2026 |
| DulaglutideMetabolic | Approved MedicineTrulicity (BLA 125469, Eli Lilly) is approved as an adjunct to diet and exercise to improve glycemic control in adults and pediatric patients 10 years and older with type 2 diabete | Approved drug: copies restrictedDulaglutide is the active ingredient of FDA-approved Trulicity (BLA 125469, Drugs@FDA); FDA's February 21, 2025 statement listed dulaglutide injection as in shortage, but "Dulaglutide Injection" was not on FDA's current-shortage index when read on 2026-10-13, and it is not on any 503A/503B category list or the safety-risk page. | Not individually listedCheck the List and any therapeutic use exemption | FDA GLP-1 compounding statementFDA 503A category lists (14 May 2026)Profile sources, checked 13 October 2026 |
| ElamipretideOther | Approved MedicineFDA accelerated approval (NDA 215244, September 19, 2025) as Forzinity to improve muscle strength in adult and pediatric patients with Barth syndrome who meet the label's minimum b | Approved drug: copies restrictedElamipretide hydrochloride is the active ingredient of FDA-approved Forzinity (NDA 215244, Drugs@FDA) and does not appear on any 503A/503B category list, the bulks lists, or the safety-risk page. | Not individually listedCheck the List and any therapeutic use exemption | FDA 503A category lists (14 May 2026)FDA 503B category lists (21 Mar 2025)Profile sources, checked 11 October 2026 |
| EpitalonLongevity | Unapproved | On FDA safety-risk pageFDA concern: Compounded drugs containing epitalon may pose risk for immunogenicity for certain routes of administration due to the potential for aggregation and peptide-related impurities. | S0 namedS0 Non-approved substances, prohibited at all times | FDA safety-risk page (22 Apr 2026)FDA 503A category lists (14 May 2026)Profile sources, checked 13 October 2026 |
| ExenatideMetabolic | Approved MedicineFDA approved: Byetta (NDA 021773) and Bydureon microsphere suspension (NDA 022200). | Approved drug: copies restrictedExenatide is the active ingredient of FDA-approved Byetta and Bydureon (Drugs@FDA; several presentations discontinued) and does not appear on any 503A/503B category list, the bulks lists, or the safety-risk page. | Not individually listedCheck the List and any therapeutic use exemption | FDA 503A category lists (14 May 2026)FDA 503B category lists (21 Mar 2025)Profile sources, checked 6 October 2026 |
| GHK-CuSkin & Hair | Unapproved | 503A Category 1FDA's 503A category list (May 14, 2026) places "GHK-Cu (except for injectable routes of administration)" in Category 1 (may be compounded under the interim enforcement policy pending evaluation) after it was removed on April 22, 2026 when nominations were withdrawn and added back on May 5, 2026 when a nominator retained its non-injectable nomination; "GHK-Cu (for injectable routes of administration)" sits in the safety-risk page's "nominated but withdrawn" table with an immunogenicity concern, and FDA has announced a PCAC review of GHK-Cu before the end of February 2027.FDA concern: Compounded injectable drugs containing GHK-Cu may pose risk for immunogenicity due to the potential for aggregation and peptide-related impurities. | S0 by definitionUnapproved substances are prohibited under S0 even when not named | FDA 503A category lists (14 May 2026)FDA 503A bulk substances pageProfile sources, checked 13 October 2026 |
| GhrelinMetabolic | Investigational | Not nominatedNot on any FDA compounding list read on the check date. | S0 by definitionUnapproved substances are prohibited under S0 even when not named | FDA safety-risk page (22 Apr 2026)FDA 503A category lists (14 May 2026)Profile sources, checked 13 October 2026 |
| GHRP-2Growth Hormone Axis | Unapproved | 503A Category 2GHRP-2 (for injectable and nasal routes of administration) is in 503B Category 2 (significant safety risks, added September 29, 2023) while "GHRP-2 (except for injectable and nasal routes)" is in 503B Category 1, and GHRP-2 is in 503A Category 3 (nominated without adequate support); pralmorelin/KP-102 has no Drugs@FDA approval record.FDA concern: Compounded drugs containing GHRP-2 for injectable and nasal administration may pose risk for immunogenicity due to the potential for aggregation and peptide-related impurities. | S2 namedS2 Peptide hormones and growth factors, prohibited at all times | FDA 503B category lists (21 Mar 2025)FDA safety-risk page (22 Apr 2026)Profile sources, checked 11 October 2026 |
| GHRP-6Growth Hormone Axis | Unapproved | 503A Category 2GHRP-6 is in 503B Category 2 (significant safety risks, added September 29, 2023) and in 503A Category 3 (nominated without adequate support).FDA concern: Compounded drugs containing GHRP-6 may pose risk for immunogenicity for certain routes of administration due to the potential for aggregation and peptide-related impurities. | S2 namedS2 Peptide hormones and growth factors, prohibited at all times | FDA 503B category lists (21 Mar 2025)FDA safety-risk page (22 Apr 2026)Profile sources, checked 11 October 2026 |
| GIPMetabolic | Investigational | Not nominatedNot on any FDA compounding list read on the check date. | S0 by definitionUnapproved substances are prohibited under S0 even when not named | FDA safety-risk page (22 Apr 2026)FDA 503A category lists (14 May 2026)Profile sources, checked 13 October 2026 |
| GLP-1Metabolic | Investigational | Not nominatedNot on any FDA compounding list read on the check date. | S0 by definitionUnapproved substances are prohibited under S0 even when not named | FDA safety-risk page (22 Apr 2026)FDA 503A category lists (14 May 2026)Profile sources, checked 13 October 2026 |
| GlucagonMetabolic | Approved MedicineFDA approved: GlucaGen (NDA 020918) injectable; Baqsimi (NDA 210134) nasal powder. | Approved drug: copies restrictedGlucagon is the active ingredient of FDA-approved glucagon injection kits, Baqsimi and GlucaGen and does not appear on any 503A/503B category list, the bulks lists, or the safety-risk page. | Not individually listedCheck the List and any therapeutic use exemption | FDA 503A category lists (14 May 2026)FDA 503B category lists (21 Mar 2025)Profile sources, checked 13 October 2026 |
| GonadorelinReproductive | Unapproved | 503A Category 1"Gonadorelin Acetate**" is in 503B Category 1 on the March 21, 2025 list, the double asterisk designating a component of an FDA-approved drug (Factrel NDA 018123 and Lutrepulse NDA 019687, both discontinued per Drugs@FDA); it does not appear in the 503A categories or on the safety-risk page. | S2 namedS2 Peptide hormones and growth factors, prohibited at all times | FDA 503B category lists (21 Mar 2025)FDA 503B bulk substances pageProfile sources, checked 11 October 2026 |
| HexarelinGrowth Hormone Axis | Unapproved | Not nominatedNot on any FDA compounding list read on the check date. | S2 namedS2 Peptide hormones and growth factors, prohibited at all times | FDA safety-risk page (22 Apr 2026)FDA 503A category lists (14 May 2026)Profile sources, checked 11 October 2026 |
| InsulinMetabolic | Approved MedicineFDA approved across multiple BLAs. | Approved drug: copies restrictedHuman insulin and insulin analogues are FDA-licensed biologics (Humulin, Novolin, Humalog, Novolog, Fiasp and others, Drugs@FDA) and insulin does not appear on any 503A/503B category list, the bulks lists, or the safety-risk page. | S4 namedS4 Hormone and metabolic modulators, prohibited at all times | FDA 503A category lists (14 May 2026)FDA 503B category lists (21 Mar 2025)Profile sources, checked 13 October 2026 |
| IpamorelinGrowth Hormone Axis | Unapproved | 503A Category 2Ipamorelin acetate is in 503B Category 2 (significant safety risks, added September 29, 2023); its 503A nomination was withdrawn so it also appears in the safety-risk page's "nominated but withdrawn" table, and at the October 29, 2024 PCAC meeting FDA proposed that Ipamorelin (free base) and Ipamorelin acetate NOT be included on the 503A bulks list, with the committee voting 0 yes / 12 no / 1 abstain on each.FDA concern: Compounded drugs containing Ipamorelin acetate may pose risk for immunogenicity for certain routes of administration due to the potential for aggregation or peptide-related impurities. | S2 namedS2 Peptide hormones and growth factors, prohibited at all times | FDA 503B category lists (21 Mar 2025)FDA safety-risk page (22 Apr 2026)Profile sources, checked 13 October 2026 |
| KisspeptinReproductive | Investigational | 503A Category 2Kisspeptin-10 is in 503A Category 2 (significant safety risks; not covered by the interim enforcement policy), added September 29, 2023 per the safety-risk page, and at the October 29, 2024 PCAC meeting FDA proposed it NOT be included on the 503A bulks list and the committee voted 0 yes / 11 no.FDA concern: Compounded drugs containing Kisspeptin-10 may pose risk for immunogenicity for certain routes of administration and may have complexities with regard to peptide-related impurities and API characterization. | S2 namedS2 Peptide hormones and growth factors, prohibited at all times | FDA 503A category lists (14 May 2026)FDA safety-risk page (22 Apr 2026)Profile sources, checked 11 October 2026 |
| KPVImmune | Unapproved | On FDA safety-risk pageFDA concern: FDA has not identified any human exposure data on drug products containing KPV administered via any route of administration. | S0 namedS0 Non-approved substances, prohibited at all times | FDA safety-risk page (22 Apr 2026)FDA 503A category lists (14 May 2026)Profile sources, checked 13 October 2026 |
| LanreotideGrowth Hormone Axis | Approved MedicineFDA approved (NDA 022074) as Somatuline Depot for acromegaly and GEP-NETs. | Approved drug: copies restrictedLanreotide acetate is the active ingredient of FDA-approved Somatuline Depot and approved generics/505(b)(2) products and does not appear on any 503A/503B category list, the bulks lists, or the safety-risk page. | Not individually listedCheck the List and any therapeutic use exemption | FDA 503A category lists (14 May 2026)FDA 503B category lists (21 Mar 2025)Profile sources, checked 13 October 2026 |
| LarazotideOther | Investigational | Not nominatedNot on any FDA compounding list read on the check date. | S0 namedS0 Non-approved substances, prohibited at all times | FDA safety-risk page (22 Apr 2026)FDA 503A category lists (14 May 2026)Profile sources, checked 13 October 2026 |
| LiraglutideMetabolic | Approved MedicineFDA approved: Victoza (NDA 022341) for T2D; Saxenda (NDA 206321) for chronic weight management. | Approved drug: copies restrictedLiraglutide is the active ingredient of FDA-approved Victoza and Saxenda and of approved generics; "Liraglutide Injection" was listed as currently in shortage on FDA's drug shortage index when read on 2026-10-13 (FDA's February 21, 2025 statement also listed it as in shortage), and it is not on any 503A/503B category list or the safety-risk page. | Not individually listedCheck the List and any therapeutic use exemption | FDA GLP-1 compounding statementFDA 503A category lists (14 May 2026)Profile sources, checked 6 October 2026 |
| LixisenatideMetabolic | Approved MedicineUnited States, checked 11 October 2026. | Approved drug: copies restrictedLixisenatide is the active ingredient of FDA-approved Adlyxin (BLA 208471) and Soliqua 100/33 (BLA 208673) per Drugs@FDA and does not appear on any 503A/503B category list, the bulks lists, or the safety-risk page. | Not individually listedCheck the List and any therapeutic use exemption | FDA 503A category lists (14 May 2026)FDA 503B category lists (21 Mar 2025)Profile sources, checked 11 October 2026 |
| LL-37Immune | Unapproved | On FDA safety-risk pageFDA concern: Compounded drugs containing cathelicidin LL-37 may pose risk for immunogenicity for certain routes of administration and may have complexities with regard to peptide-related impurities and API characterization. | S0 by definitionUnapproved substances are prohibited under S0 even when not named | FDA safety-risk page (22 Apr 2026)FDA 503A category lists (14 May 2026)Profile sources, checked 13 October 2026 |
| MatrixylSkin & Hair | Unapproved | Not nominatedNot on any FDA compounding list read on the check date. | S0 by definitionUnapproved substances are prohibited under S0 even when not named | FDA safety-risk page (22 Apr 2026)FDA 503A category lists (14 May 2026)Profile sources, checked 11 October 2026 |
| MazdutideMetabolic | Investigational | Not nominatedNot on any FDA compounding list read on the check date. | S0 by definitionUnapproved substances are prohibited under S0 even when not named | FDA safety-risk page (22 Apr 2026)FDA 503A category lists (14 May 2026)Profile sources, checked 13 October 2026 |
| Melanotan IISkin & Hair | Unapproved | On FDA safety-risk pageFDA concern: Compounded drugs containing Melanotan II may pose risk for immunogenicity for certain routes of administration due to the potential for aggregation or peptide-related impurities. | S0 namedS0 Non-approved substances, prohibited at all times | FDA safety-risk page (22 Apr 2026)FDA 503A category lists (14 May 2026)Profile sources, checked 13 October 2026 |
| MOTS-cLongevity | Unapproved | On FDA safety-risk pageFDA concern: Compounded drugs containing MOTs-C may pose significant risk for immunogenicity for certain routes of administration and may have complexities with regard to peptide-related impurities and API characterization. | S4 namedS4 Hormone and metabolic modulators, prohibited at all times | FDA safety-risk page (22 Apr 2026)FDA 503A category lists (14 May 2026)Profile sources, checked 13 October 2026 |
| OctreotideGrowth Hormone Axis | Approved MedicineFDA approved: Sandostatin (NDA 019667), Sandostatin LAR depot (NDA 021008), and generic formulations. | Approved drug: copies restrictedOctreotide acetate is the active ingredient of FDA-approved Sandostatin and many approved generics and does not appear on any 503A/503B category list, the bulks lists, or the safety-risk page. | Not individually listedCheck the List and any therapeutic use exemption | FDA 503A category lists (14 May 2026)FDA 503B category lists (21 Mar 2025)Profile sources, checked 6 October 2026 |
| OxytocinReproductive | Approved MedicineFDA approved (NDA 018261) for induction/augmentation of labor and postpartum hemorrhage control. | Approved drug: copies restrictedOxytocin is the active ingredient of FDA-approved Pitocin/oxytocin injections; "Oxytocin**" also appears in 503B Category 1 on the March 21, 2025 list, the double asterisk designating a component of an FDA-approved drug, and it is not on the safety-risk page. | Not individually listedCheck the List and any therapeutic use exemption | FDA 503A category lists (14 May 2026)FDA 503B category lists (21 Mar 2025)Profile sources, checked 13 October 2026 |
| PemvidutideMetabolic | Investigational | Not nominatedNot on any FDA compounding list read on the check date. | S0 by definitionUnapproved substances are prohibited under S0 even when not named | FDA safety-risk page (22 Apr 2026)FDA 503A category lists (14 May 2026)Profile sources, checked 13 October 2026 |
| Peptide YYMetabolic | Investigational | Not nominatedNot on any FDA compounding list read on the check date. | S0 by definitionUnapproved substances are prohibited under S0 even when not named | FDA safety-risk page (22 Apr 2026)FDA 503A category lists (14 May 2026)Profile sources, checked 13 October 2026 |
| PramlintideMetabolic | Approved MedicineFDA approved (NDA 021332) as Symlin injection; carries boxed warning for severe hypoglycemia with co-administered insulin. | Approved drug: copies restrictedPramlintide acetate is the active ingredient of FDA-approved Symlin (NDA 021332, listed as discontinued in Drugs@FDA) and does not appear on any 503A/503B category list, the bulks lists, or the safety-risk page. | Not individually listedCheck the List and any therapeutic use exemption | FDA 503A category lists (14 May 2026)FDA 503B category lists (21 Mar 2025)Profile sources, checked 13 October 2026 |
| RetatrutideMetabolic | Investigational | Not nominatedNot on any FDA compounding list read on the check date. | S0 by definitionUnapproved substances are prohibited under S0 even when not named | FDA safety-risk page (22 Apr 2026)FDA 503A category lists (14 May 2026)Profile sources, checked 13 October 2026 |
| SelankNeuropeptide | Unapproved | On FDA safety-risk pageFDA concern: Compounded drugs containing selank acetate may pose risk for immunogenicity for certain routes of administration due to the potential for aggregation and peptide-related impurities. | S0 by definitionUnapproved substances are prohibited under S0 even when not named | FDA safety-risk page (22 Apr 2026)FDA 503A category lists (14 May 2026)Profile sources, checked 13 October 2026 |
| SemaglutideMetabolic | Approved MedicineOzempic injection covers type 2 diabetes and specified cardiovascular/kidney risk indications. | Approved drug: copies restrictedSemaglutide is the active ingredient of FDA-approved Ozempic, Wegovy and Rybelsus; FDA determined the semaglutide injection shortage resolved on February 21, 2025, ending enforcement discretion for 503A compounders on April 22, 2025 and for 503B outsourcing facilities on May 22, 2025, and FDA's GLP-1 page (10/01/2026) says "Tirzepatide and semaglutide do not currently appear on the 503B bulks list or on FDA's drug shortage list", that salt forms (semaglutide sodium/acetate) have no lawful basis for use in compounding, and that Import Alert 66-80 (published 10/09/2026) allows detention without physical examination of foreign GLP-1 APIs not on its Green List. | Not individually listedCheck the List and any therapeutic use exemption | FDA GLP-1 compounding statementFDA 503A category lists (14 May 2026)Profile sources, checked 10 October 2026 |
| SemaxNeuropeptide | Unapproved | On FDA safety-risk pageFDA concern: Compounded drugs containing semax (heptapeptide) may pose risk for immunogenicity for certain routes of administration due to the potential for aggregation and peptide-related impurities. | S0 by definitionUnapproved substances are prohibited under S0 even when not named | FDA safety-risk page (22 Apr 2026)FDA 503A category lists (14 May 2026)Profile sources, checked 13 October 2026 |
| SermorelinGrowth Hormone Axis | Unapproved | 503A Category 1"Sermorelin Acetate**" is in 503B Category 1 on the March 21, 2025 list, the double asterisk designating a bulk drug substance that is a component of an FDA-approved drug (Geref, NDA 019863/020443, both discontinued per Drugs@FDA); it does not appear in the 503A categories (approved-drug components are not placed there) or on the safety-risk page. | S2 namedS2 Peptide hormones and growth factors, prohibited at all times | FDA 503B category lists (21 Mar 2025)FDA 503B bulk substances pageProfile sources, checked 11 October 2026 |
| SetmelanotideMetabolic | Approved MedicineImcivree (NDA 213793, Rhythm Pharmaceuticals) is approved to reduce excess body weight and maintain weight reduction long term in patients 2 years and older with Bardet-Biedl syndr | Approved drug: copies restrictedSetmelanotide acetate is the active ingredient of FDA-approved Imcivree (NDA 213793, Drugs@FDA) and does not appear on any 503A/503B category list, the bulks lists, or the safety-risk page. | Not individually listedCheck the List and any therapeutic use exemption | FDA 503A category lists (14 May 2026)FDA 503B category lists (21 Mar 2025)Profile sources, checked 13 October 2026 |
| SNAP-8Skin & Hair | Unapproved | Not nominatedNot on any FDA compounding list read on the check date. | S0 by definitionUnapproved substances are prohibited under S0 even when not named | FDA safety-risk page (22 Apr 2026)FDA 503A category lists (14 May 2026)Profile sources, checked 11 October 2026 |
| SurvodutideMetabolic | Investigational | Not nominatedNot on any FDA compounding list read on the check date. | S0 by definitionUnapproved substances are prohibited under S0 even when not named | FDA safety-risk page (22 Apr 2026)FDA 503A category lists (14 May 2026)Profile sources, checked 13 October 2026 |
| TB-500Tissue repair research | Unapproved | On FDA safety-risk pageFDA concern: Compounded drugs containing thymosin Beta-4, Fragment (LKKTETQ) may pose risk for immunogenicity for certain routes of administration due to the potential for aggregation as well as peptide-related impurities. | S2 namedS2 Peptide hormones and growth factors, prohibited at all times | FDA safety-risk page (22 Apr 2026)FDA 503A category lists (14 May 2026)Profile sources, checked 13 October 2026 |
| TeriparatideOther | Approved MedicineFDA approved (NDA 021318) for severe osteoporosis in postmenopausal women and men at high risk. | Approved drug: copies restrictedTeriparatide is the active ingredient of FDA-approved Forteo, Bonsity and approved generics and does not appear on any 503A/503B category list, the bulks lists, or the safety-risk page. | Not individually listedCheck the List and any therapeutic use exemption | FDA 503A category lists (14 May 2026)FDA 503B category lists (21 Mar 2025)Profile sources, checked 13 October 2026 |
| TesamorelinGrowth Hormone Axis | Approved MedicineFDA approved (BLA 022505). | Approved drug: copies restrictedTesamorelin acetate is the active ingredient of FDA-approved Egrifta (BLA 022505, Drugs@FDA) and does not appear on any 503A/503B category list, the 503A or 503B bulks lists, or the safety-risk page. | S2 namedS2 Peptide hormones and growth factors, prohibited at all times | FDA 503A category lists (14 May 2026)FDA 503B category lists (21 Mar 2025)Profile sources, checked 13 October 2026 |
| Thymosin Alpha-1Immune | Unapproved | On FDA safety-risk pageFDA concern: Compounded drugs containing thymosin-alpha-1 (Ta1) may pose significant risk for immunogenicity for certain routes of administration and may have complexities with regard to peptide-related impurities and API characterization. | S0 by definitionUnapproved substances are prohibited under S0 even when not named | FDA safety-risk page (22 Apr 2026)FDA 503A category lists (14 May 2026)Profile sources, checked 11 October 2026 |
| TirzepatideMetabolic | Approved MedicineMounjaro is indicated for glycemic control in adults and children aged 10 years and older with type 2 diabetes. | Approved drug: copies restrictedTirzepatide is the active ingredient of FDA-approved Mounjaro and Zepbound; FDA first declared the tirzepatide injection shortage resolved on October 2, 2024, re-affirmed that decision on December 19, 2024 after litigation, and the enforcement-discretion periods for compounded copies ended February 18, 2025 (503A) and March 19, 2025 (503B), with FDA's GLP-1 page (10/01/2026) stating "Tirzepatide and semaglutide do not currently appear on the 503B bulks list or on FDA's drug shortage list" and Import Alert 66-80 (published 10/09/2026) covering foreign GLP-1 APIs. | Not individually listedCheck the List and any therapeutic use exemption | FDA GLP-1 compounding statementFDA 503A category lists (14 May 2026)Profile sources, checked 13 October 2026 |
| VasopressinMetabolic | Approved MedicineFDA approved (NDA 204485) for increasing blood pressure in vasodilatory septic shock. | Approved drug: copies restrictedVasopressin is the active ingredient of FDA-approved Vasostrict and approved generics and does not appear on any 503A/503B category list, the bulks lists, or the safety-risk page. | Not individually listedCheck the List and any therapeutic use exemption | FDA 503A category lists (14 May 2026)FDA 503B category lists (21 Mar 2025)Profile sources, checked 13 October 2026 |
| VIP (Vasoactive Intestinal Peptide)Other | Investigational | 503A Category 1"Vasoactive Intestinal Peptide" is in 503A Category 1 (nominated with sufficient information, under evaluation, may be compounded under the interim enforcement policy) on the May 14, 2026 list; it is not on the 503B lists or the safety-risk page, and aviptadil has no Drugs@FDA approval record. | S0 by definitionUnapproved substances are prohibited under S0 even when not named | FDA 503A category lists (14 May 2026)FDA 503A bulk substances pageProfile sources, checked 11 October 2026 |
What the statuses mean
U.S. FDA status
- Approved Medicine
- A specific medicine containing the peptide has FDA marketing approval for stated uses. Approval covers that product, formulation and indication, not the ingredient in general.
- Investigational
- The peptide is being studied in registered clinical trials or is a native hormone without an approved product. Nothing is approved for sale as a medicine.
- Unapproved
- No FDA-approved medicine contains the peptide. Products sold under its name are not approved drugs, whatever the label says.
FDA compounding status
Compounding pharmacies may only use a bulk substance that is on an FDA list, in an approved drug or in a USP monograph. FDA sorts nominated substances into categories under an interim policy and keeps a separate page of substances it considers risky. The labels below follow FDA's own lists.
- On FDA safety-risk page 14 peptides
- Listed on FDA’s page of bulk drug substances that may present significant safety risks in compounding. These were nominated for the 503A list, placed in Category 2, then withdrawn by their nominators, so they are on no current compounding list; FDA states its safety concern and, for most, is continuing its own evaluation through the compounding advisory committee.
- 503A Category 2 4 peptides
- Nominated for the 503A bulks list and placed by FDA in Category 2: FDA identified significant safety risks, and it may not be used in compounding while FDA evaluates it.
- 503A Category 1 4 peptides
- Nominated for the 503A bulks list and placed in Category 1: FDA has not finished evaluating it, and it may be compounded under FDA’s interim policy pending that evaluation.
- 503A Category 3 1 peptide
- Nominated with insufficient supporting information for FDA to evaluate; may not be compounded under the interim policy.
- Approved drug: copies restricted 20 peptides
- The substance is the active ingredient of an FDA-approved medicine. Compounders may not routinely make copies of available approved drugs; FDA allows exceptions, for example during a declared shortage.
- Not nominated 13 peptides
- Not on any FDA compounding list we read. It is not eligible for bulk compounding unless it meets another legal basis (for example a USP monograph).
Sport (WADA)
The World Anti-Doping Agency's Prohibited List applies to athletes under the Code. Substances named in sections S2 (peptide hormones, growth factors and related substances) or S4 (hormone and metabolic modulators) are prohibited at all times. Section S0 prohibits any substance with no current approval by a governmental health authority for human use, so unapproved peptides are prohibited even when the List does not name them. Approved medicines may be permitted with a therapeutic use exemption. See our guide to WADA peptide rules.
How this tracker is built
- FDA approval status is taken from each profile, where it is verified against Drugs@FDA and product labels on the date shown.
- Compounding status was read directly from FDA's bulk drug substance pages and Federal Register notices on 13 October 2026; the pages are linked in each row. "Not nominated" means the peptide did not appear on any list we read.
- WADA status was read from the 2026 Prohibited List (effective 1 January 2026) on 12 October 2026. "Named" means the substance appears by name; "S0 by definition" is our reading of the S0 rule for unapproved substances, which an anti-doping organisation applies case by case.
- Not covered: state pharmacy law, controlled-substance scheduling, customs and import rules, and the laws of other countries. Approval elsewhere (for example in China, Japan or Russia) is noted on the profile where we have a source.
- Updates. FDA lists and the WADA List change; we re-check before each edition and log changes under our corrections policy.
Cite or link to this page
Reference
Inside Peptides. (2026, October 13). Peptide Regulatory Status Tracker. https://insidepeptides.org/tools/peptide-regulatory-tracker/HTML link
<a href="https://insidepeptides.org/tools/peptide-regulatory-tracker/">Peptide Regulatory Status Tracker</a> (Inside Peptides)