# PT-141

PT-141 has 10 registered human trials. It is marketed for 3 different uses.

**In short**

- 10 registered human trials exist for PT-141.
- PT-141 is FDA-approved — FDA-approved as Vyleesi for hypoactive sexual desire disorder in premenopausal women. Grey-market "PT-141" is not the approved product..
- What has actually been studied: sexual arousal disorder, hypoactive sexual desire disorder, lactating mother.
- Last checked against ClinicalTrials.gov on 2026-07-27.

## What it is sold for

- Libido / sexual function
- Erectile function
- Energy

## What has actually been tested

- Sexual Arousal Disorder
- Hypoactive Sexual Desire Disorder
- Lactating Mother
- Female Sexual Arousal Disorder
- Nausea
- Kidney Disease
- Obesity

## Every trial on record

| Trial ID | Title | Condition | Phase | Status | Enrolled |
|---|---|---|---|---|---|
| [NCT00425256](https://clinicaltrials.gov/study/NCT00425256) | Evaluate the Safety and Efficacy of Bremelanotide in Women With Female Sexual Arousal Disorder (FSAD) | Sexual Arousal Disorder | Phase 2 | COMPLETED | — |
| [NCT04943068](https://clinicaltrials.gov/study/NCT04943068) | A Phase 3, Bridging, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Trial to Evaluate the Efficacy and Safety of Subcutaneously Administered Bremelanotide in Premenopausal Women With Hypoactive Sexual Desire Disorder (With or Without Decreased Arousal) | Hypoactive Sexual Desire Disorder | Phase 3 | COMPLETED | 193 |
| [NCT06867835](https://clinicaltrials.gov/study/NCT06867835) | Single Dose of Vyleesi in Lactating Female Subjects to Measure the Concentration of Bremelanotide in Breast Milk | Lactating Mother | Phase 4 | COMPLETED | 10 |
| [NCT02338960](https://clinicaltrials.gov/study/NCT02338960) | 2. Study to Evaluate the Efficacy/Safety of Bremelanotide in Premenopausal Women With Hypoactive Sexual Desire Disorder | Hypoactive Sexual Desire Disorder | Phase 3 | COMPLETED | 714 |
| [NCT01382719](https://clinicaltrials.gov/study/NCT01382719) | Bremelanotide in Premenopausal Women With Female Sexual Arousal Disorder and/or Hypoactive Sexual Desire Disorder | Female Sexual Arousal Disorder, Hypoactive Sexual Desire Disorder | Phase 2 | COMPLETED | 612 |
| [NCT03973047](https://clinicaltrials.gov/study/NCT03973047) | Study to Evaluate Rate of Nausea in Healthy Premenopausal Female Subjects Treated With Single Dose of Bremelanotide Alone or With Zofran | Nausea | Phase 1 | COMPLETED | 228 |
| [NCT02333071](https://clinicaltrials.gov/study/NCT02333071) | 1. Study to Evaluate the Efficacy/Safety of Bremelanotide in Premenopausal Women With Hypoactive Sexual Desire Disorder | Hypoactive Sexual Desire Disorder | Phase 3 | COMPLETED | 723 |
| [NCT05709444](https://clinicaltrials.gov/study/NCT05709444) | A Phase IIb, Multicenter, Open-Label, Prospective Study of Bremelanotide in Diabetic Kidney Disease | Kidney Disease | Phase 2 | COMPLETED | 16 |
| [NCT06565611](https://clinicaltrials.gov/study/NCT06565611) | A Phase 2 Study Evaluating the Co-Administration of Bremelanotide With Tirzepatide for the Treatment of Obesity | Obesity | Phase 2 | ACTIVE_NOT_RECRUITING | 108 |
| [NCT04179734](https://clinicaltrials.gov/study/NCT04179734) | Role of the Melanocortin-4 Receptor in Hypoactive Sexual Desire Disorder | Hypoactive Sexual Desire Disorder | Phase 4 | COMPLETED | 40 |

## Common questions

**How many human trials does PT-141 have?**
10, each listed above with a link to its original record.

**Is PT-141 FDA approved?**
Yes — FDA-approved as Vyleesi for hypoactive sexual desire disorder in premenopausal women. Grey-market "PT-141" is not the approved product.

**Where does this data come from?**
ClinicalTrials.gov. We count interventional human studies only. Every trial
links to its original record.

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*Automated aggregation from public registries. Not medical advice. No physician
has reviewed this page. Source: https://www.whatsactuallyknown.com/compounds/pt-141*