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Scientific Evidence Record · Sexual Function

PT-141 (BREMELANOTIDE)

A scientific record of the published literature, kept separate from THAI BIO LABS lot-level analytical documentation and commercial availability.

Selected sources checked: · Content version2.1 · AI-assisted screening; specialist review pending

Selected evidenceIndication-specific clinical findings
Supply contextResearch supply only
Review statusSpecialist review pending
Reading framework

Scope of this summary

Desire and distress in a defined clinical population

Review contents

THAI BIO LABS scientific assessment

Evidence in context.

Key takeaways
  • PT-141/bremelanotide has randomised phase 3 evidence in a defined population of premenopausal women with hypoactive sexual desire disorder. That scope does not establish a general enhancement effect. [1]
  • Do not extend findings to men, other diagnoses or different preparations without matching evidence.

PT-141/bremelanotide has randomised phase 3 evidence in a defined population of premenopausal women with hypoactive sexual desire disorder. That scope does not establish a general enhancement effect. [1]

Research overview

What the published record is evaluating.

The clinical papers evaluate a specified bremelanotide pharmaceutical preparation. A research vial requires separate identity, content and batch documentation. [1]

Selected studies

Findings and their limits.

The RECONNECT publication reports two randomised, double-blind, placebo-controlled phase 3 trials. The principal questions concern sexual desire and associated distress in the enrolled population, not every aspect of sexual function. [1] The trials improved the desire/distress endpoints, but the secondary count of satisfying sexual events did not differ significantly. [1]

A separate 52-week open-label extension provides additional safety observations. Its selected participants and lack of a concurrent blinded control limit comparison with the randomised phase. [2] Of 684 participants who entered the extension, 272 completed it. [2]

Primary research areas
  • Desire and distress in a defined clinical population

Evidence quality

Strengths and limitations, shown together.

Strengths
  • The linked records make the study setting and measured endpoints checkable. They should be read with their design limitations.
Current limitations
  • Do not extend findings to men, other diagnoses or different preparations without matching evidence.
  • This is a selected source summary, not a systematic review of all studies or a clinical recommendation.

Safety & tolerability evidence

Published safety context.

In the randomised trials, nausea was reported by 40.0% with bremelanotide versus 1.3% with placebo. [1]

The selected studies do not establish the safety of a TBL research vial. Study-specific adverse-event reporting, formulation and follow-up must be assessed separately from analytical batch documentation.

Scientific outlook

Where the evidence may develop next.

Future updates should add identifiable primary studies, explain whether they change the conclusion, and retain relevant negative findings.

Selected references

Selected references from the published record.

These linked sources support the numbered statements above. This is a selected summary, not an exhaustive or independently signed-off systematic review. Sponsor announcements are labelled separately from published studies.

  1. Kingsberg et al. RECONNECT trials, 2019. PMID 31599840. · Primary study
  2. Bremelanotide open-label extension, 2019. PMID 31599847. · Primary study

INTERPRETATION FRAMEWORK

Different records. Different questions.

Three connected layers help interpret the evidence. They answer different questions and cannot substitute for one another.

Narrative Review

What the published scientific record reports, including its scope, findings and limitations.

Evidence Index

A structured reading framework. For metabolic peptides, it also preserves the original dated editorial scores and component breakdowns.

Batch Record

Analytical identity and other lot-specific documentation for a THAI BIO LABS material, when published.

Use the Evidence Index to examine the research interpretation and Batch Records to review documentation for a specific lot.

Research-use boundary

Clinical literature and THAI BIO LABS research materials are not the same record.

Published studies may concern approved medicines, investigational pharmaceutical material or other controlled research preparations. THAI BIO LABS materials are supplied for laboratory research use only and are not represented as medicines or substitutes for regulated pharmaceutical products.

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