🏛️ Regulatory Dashboard

Peptide FDA Status Tracker

Last updated: March 2026

Track the FDA approval status of every major peptide. From fully approved medications to research chemicals — know exactly where each compound stands in the regulatory pipeline.

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FDA Approved
0
In Clinical Trials
0
Not FDA-Regulated
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Tracked Peptides
Status:
Category:
FDA Pipeline

What Does FDA Status Mean?

🔬
Preclinical
Lab and animal studies only. No human trials. Compound is in very early research stages.
🧪
Phase 1
First human trials. Small groups (20–100 people). Tests safety and dosing. ~70% advance to Phase 2.
📊
Phase 2
Medium-scale trials (100–300 people). Tests efficacy and side effects. ~33% advance to Phase 3.
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Phase 3
Large-scale trials (1,000–3,000+ people). Confirms safety and efficacy. Required before FDA submission.
📋
FDA Review
Company submits NDA/BLA. FDA reviews all trial data (typically 6–12 months). Can request more data.
✅
FDA Approved
Compound is approved for specific indication(s). Available by prescription for approved uses.
FAQ

Common Questions

Is BPC-157 FDA approved?

No. BPC-157 is not FDA approved. It is a research peptide with no human clinical trials. The FDA has not evaluated BPC-157 for safety or efficacy. It is sold only as a research chemical and is not approved for human use in the US.

Which peptides are FDA approved in 2026?

FDA-approved peptides include: Semaglutide (Ozempic/Wegovy, 2021), Tirzepatide (Mounjaro/Zepbound, 2022-2023), Tesamorelin (Egrifta, 2010), PT-141/Bremelanotide (Vyleesi, 2019), Sermorelin (compounded, 1997), and Modafinil (Provigil, 1998 for narcolepsy).

When will retatrutide be FDA approved?

Retatrutide (by Eli Lilly) is in Phase 3 trials as of 2026. If Phase 3 results are strong, FDA approval could come in 2026–2027. Nothing is guaranteed — timelines can shift based on trial data and FDA review process.

Is TB-500 FDA approved?

No. TB-500 is a synthetic fragment of thymosin beta-4. It has not been FDA approved and is classified as a research chemical. It is not approved for human use in the United States.

What's the difference between FDA approved and research peptides?

FDA-approved compounds have completed rigorous clinical trials proving safety and efficacy for specific indications. Research peptides (BPC-157, TB-500, CJC-1295, etc.) have not completed this process. They are sold only for research purposes and carry unknown long-term risks. Using unapproved compounds is not sanctioned by the FDA.