US status

Approved

By Peptide America · Publisher · Reviewed September 2026

An FDA approval means a specific product completed clinical development: controlled trials in a named indication, a reviewed manufacturing process, and labeling that states what the evidence supports. The approval belongs to the product and its indication, not to the molecule in every use a seller can imagine for it.

The molecules listed below hold approvals; the count is whatever the table shows, and it changes as the index grows. For each, the approved product is the lawful supply route; under section 503A, a pharmacy may not compound what is essentially a copy of a commercially available drug unless a prescriber documents a clinical difference for an individual patient, and the FDA has rejected price as such a difference. An approval is also narrower than it sounds: it attaches to a product in a stated indication, and several of the labels here carry limitations of use that exclude the populations the compound is most often sold to.

Molecules holding this status

Molecule	Class	US status	Position
TesamorelinEGRIFTA; GHRH(1–44) analogue	GH secretagogues	FDA-approved	Approved since 2010; EGRIFTA WR (weekly reconstitution) approved March 2025. Verified August 2026.
SemaglutideOzempic; Wegovy; Rybelsus	GLP-1 receptor agonists	FDA-approved	Approved brand products; mass compounding ended after the shortage resolved; narrow patient-specific 503A path remains. Verified August 2026.
TirzepatideMounjaro; Zepbound	GLP-1 receptor agonists	FDA-approved	Approved brand products; shortage resolved October 2024; same narrow 503A posture as semaglutide. Verified August 2026.
SetmelanotideRM-493; Imcivree	Melanocortins	FDA-approved	Approved November 2020 as Imcivree for rare genetic and acquired hypothalamic obesity; the label states it is not indicated for general obesity.
PT-141Bremelanotide; Vyleesi	Melanocortins	FDA-approved	Approved June 2019 as Vyleesi for one narrowly defined indication in premenopausal women; the label states it is not indicated for men. Verified August 2026.
LiraglutideVictoza; Saxenda	GLP-1 receptor agonists	FDA-approved	Approved since 2010, generic since 2024, and still listed as in shortage — the only molecule in this index whose supply problem is unresolved. Verified August 2026.
SecretinSynthetic human secretin; ChiRhoStim	Gut peptides	FDA-approved	An approved diagnostic drug since 2004, and separately a bulk substance nominated to the 503A list without adequate support; the nomination sits in Category 3.
ElamipretideSS-31; MTP-131; Forzinity	Mitochondrial	FDA-approved	Approved September 2025 as Forzinity under accelerated approval for Barth syndrome; the only approved product in this index's mitochondrial group.
AfamelanotideMelanotan-I; Scenesse; CUV1647	Melanocortins	FDA-approved	Approved October 2019 as Scenesse for one rare photodermatosis; the pre-approval literature calls the same compound melanotan-I.
DulaglutideTrulicity; LY2189265	GLP-1 receptor agonists	FDA-approved	Licensed September 2014 as Trulicity for type 2 diabetes and cardiovascular risk; the current label carries no weight-management indication.

TesamorelinFDA-approved
EGRIFTA; GHRH(1–44) analogue
Approved since 2010; EGRIFTA WR (weekly reconstitution) approved March 2025. Verified August 2026.
SemaglutideFDA-approved
Ozempic; Wegovy; Rybelsus
Approved brand products; mass compounding ended after the shortage resolved; narrow patient-specific 503A path remains. Verified August 2026.
TirzepatideFDA-approved
Mounjaro; Zepbound
Approved brand products; shortage resolved October 2024; same narrow 503A posture as semaglutide. Verified August 2026.
SetmelanotideFDA-approved
RM-493; Imcivree
Approved November 2020 as Imcivree for rare genetic and acquired hypothalamic obesity; the label states it is not indicated for general obesity.
PT-141FDA-approved
Bremelanotide; Vyleesi
Approved June 2019 as Vyleesi for one narrowly defined indication in premenopausal women; the label states it is not indicated for men. Verified August 2026.
LiraglutideFDA-approved
Victoza; Saxenda
Approved since 2010, generic since 2024, and still listed as in shortage — the only molecule in this index whose supply problem is unresolved. Verified August 2026.
SecretinFDA-approved
Synthetic human secretin; ChiRhoStim
An approved diagnostic drug since 2004, and separately a bulk substance nominated to the 503A list without adequate support; the nomination sits in Category 3.
ElamipretideFDA-approved
SS-31; MTP-131; Forzinity
Approved September 2025 as Forzinity under accelerated approval for Barth syndrome; the only approved product in this index's mitochondrial group.
AfamelanotideFDA-approved
Melanotan-I; Scenesse; CUV1647
Approved October 2019 as Scenesse for one rare photodermatosis; the pre-approval literature calls the same compound melanotan-I.
DulaglutideFDA-approved
Trulicity; LY2189265
Licensed September 2014 as Trulicity for type 2 diabetes and cardiovascular risk; the current label carries no weight-management indication.

The monographs above carry each product's record and its trial evidence; the compoundable page covers the molecules a pharmacy may prepare without an approved product behind them.

Elsewhere in this index

Evidence reviews

Peptides for Weight Loss, by US Legal StatusWhich peptides sold for weight loss are actually FDA-approved for it?
Sermorelin vs Tesamorelin: How They DifferHow do sermorelin and tesamorelin differ?
Tesamorelin Side Effects: What the Label SaysWhat side effects does the tesamorelin label record?
Tesamorelin: Approved Drug, Sold PeptideDoes the evidence behind tesamorelin's approval support general fat loss?
Semaglutide Withdrawal: Weight Regain EvidenceHow much weight returns after stopping semaglutide?
Dulaglutide vs Semaglutide: Trial ResultsWhat does the dulaglutide-versus-semaglutide evidence actually compare?
Incretin Pipeline: Retatrutide and CagriSemaWhich incretin drugs are approved, which are still in trials, and which of them are peptides?
Tirzepatide: Sleep Apnea Trial EvidenceDoes tirzepatide treat sleep apnea or only reduce weight?
Setmelanotide: Who Lost Weight in Trials?Can setmelanotide trial results predict general weight loss?
Bremelanotide: Desire and Distress TrialsWhat did bremelanotide improve in the RECONNECT trials?
PT-141: The Approval Buyers Do Not Know AboutWhat is PT-141's actual United States posture, and what does its approval cover?
Category 3: Nominated, Not ReviewedWhat does Category 3 of the FDA 503A bulks list actually mean?
Secretin for Autism: A Closed QuestionDid the randomized trials of secretin for autism support the treatment?
Elamipretide for Fatigue: Trial ResultsDoes elamipretide improve fatigue and exercise capacity?
Afamelanotide: Light Tolerance EvidenceWhat did afamelanotide trials actually measure?
Melanotan I vs II: One Approved, One NotWhat is the difference between Melanotan I and Melanotan II?
Retatrutide and Lean Mass: Trial EvidenceDoes retatrutide preserve muscle while reducing body fat?

Reference tables

The 2026 recordWhat happened to United States peptide compounding law in 2026, in order?
The nomination trackerWhat became of each peptide's nomination to the 503A bulks list?
Approved peptide drugsWhich peptides in this index are actually approved drugs?
The human trial record, by moleculeHow many human clinical trials exist for each peptide in this index?
The WADA Prohibited ListWhich peptides in this index are prohibited in sport, and under which class?

Definitions

Section 503AThe provision under which a licensed pharmacy compounds a drug for an individual patient with a valid prescription.
Documented clinical needThe standard a prescriber must meet to compound a copy of an approved drug. The FDA has rejected price as satisfying it.
Essentially a copyA compounded preparation duplicating a commercially available approved drug, which section 503A restricts.
All glossary terms