Human RCT-level evidence

PT-141

What the research and the regulators actually say, sourced to primary documents.

Studies indexed
0
Clinical trials
0
Last updated
July 23, 2026

Updated · sourced to primary documents

Research information only, not medical advice. Bremelanotide (PT-141) is an FDA-approved drug — Vyleesi, initial U.S. approval 2019 — for acquired, generalized hypoactive sexual desire disorder (HSDD) in premenopausal women. It is a melanocortin receptor agonist (nonselective, MC1R and MC4R most relevant at therapeutic doses), given as a 1.75 mg subcutaneous self-injection at least 45 minutes before anticipated sexual activity; the precise mechanism by which it improves HSDD is unknown. It is contraindicated in uncontrolled hypertension or known cardiovascular disease.

PT-141 at a glance

The evidence base supporting the 2019 FDA approval consists of two identical phase 3 randomized, double-blind, placebo-controlled trials (RECONNECT studies 301 and 302; 1,267 premenopausal women over 24 weeks). Bremelanotide produced statistically significant but small increases in the FSFI desire-domain score (integrated change 0.35, P<.001) and reductions in desire-related distress (Kingsberg et al., Obstetrics & Gynecology 2019, PMID 31599840). The most common adverse reactions are nausea (40%), flushing (20%), injection-site reactions (13%), and headache (11%). Each dose causes a transient increase in blood pressure and decrease in heart rate, generally resolving within 12 hours. Focal hyperpigmentation was reported in 1% of patients receiving up to 8 doses/month versus 0% on placebo and may not fully resolve after discontinuation. Bremelanotide is an FDA-approved drug, not investigational.

See how we grade evidence for the methodology behind this page.

Evidence profile

61 studies
  • Human RCT 4 · 7%
  • Human trial 3 · 5%
  • Review 38 · 62%
  • Animal 4 · 7%
  • In-vitro 4 · 7%
  • Unknown 8 · 13%

The longer the green, the stronger the human evidence. For most research peptides the bar is dominated by animal and in-vitro work, which is a signal to read every claim carefully.

Regulatory status

Clinical trials

  • NCT01382719 PHASE2 COMPLETED

    Bremelanotide in Premenopausal Women With Female Sexual Arousal Disorder and/or Hypoactive Sexual Desire Disorder

  • NCT02333071 PHASE3 COMPLETED

    1. Study to Evaluate the Efficacy/Safety of Bremelanotide in Premenopausal Women With Hypoactive Sexual Desire Disorder

  • NCT02338960 PHASE3 COMPLETED

    2. Study to Evaluate the Efficacy/Safety of Bremelanotide in Premenopausal Women With Hypoactive Sexual Desire Disorder

Indexed research

Sorted by evidence level, strongest first.

+ 51 more studies indexed for PT-141.

Frequently asked questions

Is PT-141 approved for human use?
Bremelanotide (PT-141) is an FDA-approved drug — Vyleesi, initial U.S. approval 2019 — for acquired, generalized hypoactive sexual desire disorder (HSDD) in premenopausal women. It is a melanocortin receptor agonist (nonselective, MC1R and MC4R most relevant at therapeutic doses), given as a 1.75 mg subcutaneous self-injection at least 45 minutes before anticipated sexual activity; the precise mechanism by which it improves HSDD is unknown. It is contraindicated in uncontrolled hypertension or known cardiovascular disease.
What does the research on PT-141 show?
The evidence base supporting the 2019 FDA approval consists of two identical phase 3 randomized, double-blind, placebo-controlled trials (RECONNECT studies 301 and 302; 1,267 premenopausal women over 24 weeks). Bremelanotide produced statistically significant but small increases in the FSFI desire-domain score (integrated change 0.35, P<.001) and reductions in desire-related distress (Kingsberg et al., Obstetrics & Gynecology 2019, PMID 31599840). The most common adverse reactions are nausea (40%), flushing (20%), injection-site reactions (13%), and headache (11%). Each dose causes a transient increase in blood pressure and decrease in heart rate, generally resolving within 12 hours. Focal hyperpigmentation was reported in 1% of patients receiving up to 8 doses/month versus 0% on placebo and may not fully resolve after discontinuation. Bremelanotide is an FDA-approved drug, not investigational.