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PT-141 clinical trials

ClinicalTrials.gov lists 10 registered trials of PT-141: 0 recruiting or about to, 1 running, 9 completed, 3 in phase 3, 4 with results posted. The largest is 1. Study to Evaluate the Efficacy/Safety of Bremelanotide in Premenopausal Women With Hypoactive Sexual Desire Disorder (723 people).

10registered trials

0recruiting now

1running

9completed

3in phase 3

4with results posted

Running: 1Completed: 910trials
  • Running 1
  • Completed 9

Where PT-141 is in testing

Registered trials by phase. Phase 3 trials are the large ones that decide approval.

0Early phase 1First doses in people
1Phase 1Safety and dosing
4Phase 2Does it work?
3Phase 3Large confirmatory trials
2Phase 4After approval
0Not phasedObservational and other

Timeline

Each bar runs from a trial's start to its planned end; faded bars have no end date. Click a bar to open the trial.

20062008201020122014201620182020202220242026Single Dose of Vyleesi in Lactating Female Subjects to Measure the Concentration of Bremelanotide in Breast Milk · Completed · Phase 4 · 10 people · 2025-07-11 to 2025-11-15A Phase 2 Study Evaluating the Co-Administration of Bremelanotide With Tirzepatide for the Treatment of Obesity · Running · Phase 2 · 108 people · 2024-08-05 to 2025-02-05A Phase IIb, Multicenter, Open-Label, Prospective Study of Bremelanotide in Diabetic Kidney Disease · Completed · Phase 2 · 16 people · 2022-12-26 to 2024-04-26A 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) · Completed · Phase 3 · 193 people · 2021-05-10 to 2023-05-16Role of the Melanocortin-4 Receptor in Hypoactive Sexual Desire Disorder · Completed · Phase 4 · 40 people · 2019-10-07 to 2020-10-06Study to Evaluate Rate of Nausea in Healthy Premenopausal Female Subjects Treated With Single Dose of Bremelanotide Alone or With Zofran · Completed · Phase 1 · 228 people · 2019-06-17 to 2019-07-192. Study to Evaluate the Efficacy/Safety of Bremelanotide in Premenopausal Women With Hypoactive Sexual Desire Disorder · Completed · Phase 3 · 714 people · 2015-01 to 2016-081. Study to Evaluate the Efficacy/Safety of Bremelanotide in Premenopausal Women With Hypoactive Sexual Desire Disorder · Completed · Phase 3 · 723 people · 2014-12 to 2016-07Bremelanotide in Premenopausal Women With Female Sexual Arousal Disorder and/or Hypoactive Sexual Desire Disorder · Completed · Phase 2 · 612 people · 2011-06 to 2012-09Evaluate the Safety and Efficacy of Bremelanotide in Women With Female Sexual Arousal Disorder (FSAD) · Completed · Phase 2 · 2006-02 to 2007-05
RecruitingRunningCompletedStopped or withdrawnStatus unknownToday

Active, not recruiting 1

A Phase 2 Study Evaluating the Co-Administration of Bremelanotide With Tirzepatide for the Treatment of Obesity

Active, not recruitingPhase 2108 peopleRandomizedPalatin Technologies, Inc2024-08-05 → 2025-02-05🇺🇸 United States

Studying: Obesity · NCT06565611

About this trial

This is a prospective, randomized, double-blind, placebo-controlled study designed to assess the safety and efficacy of bremelanotide (BMT) used in combination with tirzepatide therapy in the treatment of obesity in subjects with a BMI ranging from 30.0 to 45.0 kg/m2 (inclusive).

Completed 9

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

CompletedPhase 3723 peopleRandomizedPalatin Technologies, Inc2014-12 → 2016-07🇨🇦🇺🇸 Canada, United StatesResults posted

Studying: Hypoactive Sexual Desire Disorder · NCT02333071

About this trial

A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group Trial with an optional Open-label Extension to evaluate the efficacy of bremelanotide (BMT), administered subcutaneously (SC) on an as needed basis for the treatment of HSDD (with or without decreased arousal) in premenopausal females.

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

CompletedPhase 3714 peopleRandomizedPalatin Technologies, Inc2015-01 → 2016-08🇨🇦🇺🇸 Canada, United StatesResults posted

Studying: Hypoactive Sexual Desire Disorder · NCT02338960

About this trial

A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group Trial with an optional Open-label Extension to evaluate the efficacy of bremelanotide (BMT), administered subcutaneously (SC) on an as needed basis for the treatment of HSDD (with or without decreased arousal) in premenopausal females.

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

CompletedPhase 2612 peopleRandomizedPalatin Technologies, Inc2011-06 → 2012-09🇨🇦🇺🇸 Canada, United StatesResults posted

Studying: Female Sexual Arousal Disorder, Hypoactive Sexual Desire Disorder · NCT01382719

About this trial

This trial is designed to evaluate the efficacy and safety of 3 fixed dose levels of bremelanotide, administered subcutaneously on an as-needed basis under conditions of home use, for the treatment of female sexual arousal disorder (FSAD), hypoactive sexual desire disorder (HSDD), or mixed FSAD/HSDD in premenopausal women.

Role of the Melanocortin-4 Receptor in Hypoactive Sexual Desire Disorder

CompletedPhase 440 peopleRandomizedImperial College Healthcare NHS Trust2019-10-07 → 2020-10-06🇬🇧 United KingdomResults posted

Studying: Hypoactive Sexual Desire Disorder · NCT04179734

About this trial

A randomised, double-blind, placebo-controlled, two-way crossover physiological study. Designed to evaluate the effects of melanocortin-4 receptor (MC4R) activation on brain activity patterns and behavioural psychometric measures of sexual arousal during visual erotic stimuli in approximately 40 right-handed, heterosexual, premenopausal women aged 18 years and over with Hypoactive Sexual Desire Disorder (HSDD) for at least a 6 month duration.

Study to Evaluate Rate of Nausea in Healthy Premenopausal Female Subjects Treated With Single Dose of Bremelanotide Alone or With Zofran

CompletedPhase 1228 peopleRandomizedAMAG Pharmaceuticals, Inc.2019-06-17 → 2019-07-19🇺🇸 United States

Studying: Nausea · NCT03973047

About this trial

This is a Phase 1, randomized study to evaluate the rate of nausea in healthy premenopausal study participants following a single dose of BMT with or without a single 8 mg po dose of Zofran given 30 minutes before BMT dosing.

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)

CompletedPhase 3193 peopleRandomizedKwang Dong Pharmaceutical co., ltd.2021-05-10 → 2023-05-16🇰🇷 South Korea

Studying: Hypoactive Sexual Desire Disorder · NCT04943068

About this trial

The purpose of this study is to Evaluate the Efficacy and Safety of Subcutaneously Administered Bremelanotide in Premenopausal Women with Hypoactive Sexual Desire Disorder(with or without Decreased Arousal).

A Phase IIb, Multicenter, Open-Label, Prospective Study of Bremelanotide in Diabetic Kidney Disease

CompletedPhase 216 peoplePalatin Technologies, Inc2022-12-26 → 2024-04-26🇺🇸 United States

Studying: Kidney Disease · NCT05709444

About this trial

This is a prospective, open-label trial to assess the efficacy of melanocortin receptor agonist bremelanotide (BMT) when administered with RAAS inhibition therapy after six months in subjects with Type II diabetic nephropathy. After six months of therapy, all subjects will remain in trial for further assessment and undergo a diagnostic renal biopsy to assess the effect of melanocortin therapy on diabetic histopathology at 12 months.

Single Dose of Vyleesi in Lactating Female Subjects to Measure the Concentration of Bremelanotide in Breast Milk

CompletedPhase 410 peopleCosette Pharmaceuticals, Inc.2025-07-11 → 2025-11-15🇺🇸 United States

Studying: Lactating Mother · NCT06867835

About this trial

The primary objectives of this clinical trial performed with Vyleesi (Bremelanotide Injection) are: * to evaluate if Bremelanotide (BMT) is secreted in breast milk of lactating women treated with a single dose of BMT 1.75 mg SC. * to measure the concentration and characterize the pharmacokinetics of BMT secreted in breast milk of lactating women treated with a single dose of BMT 1.75 mg SC. This open-label, pharmacokinetic (PK) study will be performed in 10 healthy lactating female subjects between 10 days and 6 months post-partum (inclusive). The maximum duration of subject participation in…

Registered trials include ones that haven't published results yet. Trials are matched on the compound's name and code names (PT-141, bremelanotide) in the listed interventions.