§ — Regulatory status tracker
FDA compounding and approval status of peptides — tracker
This page records the regulatory status of every peptide in the library, with the date of our last verification. It changes monthly. Bookmark it and check the date.
| Peptide | Researched for | Evidence | Regulatory status | As of |
|---|---|---|---|---|
| PT-141 | Hypoactive sexual desire disorder in women; erectile dysfunction in men (earlier programs). | A | FDA-approved (Vyleesi) for hypoactive sexual desire disorder in premenopausal women. Use in men or for other purposes is off-label. | 2026-09-06 |
| Semaglutide | Type 2 diabetes, obesity, cardiovascular outcomes, NASH, kidney outcomes, alcohol use, Alzheimer's disease. | A | FDA-approved for type 2 diabetes (Ozempic, Rybelsus), chronic weight management (Wegovy) and cardiovascular risk reduction in adults with obesity. Compounded versions are permitted only during declared shortages; shortage status must be verified. | 2026-09-06 |
| Sermorelin | Growth hormone deficiency; GH axis stimulation in adults. | A | Previously FDA-approved as Geref for pediatric growth hormone deficiency and diagnostic use; the approved product was discontinued in 2008 for commercial reasons. Widely compounded; its 503A basis must be verified against the current bulks list before publication. | 2026-09-06 |
| Tesamorelin | Visceral fat reduction in HIV lipodystrophy; NAFLD; cognitive function in older adults. | A | FDA-approved (Egrifta) for reduction of excess abdominal fat in HIV-infected adults with lipodystrophy. Use for any other purpose is off-label. | 2026-09-06 |
| Tirzepatide | Obesity, type 2 diabetes, sleep apnea, heart failure with preserved ejection fraction, cardiovascular outcomes. | A | FDA-approved for type 2 diabetes (Mounjaro), chronic weight management and obstructive sleep apnea in obesity (Zepbound). Compounding permitted only during declared shortages; shortage status must be verified. | 2026-09-06 |
| CJC-1295 | Sustained growth hormone and IGF-1 elevation in adults; body composition. | B | Not FDA-approved. Removed from 503A Category 2 in April 2026 following nomination withdrawal; not placed in Category 1. Compounding not covered by the 503A exemption. | 2026-09-06 |
| GHK-Cu | Skin aging, wound healing, hair growth, gene expression modulation. | B | Not an approved drug. Widely used as a cosmetic ingredient in topical products, which is regulated as a cosmetic, not a drug. Injectable use is not approved and its compounding status must be verified. | 2026-09-06 |
| Ipamorelin | Postoperative ileus (a completed phase 2 program); growth hormone release. | B | Not FDA-approved. Placed in 503A Category 2 in 2023. Its current category must be verified against the FDA bulks list before publication; it has not been listed in Category 1. | 2026-09-06 |
| Selank | Generalized anxiety disorder, cognitive function under stress. | B | Not FDA-approved. Not on the 503A Bulks List. Status against the current FDA list must be verified before publication. | 2026-09-06 |
| Semax | Ischemic stroke recovery, cognitive impairment, attention disorders. | B | Not FDA-approved. Reviewed by PCAC on July 24, 2026; FDA proposed not to add it to the 503A Bulks List. | 2026-09-06 |
| Thymosin alpha-1 | Hepatitis B and C adjunct, sepsis, vaccine response, cancer adjunct, COVID-19. | B | Not FDA-approved. Placed in 503A Category 2 in 2023. Current category must be verified against the FDA bulks list before publication. | 2026-09-06 |
| BPC-157 | Tendon, ligament and muscle healing; gastrointestinal mucosal protection; ulcerative colitis (the indication FDA reviewed in 2026). | C | Not FDA-approved for any use. Placed in 503A Category 2 in 2023 over immunogenicity and impurity concerns; removed from Category 2 on April 15, 2026 after nomination withdrawal — which is not a listing in Category 1. Reviewed by the Pharmacy Compounding Advisory Committee on July 23, 2026; FDA proposed not to add it to the 503A Bulks List. Compounding remains outside the 503A exemption until rulemaking concludes. | 2026-09-06 |
| Emideltide | Sleep induction, stress response, chronic pain, opioid withdrawal. | C | Not FDA-approved. Reviewed by PCAC on July 24, 2026; FDA proposed not to add it to the 503A Bulks List. | 2026-09-06 |
| KPV | Inflammatory bowel disease, skin inflammation. | C | Not FDA-approved. Reviewed by PCAC on July 23, 2026; FDA proposed not to add it to the 503A Bulks List. | 2026-09-06 |
| LL-37 | Chronic wound infection, biofilm disruption, venous leg ulcers. | C | Not FDA-approved. Previously withdrawn from review; FDA has announced a further PCAC meeting before the end of February 2027 to reconsider it for the 503A Bulks List. | 2026-09-06 |
| MOTS-c | Insulin sensitivity, exercise capacity, metabolic regulation, aging biology. | C | Not FDA-approved. Reviewed by PCAC on July 23, 2026; FDA proposed not to add it to the 503A Bulks List. Not eligible for compounding. | 2026-09-06 |
| TB-500 | Wound healing, cardiac tissue repair after injury, corneal healing. | C | Not FDA-approved. Removed from 503A Category 2 in April 2026; reviewed by PCAC on July 23, 2026 with FDA proposing not to list. Not eligible for 503A compounding. | 2026-09-06 |
| Epitalon | Telomerase activation, melatonin regulation, lifespan extension. | D | Not FDA-approved. Reviewed by PCAC on July 24, 2026; FDA proposed not to add it to the 503A Bulks List. | 2026-09-06 |
| Melanotan II | Skin tanning, erectile dysfunction (abandoned development). | D | Not FDA-approved; FDA has issued consumer warnings. Previously withdrawn from review; FDA has announced a further PCAC meeting before the end of February 2027 to reconsider it. | 2026-09-06 |
- Approved drug with randomized controlled trials for the approved indication
- Human clinical data exists, but no approval for the researched use
- Animal or in-vitro data only, no controlled human trials
- No published clinical data; use rests on anecdote
A
B
C
D
Reviewed September 2026 · Sources: FDA, EMA
This page reports on the state of research and regulation for orientation. It is not medical advice, not a recommendation for or against any substance, and not an offer. Regulatory status changes; the date shown is the date of our last verification. Discuss any treatment with a licensed physician.
01 — Recent changes
What moved, and when.
- 2026-07-23/24PCAC reviewed BPC-157, KPV, TB-500, MOTS-c, emideltide, epitalon and semax; FDA proposed not to add them to the 503A Bulks List. Committee narrowly backed six.
- 2026-04-15FDA removed twelve peptides from 503A Category 2, including BPC-157, TB-500 and CJC-1295 — without placing them in Category 1.
- 2027-02 (ann.)Further PCAC meeting announced to reconsider LL-37, dihexa, melanotan II, PEG-MGF.
Primary sources
- https://www.fda.gov/advisory-committees/advisory-committee-calendar/july-23-24-2026-meeting-pharmacy-compounding-advisory-committee-07232026
- https://www.fda.gov/drugs/human-drug-compounding/bulk-drug-substances-used-compounding-under-section-503a-fdc-act
- https://www.ema.europa.eu/en/medicines
- https://www.bfarm.de
This page reports on the state of research and regulation for orientation. It is not medical advice, not a recommendation for or against any substance, and not an offer. Regulatory status changes; the date shown is the date of our last verification. Discuss any treatment with a licensed physician.