PT-141: what was approved, and who it was approved for
PT-141 is one of the few peptides on a telehealth menu with a real FDA approval behind it. The catch is who that approval covers. Vyleesi was approved in June 2019 for premenopausal women with low sexual desire, and its label rules out men and rules out use for enhancing performance, in as many words. A compounded vial carries none of that.
What this comes down to
- Bremelanotide is approved as Vyleesi, a 1.75 mg autoinjector, for premenopausal women with acquired, generalized hypoactive sexual desire disorder. That's the whole approval.
- The label's own limitations section rules out postmenopausal women, rules out men, and rules out use for performance.
- The two trials behind the approval moved desire by about a third of a point on a five-point scale. A published reanalysis of the same data found participants preferred placebo.
- Because bremelanotide is the active ingredient of an approved product, a compounding pharmacy has a lawful route to the bulk substance — which isn't true of most peptides on these menus.
What the FDA actually approved
One application, NDA 210557, approved June 21, 2019. One product: a prefilled autoinjector delivering 1.75 mg of bremelanotide under the skin of the abdomen or thigh, taken as needed at least 45 minutes ahead[2]. The label caps it at one dose in 24 hours and says more than eight doses a month is not recommended[1].
“VYLEESI is not indicated for the treatment of HSDD in postmenopausal women or in men. VYLEESI is not indicated to enhance sexual performance.”
[1]
A limitation of use isn't a formality. It means the trials behind the approval didn't enroll those people, so nothing about how well it works in them was ever established. Every compounded PT-141 program aimed at men sits outside it.
How well it worked in the people it was tested on
Two identical 24-week trials, 1,267 women randomized, both placebo-controlled. Desire on the Female Sexual Function Index rose 0.35 points more than placebo across the integrated studies, and distress about low desire fell 0.33 points more[3]. Both were statistically significant. Both are small numbers on scales that run to five and four.
A 2021 reanalysis in the Journal of Sex Research went back to the FDA new drug application. It reported that 72.72% of the outcomes listed in the study protocols were not reported in the published paper, that dropping out because of a side effect was far more common on the drug, and that by a combined measure of finishing the trial and electing into the open-label extension, participants preferred placebo[4].
PubMed, via the E-utilities API
("bremelanotide"[tiab] OR "PT-141"[tiab] OR "PT 141"[tiab]) AND "randomized controlled trial"[pt] AND "humans"[mh]Returned 14. Positive control — semaglutide, identical filter — returned 312 through the identical filter in the same session.
Fourteen is a real record, not an empty one. Four of the 14 concern men, and all four ran between 2004 and 2008 — years before the product that was eventually approved existed.
The side effects the label leads with
- Nausea in 40% of patients taking up to eight doses a month, needing anti-nausea medicine in 13% and ending treatment for 8%[1].
- A transient blood pressure rise after every dose, peaking two to four hours later and usually settling within twelve. The drug is contraindicated in anyone with uncontrolled hypertension or known cardiovascular disease.
- Focal hyperpigmentation in 1% of patients, including on the face, gums and breasts, more likely with darker skin and with daily dosing. It didn't always resolve.
- 18% of patients on the drug stopped because of a side effect, against 2% on placebo.
The eight-doses-a-month ceiling and the blood pressure contraindication come off an approved label. A compounded preparation carries whatever its compounder wrote. Ask which one you're getting before the first injection, not after.
What is legal about the compounded version
A pharmacy compounding under section 503A can only use a bulk substance that meets a USP or National Formulary monograph, or is a component of an FDA-approved drug product, or sits on the FDA's 503A bulks list[5]. Bremelanotide is the active ingredient of Vyleesi, so the second condition is met. That's a materially better position than BPC-157, which meets none of the three.
The FDA also keeps a public page of substances it has flagged as presenting significant safety risks in compounding, with the safety text it wrote beside each name[6]. Bremelanotide is not on it. That absence is only worth reporting because a name that's on the page — ipamorelin — was searched in the same read and found.
The FDA category-2 compounding page, full text read the same day
full-text search of the page for "bremelanotide" and "PT-141"
Returned 0. Positive control — ipamorelin, same page, same read — returned 6 through the identical filter in the same session.
The page carries two tables — substances currently in category 2, and substances whose nomination was withdrawn. Ipamorelin, BPC-157 and GHK-Cu all appear on it. Bremelanotide appears on neither table, which is a point in its favor and is stated as one.
What it costs on the companies we have priced
Four sellers on our roster publish a PT-141 price, and the spread runs from $79 to $270 a month. Same molecule, same compounded status, a 3.4-times gap. The listing at the bottom of that range, from WePeptideRx, is priced as a combined PT-141 and PDE5 program rather than as the peptide on its own.
| Seller | What it is called | A month |
|---|---|---|
| WePeptideRx | PT-141 and PDE5 programs | $79 |
| TRT Kingdom | PT-141 | $89 |
| iThriveMD | PT-141 | $199 |
| LifespanningRx | PT-141 | $270 |
PT-141 prices on the sellers we have read first-hand
None of those figures includes a membership, where the seller charges one. We keep the two apart on the cost calculator for the same reason the sellers don't, and what a membership buys is its own question.
Questions people actually ask
Is PT-141 the same thing as Vyleesi?
Same active ingredient, different product. Vyleesi is an FDA-approved autoinjector holding a fixed 1.75 mg dose, reviewed for safety, effectiveness and manufacturing quality. Compounded PT-141 is made to a prescription by a pharmacy and isn't reviewed by the FDA before it's sold.
Is PT-141 approved for men?
No. The Vyleesi label's limitations of use say plainly that it is not indicated for HSDD in men and not indicated to enhance sexual performance. Studies in men exist, but they're dose-finding and safety work from 2004 to 2008 on earlier formulations, not evidence that supported an approval.
Why do PT-141 prices vary so much between telehealth companies?
The sellers we have priced run from $79 to $270 a month for the same compounded peptide. Some of that is dose and vial size, some of it's what else is bundled in, and some of it's simply what the company decided to charge. There's no reference price for a compounded drug.
Does PT-141 raise blood pressure?
The approved product does, transiently, after every dose — maximal increases of 6 mmHg systolic and 3 mmHg diastolic in the clinical studies, peaking two to four hours after the injection. That's why it's contraindicated in people with uncontrolled hypertension or known cardiovascular disease.
Sources
Every source here was fetched and read for this article, with the identifier taken off the record that came back and the claim it supports written down beside it. All of it was read in September 2026, the same session the rest of this page draws on.
- VYLEESI (bremelanotide) injection, for subcutaneous use — FDA prescribing information. U.S. Food and Drug Administration, Structured Product Labeling, 2025. Source · Document dated November 2025Indication limited to premenopausal women with acquired, generalized HSDD; the limitations of use excluding men, postmenopausal women and performance; the 1.75 mg dose and eight-dose monthly ceiling; the contraindication in uncontrolled hypertension or known cardiovascular disease; nausea in 40%; 18% versus 2% discontinuation; 1% focal hyperpigmentation.
- Drugs@FDA: FDA-Approved Drugs, queried through the openFDA API. U.S. Food and Drug Administration, 2026. Source · Bremelanotide resolves to exactly one application, NDA 210557, original submission approved June 21, 2019, as the Vyleesi autoinjector. A deliberately fake ingredient name returned an empty result on the same endpoint in the same session, and tesamorelin returned one application, so an empty result on this API means something.
- Bremelanotide for the Treatment of Hypoactive Sexual Desire Disorder: Two Randomized Phase 3 Trials. Obstetrics & Gynecology, 2019. PMID 31599840 · doi:10.1097/AOG.0000000000003500 · The two 24-week RECONNECT trials, 1,267 women randomized, and the integrated results: desire +0.35 and distress −0.33 against placebo, both p<.001, with nausea, flushing and headache each reported by 10% or more.
- Re-Analyzing Phase III Bremelanotide Trials for "Hypoactive Sexual Desire Disorder" in Women. The Journal of Sex Research, 2021. PMID 33678061 · doi:10.1080/00224499.2021.1885601 · 72.72% of protocol-listed outcomes went unreported; adverse-event-induced discontinuation was substantially higher on bremelanotide; and by a combined measure of trial completion and entry into the open-label extension, participants preferred placebo.
- Bulk Drug Substances Used in Compounding Under Section 503A of the FD&C Act. U.S. Food and Drug Administration, 2026. Source · Document dated May 2026The three conditions a bulk substance must meet to be used by a 503A compounder: a USP or NF monograph, or being a component of an FDA-approved drug product, or appearing on the 503A bulks list.
- Substances in Compounding that May Present Significant Safety Risks. U.S. Food and Drug Administration, 2026. Source · Document dated April 2026Bremelanotide and PT-141 appear nowhere on the category-2 page, on either the live table or the withdrawn one, while ipamorelin appears six times on the same read.