FDA Status Tracker
A regularly updated reference showing the current FDA and regulatory status of every peptide covered on this site. All status information is date-stamped for transparency.
This FDA Status Tracker provides a comprehensive, continuously updated reference for the regulatory approval status of peptides discussed throughout PeptideLibraryHub.com. Whether a peptide is FDA-approved for specific indications, currently in clinical trials, or not yet approved, this page aims to clarify the distinction and help you understand what each status means for research and educational purposes. This information is reviewed and updated quarterly to reflect the latest regulatory developments.
Understanding FDA status is critical for several reasons: FDA-approved medications have undergone rigorous clinical testing and demonstrate safety and efficacy for their labeled indications, whereas investigational compounds still being studied in clinical trials are not yet approved and remain restricted to research settings. Additionally, some peptides may be approved in other countries but not yet by the FDA, and some have been added to the FDA's Category 2 Demonstrably Difficult to Compound list, which restricts their compounding by pharmacies. This tracker helps you navigate these distinctions with clarity and confidence.
| Peptide Name | FDA Approval Status | Approved Indication | Brand Name | Clinical Trial Phase | Category 2 | Last Updated |
|---|---|---|---|---|---|---|
| Semaglutide | FDA-Approved | Type 2 Diabetes, Obesity/Weight Management | Ozempic, Wegovy, Rybelsus | Phase 4 / Post-market | No | April 2026 |
| Tirzepatide | FDA-Approved | Type 2 Diabetes, Obesity/Weight Management | Mounjaro, Zepbound | Phase 4 / Post-market | No | April 2026 |
| Retatrutide | In Clinical Trials | N/A (Investigational) | N/A | Phase 3 (TRIUMPH program) | No | April 2026 |
| Tesamorelin | FDA-Approved | HIV-Associated Lipodystrophy (labeled indication only) | Egrifta, Egrifta SV | N/A | No | April 2026 |
| PT-141 (Bremelanotide) | FDA-Approved | HSDD in Premenopausal Women (labeled indication only) | Vyleesi | N/A | No | April 2026 |
| BPC-157 | Not Approved | N/A | N/A | No registered human trials | Yes (Sept 2023) | April 2026 |
| TB-500 (Thymosin Beta-4) | Not Approved | N/A | N/A | Phase 2 (Corneal healing. RegeneRx) | No | April 2026 |
| CJC-1295 | Not Approved | N/A | N/A | Discontinued (ConjuChem) | No | April 2026 |
| Ipamorelin | Not Approved | N/A | N/A | No active trials | No | April 2026 |
| GHK-Cu | Not Approved | N/A | N/A | No registered trials | No | April 2026 |
| Thymosin Alpha-1 | Approved Outside US | Approved in 30+ countries for HBV/HCV; Not FDA-Approved in US | Zadaxin | No active US trials | No | April 2026 |
| KPV | Not Approved | N/A | N/A | No registered trials | No | April 2026 |
| Epithalon | Not Approved | N/A | N/A | No registered trials | No | April 2026 |
| Selank | Approved Outside US | Approved in Russia as anxiolytic; Not FDA-Approved in US | N/A | No US trials | No | April 2026 |
| Semax | Approved Outside US | Approved in Russia for stroke/cognitive; Not FDA-Approved in US | N/A | No US trials | No | April 2026 |
| MOTS-C | Not Approved | N/A | N/A | Early clinical | No | April 2026 |
| AOD-9604 | Not Approved | N/A | N/A | Phase 2 completed (obesity, failed primary endpoint) | No | April 2026 |
| Dihexa | Not Approved | N/A | N/A | No registered trials | No | April 2026 |
| SS-31 (Elamipretide) | In Clinical Trials | N/A (Investigational) | N/A | Phase 3 (Barth syndrome, mitochondrial myopathy) | No | April 2026 |
| NAD+ | Not Approved as Drug | N/A (Supplement/Coenzyme) | N/A | Multiple trials for precursors (NMN, NR) | No | April 2026 |
| Pentosan Polysulfate | FDA-Approved | Interstitial Cystitis | Elmiron | N/A | No | April 2026 |
Understanding FDA Status Categories
- FDA-Approved
- Compounds that have successfully completed the FDA approval process for one or more specific indications. FDA approval means the compound has been studied in clinical trials and determined to be safe and effective for the labeled indication. Important note: approval for one indication does not mean approval for all uses or indications.
- In Clinical Trials
- Compounds that are currently being studied in registered clinical trials (Phase 1, 2, or 3) but have not yet received FDA approval. These compounds are investigational and are not available by prescription for the general public, though qualified patients may access them through clinical trial enrollment or expanded access programs.
- Not FDA-Approved
- Compounds that do not have FDA approval for any indication. This may mean they have never been tested in human clinical trials, testing was discontinued, or trials did not meet regulatory requirements. Many peptides in research do not have formal FDA approval pathways.
- Category 2 Listed
- Compounds added to the FDA's Demonstrably Difficult to Compound list. These compounds cannot be compounded by pharmacies under 503A or 503B pathways. Category 2 status restricts the legal sources through which these peptides can be obtained and has significant implications for availability in clinical and research settings.
- Approved Outside US
- Compounds that have been approved by regulatory agencies in other countries (such as the European Medicines Agency, Health Canada, or regulatory bodies in Russia or other nations) but have not received FDA approval in the United States. Approval outside the US does not equate to US FDA approval.
What is the FDA Category 2 List?
Updated April 2026: The FDA's Demonstrably Difficult to Compound (Category 2) list identifies active pharmaceutical ingredients and finished drug products that are difficult to compound and do not meet the requirements for compounding. Peptides added to Category 2 cannot be legally compounded by pharmacies under the 503A (traditional) or 503B (outsourcing) compounding pathways.
When a peptide is Category 2 listed, it means that either the FDA has determined the compound cannot be safely or effectively compounded from bulk ingredients, or the compound is already approved as a manufactured drug and compounding would constitute circumventing FDA approval requirements. For peptides on this site, Category 2 designation significantly impacts their availability, as they cannot be obtained through standard pharmacy compounding channels.
For current information on the Category 2 list, refer directly to FDA.gov's compounding guidance and the official Demonstrably Difficult to Compound list, which is updated regularly.
Clinical Trial Resources
To verify the status of clinical trials and regulatory information mentioned on this page, refer to these authoritative sources:
ClinicalTrials.gov
The official U.S. registry of clinical studies. Search for any peptide to find registered trials and trial status information.
Visit ClinicalTrials.gov →FDA Drug Approvals
FDA's official database of approved drugs, including detailed approval information and labeled indications.
FDA Approval Database →FDA Orange Book
The official list of FDA-approved drugs. Use this to confirm approval status and brand names.
FDA Orange Book →FDA Compounding Guidance
Official FDA guidance on pharmacy compounding, including the Demonstrably Difficult to Compound list.
Compounding Guidance →DISCLAIMER: FDA status information on this page is compiled from publicly available data sources including FDA.gov, ClinicalTrials.gov, regulatory agency databases, and manufacturer disclosures. While we strive for accuracy, regulatory status changes frequently. Status information may change without notice, and this page cannot guarantee real-time accuracy of all entries. Always verify current FDA status directly through official FDA sources before making any decisions related to therapeutic use, clinical research participation, or legal status. Last comprehensive review: April 2026. This page is for educational and informational purposes only and does not constitute medical advice.