Which peptides are actually FDA-approved in 2026? This tracker separates approved agents from compounded, Category 2, and PCAC-pending substances — with classifications subject to change as the July 2026 PCAC meeting approaches.
Last updated: July 17, 2026
Search results on FDA-approved peptides are inconsistent, and much of what ranks comes from vendor pages with a financial reason to blur the line between “approved” and “available.” This tracker draws that line: which peptides carry genuine FDA approval, which are compounded or flagged on the FDA’s safety-risk list, which are still investigational, and what’s pending at the Pharmacy Compounding Advisory Committee (PCAC) meeting on July 23–24, 2026. Classifications shift, so this is a living page, date-stamped now and scheduled for re-publication once the PCAC outcome and any Category 1/2 changes are confirmed.
In This Article
FDA-Approved Peptides (2026)
The list of peptides with genuine FDA approval is short, and each approval is tied to a specific product and indication, not a molecule in the abstract. Insulin analogs remain approved for diabetes. Semaglutide and tirzepatide are approved for type 2 diabetes and, under different brand names, for weight management. Tesamorelin (Egrifta) is approved for HIV-associated lipodystrophy. Bremelanotide is approved for hypoactive sexual desire disorder (HSDD).
Product name matters as much as molecule. Zepbound (tirzepatide) is approved for weight management and moderate-to-severe obstructive sleep apnea in patients with obesity, while Mounjaro (also tirzepatide) is approved for type 2 diabetes. Wegovy (semaglutide) covers weight management, Ozempic covers type 2 diabetes. Saxenda and Victoza split liraglutide the same way. A patient asking about “semaglutide” or “tirzepatide” is asking about a specific product with a specific indication, and documentation should reflect that.
| Brand Name | Molecule | FDA-Approved Indication |
|---|---|---|
| Ozempic | Semaglutide | Type 2 diabetes management |
| Wegovy | Semaglutide | Chronic weight management (BMI ≥30, or ≥27 with comorbidity) |
| Mounjaro | Tirzepatide | Type 2 diabetes management |
| Zepbound | Tirzepatide | Chronic weight management; moderate-to-severe OSA in obesity |
| Victoza | Liraglutide | Type 2 diabetes management |
| Saxenda | Liraglutide | Chronic weight management |
| Egrifta / Egrifta SV | Tesamorelin | HIV-associated lipodystrophy |
| Vyleesi | Bremelanotide | Hypoactive sexual desire disorder (HSDD) in premenopausal women |
| Insulin analogs (multiple brands) | Various insulin analogs | Diabetes mellitus (type 1 and type 2) |
Source: Drugs@FDA. Approval tied to specific product and indication — not the molecule generally.
Brand / Molecule
Ozempic — Semaglutide
Type 2 diabetes management
Brand / Molecule
Wegovy — Semaglutide
Chronic weight management (BMI ≥30, or ≥27 with comorbidity)
Brand / Molecule
Mounjaro — Tirzepatide
Type 2 diabetes management
Brand / Molecule
Zepbound — Tirzepatide
Chronic weight management; moderate-to-severe OSA in obesity
Brand / Molecule
Victoza — Liraglutide
Type 2 diabetes management
Brand / Molecule
Saxenda — Liraglutide
Chronic weight management
Brand / Molecule
Egrifta / Egrifta SV — Tesamorelin
HIV-associated lipodystrophy
Brand / Molecule
Vyleesi — Bremelanotide
Hypoactive sexual desire disorder (HSDD) in premenopausal women
Brand / Molecule
Insulin analogs (multiple brands)
Diabetes mellitus (type 1 and type 2)
Compounded & Category 2
Compounded is not a synonym for approved. The FDA does not verify the safety, effectiveness, or quality of compounded drugs before they reach a patient, which shifts that burden onto the prescribing provider. Sermorelin, withdrawn as a branded product in 2008, is now available only through compounding for off-label adult use. CJC-1295 (with or without DAC), ipamorelin, and GHRP-2/GHRP-6 fall into the same compounded category: available through compounding pharmacies, but without FDA approval behind them.
A subset of compounded peptides carries an additional designation. The FDA’s safety-risk list — sometimes called Category 2 — includes BPC-157, CJC-1295, injectable GHK-Cu, ipamorelin acetate, and thymosin beta-4 fragment (TB-500), based on identified concerns including immunogenicity, peptide-related impurities, and limited human safety data. The FDA may consider enforcement action against pharmacies compounding Category 2 substances, so this is a documented regulatory position, not a gray area. For the clinical evidence behind one of these substances, see our full BPC-157 guide.
Compounded (Not Category 2)
Available through 503A/503B compounding; not FDA-approved
Category 2 (FDA Safety-Risk List)
FDA may consider enforcement action for compounding
Reading a regulatory category correctly, and knowing what it does and doesn’t permit, is exactly the judgment call the IAPAM peptide course trains providers to make before a prescribing decision. See the peptide therapy training for how that framework is taught.
Investigational & Unapproved
A third group has no FDA approval and no licensed compounding pathway. MK-677 (ibutamoren) is not legally marketed in the United States. AOD-9604 was studied in a 536-participant obesity trial that failed its primary endpoint, and development was discontinued. Melanotan II, Epithalon, and Semax/Selank have no US approval and no licensed compounding basis. These substances circulate through gray-market channels, and a patient citing them has likely encountered marketing rather than regulatory reality.
Three-Category Regulatory Map (2026)
Category 1 — FDA Approved
Specific product + indication approval
Category 2 — Compounded / Safety-Risk List
Available via compounding; FDA not verified; some with enforcement risk
⚠ = FDA Category 2 safety-risk designation; enforcement possible
Category 3 — Investigational / Unapproved
No FDA approval; no licensed US compounding basis; gray-market only
Classifications subject to change. Verify against Drugs@FDA before prescribing.
Peptide FDA Status 2026: What’s Pending
The nearest inflection point is the PCAC meeting scheduled for July 23–24, 2026 (docket FDA-2025-N-6895), reviewing BPC-157, KPV, TB-500, MOTS-c, DSIP, Semax, and Epitalon for potential 503A Bulks List inclusion or exclusion. Until that meeting concludes and the outcome is confirmed against primary FDA sources, treat these substances as provisional.
Unverified report: A separate report describing roughly 14 of 19 Category 2 substances shifting to Category 1 in February 2026 has circulated but is not verified against a primary FDA source. It is not reflected in the table below and should be treated as reported, developing, and unverified.
GLP-1 compounding has also shifted. The FDA-declared shortages that permitted broader compounding have resolved — tirzepatide on December 19, 2024, semaglutide on February 21, 2025. Separately, the FDA has proposed excluding semaglutide, tirzepatide, and liraglutide from the 503B bulks list. That proposal is not yet final; providers relying on compounded GLP-1 access should track the docket rather than assume the current picture is permanent.
| Substance | Current Status | PCAC / Pending Action | Last Verified |
|---|---|---|---|
| Semaglutide | FDA-approved (Ozempic, Wegovy); shortage resolved Feb 21, 2025 | Proposed 503B bulks exclusion — not final | July 2026 |
| Tirzepatide | FDA-approved (Mounjaro, Zepbound); shortage resolved Dec 19, 2024 | Proposed 503B bulks exclusion — not final | July 2026 |
| Liraglutide | FDA-approved (Victoza, Saxenda) | Proposed 503B bulks exclusion — not final | July 2026 |
| BPC-157 | Category 2 bulk substance; enforcement possible | PCAC review July 23–24, 2026 (503A Bulks List) | July 2026 |
| TB-500 | Category 2 bulk substance; WADA-prohibited | PCAC review July 23–24, 2026 | July 2026 |
| KPV | Compounded; status provisional | PCAC review July 23–24, 2026 | July 2026 |
| MOTS-c | Compounded; status provisional | PCAC review July 23–24, 2026 | July 2026 |
| Semax / Selank | Unapproved; no licensed compounding basis | PCAC review July 23–24, 2026 | July 2026 |
| Epitalon | Unapproved; no licensed compounding basis | PCAC review July 23–24, 2026 | July 2026 |
| DSIP | Compounded; status provisional | PCAC review July 23–24, 2026 | July 2026 |
Semaglutide
FDA-approved; shortage resolved Feb 21, 2025
Proposed 503B bulks exclusion — not final. Last verified July 2026.
Tirzepatide
FDA-approved; shortage resolved Dec 19, 2024
Proposed 503B bulks exclusion — not final. Last verified July 2026.
BPC-157
Category 2; enforcement possible
PCAC review July 23–24, 2026 (503A Bulks List). Last verified July 2026.
TB-500
Category 2; WADA-prohibited
PCAC review July 23–24, 2026. Last verified July 2026.
KPV / MOTS-c / DSIP
Compounded; status provisional
PCAC review July 23–24, 2026. Last verified July 2026.
Semax / Selank / Epitalon
Unapproved; no licensed compounding basis
PCAC review July 23–24, 2026. Last verified July 2026.
Interpreting a moving regulatory picture like this one is the discipline the IAPAM peptide course builds into every module. Our guide to prescribing peptides legally translates this status tracker into a compliant prescribing and documentation workflow.
Verify Before You Prescribe
Every classification on this page can change, and several are scheduled to be revisited within weeks of this update. Before prescribing anything outside the confirmed FDA-approved list, check the FDA’s compounding and Drugs@FDA pages directly rather than relying on a vendor site, a forum, or this article alone.
Key Takeaways
Approved list is short and specific. Insulin analogs, semaglutide, tirzepatide, liraglutide, tesamorelin, and bremelanotide — each tied to a particular product and use.
Compounded ≠ approved. Sermorelin, CJC-1295, ipamorelin, and GHRP-2/6 are compounded, not FDA-approved. Several also sit on the Category 2 safety-risk list with possible enforcement exposure.
Gray-market only. MK-677, AOD-9604, Melanotan II, Epithalon, and Semax/Selank are investigational or unapproved with no legal US marketing or compounding basis.
PCAC July 23–24 is the inflection point. BPC-157, KPV, TB-500, MOTS-c, and related substances are all under review. Track the docket.
GLP-1 compounding has narrowed. Shortages resolved; proposed 503B exclusion for semaglutide, tirzepatide, and liraglutide is pending, not final.
Verify before prescribing. Classifications on this page are subject to change. Check Drugs@FDA directly before any prescribing decision outside the approved list.
Turning a status tracker like this into a defensible prescribing practice is what the IAPAM peptide therapy course is built to teach. For the full picture across evidence, regulation, and practice integration, see our peptide therapy for providers hub.
Frequently Asked Questions
Insulin analogs, semaglutide and tirzepatide (type 2 diabetes and, under separate brand names, weight management), tesamorelin (Egrifta) for HIV-associated lipodystrophy, and bremelanotide for hypoactive sexual desire disorder. Approval applies to specific products and indications, not the molecule generally.
No. BPC-157 is on the FDA’s Category 2 safety-risk list, and it is scheduled for PCAC review on July 23–24, 2026 regarding its 503A Bulks List status. It is not approved and its compounding status is currently provisional. See our full BPC-157 guide for the clinical evidence review.
Compounded peptides are not FDA-approved. The FDA does not verify their safety, effectiveness, or quality before they reach patients. Compounding can be legal depending on the substance and pharmacy licensing (503A/503B), but legal compounding and FDA approval are separate questions.
The Pharmacy Compounding Advisory Committee meets July 23–24, 2026 (docket FDA-2025-N-6895) to review BPC-157, KPV, TB-500, MOTS-c, DSIP, Semax, and Epitalon for potential 503A Bulks List inclusion or exclusion. The outcome will affect whether these substances can be legally compounded going forward.
The FDA-declared shortages that broadened compounding access have resolved (tirzepatide December 19, 2024; semaglutide February 21, 2025). The FDA has proposed excluding semaglutide, tirzepatide, and liraglutide from the 503B bulks list, but that proposal is not yet final. Compounding access is narrower than it was and remains in flux.
Both contain tirzepatide, but they are approved for different indications. Zepbound is approved for weight management and moderate-to-severe obstructive sleep apnea in patients with obesity. Mounjaro is approved for type 2 diabetes. They are not interchangeable from a regulatory or prescribing standpoint.
Go Deeper
Knowing the status of a peptide is step one. The IAPAM peptide course builds the judgment to act on it — evidence appraisal, regulatory compliance, documentation, and patient counseling in one framework.
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