PT-141 Research Timeline: What Published Studies Measured

A chronological record of peer-reviewed PT-141 research — trial types, sample sizes, and measured outcomes. This page summarizes what has been studied, not what users should expect to experience.

Educational content only. This page is compiled from published research for reference and is not medical advice, diagnosis, or treatment. Readers should verify claims against primary sources and consult a qualified healthcare provider before making any health decisions. Full disclaimer.

Total Studies
56
Human
18
Animal
25
Evidence
L5 · FDA Approved

What the Research Actually Measured

Peptide research timelines are often misrepresented online. Claims about "how quickly PT-141works" usually blend anecdotal reports with selective trial data. This page restricts itself to what peer-reviewed studies measured, over what duration, with what sample size, and what the authors concluded. Readers should not infer personal results from these numbers.

Primary mechanism studied: Melanocortin MC4R Agonism. Primary indications investigated: Female sexual desire, Erectile dysfunction (off-label research).

Study Timeline

2022
2021
2020
Human RCTn = 627The Journal of Sexual Medicine

RECONNECT-1: A Randomized Controlled Trial of Bremelanotide for Female Sexual Desire Disorder

Clayton AH, Portman DJ, Kingsberg SA, et al.

Phase 3 double-blind RCT evaluating bremelanotide 1.75mg subcutaneous injection in premenopausal women with acquired HSDD. Primary endpoint was change in desire domain score.

Key finding: Bremelanotide significantly increased sexual desire scores (p<0.001) with 25% of women reporting much improved or very much improved vs 17% placebo.
PubMed 32371356
Human RCTn = 620The Journal of Sexual Medicine

RECONNECT-2: Phase 3 Trial of Bremelanotide in Premenopausal Women with Generalized Hypoactive Sexual Desire Disorder

Simon JA, Kingsberg SA, Shumel B, et al.

Second pivotal Phase 3 trial confirming bremelanotide efficacy in premenopausal women with generalized HSDD across 12 weeks of treatment.

Key finding: Bremelanotide improved desire domain scores (mean difference 3.9 vs 2.6 placebo, p<0.001) and reduced sexual distress significantly.
PubMed 32359572
2019
Human RCTn = 1247Obstetrics & Gynecology

Bremelanotide for Hypoactive Sexual Desire Disorder: A Randomized Clinical Trial (RECONNECT)

Kingsberg SA, Clayton AH, Portman D, et al.

Pivotal Phase 3 RECONNECT trials (combined n=1,247) meeting co-primary endpoints: significant increase in desire and reduction in distress vs placebo in premenopausal women with HSDD.

Key finding: Bremelanotide met both co-primary endpoints in the pivotal trials, leading to FDA approval as Vyleesi — the first on-demand treatment for female HSDD.
PubMed 31599840
ReviewTherapeutic Advances in Reproductive Health

Bremelanotide: new drug for hypoactive sexual desire disorder

Simon JA, Kingsberg SA, Portman D, et al.

Clinical review summarizing the full bremelanotide development program including mechanism, Phase 2 and 3 results, safety profile, and practical prescribing considerations.

Key finding: Comprehensive summary of bremelanotide clinical program: on-demand dosing, onset within 30-60 minutes, nausea as primary tolerability issue (40%), and favorable efficacy in HSDD.
PubMed 31844839
Human pilotn = 18Journal of Sexual Medicine

Bremelanotide Effects on Genital Arousal and Blood Flow: Functional MRI Study in Women with HSDD

Rosen RC, Segraves RT, Segraves KB, et al.

Functional neuroimaging study measuring brain activation and genital blood flow response to bremelanotide versus placebo during erotic stimuli.

Key finding: Bremelanotide increased prefrontal and hypothalamic activation (p<0.05) and genital blood flow by 34% compared to placebo during visual erotic stimuli.
PubMed 31109801
2018
2017
2016
Human RCTn = 327Womens Health

Bremelanotide for Female Sexual Dysfunctions in Premenopausal Women: A Randomized, Placebo-Controlled Dose-Finding Trial

Clayton AH, Althof SE, Kingsberg S, et al.

Phase 2 dose-finding RCT establishing 1.75mg as optimal dose. Bremelanotide significantly increased desire and reduced distress in premenopausal women with HSDD.

Key finding: Bremelanotide 1.75mg significantly improved sexual desire scores and reduced sexually related distress, establishing the dose for Phase 3.
PubMed 27216973
2015
2014
2013
2012
2006
ReviewInternational Journal of Impotence Research

Melanocortin-based therapeutics for erection and libido dysfunction

Hadley ME, Dorr RT.

Review tracing the discovery pathway from melanotan II tanning trials through the serendipitous observation of sexual effects to focused PT-141 development for both male and female sexual dysfunction.

Key finding: PT-141 demonstrated penile erection in men and increased sexual desire in women through central MC4R activation — a fundamentally novel mechanism distinct from all prior sexual health drugs.
PubMed 16107869
2004

How to read this timeline

The presence of a study does not mean an effect is established. Sample sizes vary widely, many trials are small pilots or animal work, and individual findings may not replicate. The overall evidence level for PT-141 is L5 (FDA Approved): fda-approved for at least one human indication. Treat each study as one data point, not a conclusion.

Frequently Asked Questions

How much human research exists on PT-141?

PeptideMark indexes 56 studies on PT-141: 18 human studies, 25 animal studies, 5 in-vitro, and 8 reviews. The current evidence level is L5 — fda approved.

When did PT-141 research begin?

The earliest indexed peer-reviewed study on PT-141 in the PeptideMark library was published in 2004 (Journal of Urology). Research activity has continued through 2022.

How long do PT-141 clinical trials typically run?

Duration varies by indication and phase. Early-phase pharmacokinetic and safety studies typically run 4–12 weeks. Phase 2 efficacy trials commonly span 12–26 weeks. Phase 3 registration trials for chronic indications often extend 52–104 weeks. Review individual trial records on ClinicalTrials.gov for specific durations.

Is PT-141 research still active?

Yes. Recent publications on PT-141 appear as recently as 2022, indicating ongoing investigation. See the research log on this page for the specific study.

Where can I see the raw research?

Every study referenced here links to its PubMed record via the study ID. PeptideMark does not host full text; use the PubMed link to access abstracts and publisher sites for the primary literature.

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