U.S. label record. The cited DailyMed label identifies Bremelanotide and contains the product's official indications and warnings. This profile links to the label without restating it as medical guidance.↗
Review source snapshots checked September 15, 2026 · Integrity checked September 15, 2026.
Three selected reports cover a phase 2 dose-finding trial, the two phase 3 RECONNECT trials, and a safety analysis that reuses development-program participants. Other populations and formulations are outside this synthesis.↗↗↗
What the reviewed sources report
RECONNECT reported improvements in desire and related distress in premenopausal women with hypoactive sexual desire disorder. Nausea, flushing and headache were more frequent with bremelanotide. Safety analyses overlap the efficacy-trial population.↗↗↗
What remains unresolved?
How do the magnitude of symptom changes, treatment discontinuation and patient preferences affect interpretation?↗↗↗
Which longer-term harms and populations remain inadequately characterized?↗↗↗
The cited U.S. label covers acquired, generalized hypoactive sexual desire disorder in premenopausal women, with specified exclusions. It does not cover men, postmenopausal women or enhancement of sexual performance. Label: 1 ↗
Which safety limits matter?
The label lists uncontrolled hypertension or known cardiovascular disease as contraindications. It describes transient blood-pressure increases, heart-rate reduction, focal hyperpigmentation and nausea. Label: 1, 4, 5 ↗
Label edition and source pins
U.S. product labeling hosted by the National Library of Medicine. This account concerns this product and label edition; other formulations and jurisdictions require their own records.
Label ZIP SHA-256: deb36c45aeecfb5e78f4b9ff837af0dfa1d12acf404c2d0424a6c279343cc780. Extracted XML SHA-256: 40f565dabb4834a5e8ae91adc6836df37b62102e1b94a57aa2bfc74969fa09be.
Reviews summarize selected studies; their scope and limitations are shown above.
Research coverage and study families
Search and screening record checked 2026-09-15. Counts describe records, not independent trials. Full-text appraisal is separate from an abstract review.
Primary reports of administration to people of the specified peptide; secondary reviews, animal/cell experiments and unrelated acronym matches are outside this scope. Selected summaries do not close the broader screening queue.
112 retrieved · 3 included · 1 excluded · 108 awaiting a decision · 2 full-text appraisals
Search terms, record decisions and remaining work
"bremelanotide"[Title/Abstract] OR "PT-141"[Title/Abstract]
Search covers PubMed title/abstract terms; regulator, registry, older aliases, non-indexed and non-English records require separate reconciliation.
Full-text appraisal and independent registry comparison remain incomplete.
Showing 25 of 112 record decisions, with included studies and unresolved records first. The versioned data inventory retains every record and study-family link.
PubMed 35147466 — include: Selected human report; abstract and record metadata reviewed. Study families: NCT02333071; NCT02338960; additional-program-studies-unresolved.
PubMed 31599840 — include: Selected human report; main full text and current registry comparison reviewed. Specific supplements, historical comparisons and unresolved issues remain identified in the structured reading. Study families: NCT02333071; NCT02338960.Structured full-text reading · PMC6819021
This is an editorial structured reading, not a validated risk-of-bias score.
RECONNECT comprised two separate randomized placebo-controlled trials with country-stratified blocks after a placebo run-in. Recognizable nausea could affect masking; the paper did not establish that participants remained unaware of assignment.
Missing data
Of 1,267 randomized participants, 1,247 entered safety analyses and 1,202 the modified intention-to-treat analysis. Only 856 completed, with more withdrawals on active treatment. Last-observation-carried-forward primary analyses do not remove attrition concerns.
Outcome selection
Desire and distress coprimary measures improved, while the prespecified satisfying-sexual-event count did not (integrated p=0.630). Later hierarchical secondary results are exploratory; a post hoc event percentage is not the failed count endpoint. Nausea occurred in 40.0% versus 1.3%; one hospitalization for vomiting/headache was considered treatment-related.
Applicability
The selected premenopausal population was predominantly White and US-based, with stable relationships and psychiatric-treatment exclusions. This does not establish safety or efficacy in excluded populations, including people at higher cardiovascular risk.
Funding and conflicts
Palatin sponsored and participated in design, execution, analysis and reporting. The authors reported access to individual and aggregate data; the public data-sharing statement did not offer participant data.
Registry comparison
NCT02333071 and NCT02338960 identify the two trials and agree on the coprimary measures. Their randomized flow totals (653 and 614) reconcile the paper; enrollment totals are not randomized counts. One record has inconsistent enrollment fields. Historical versions and linked supplements remain unresolved; the supplement link was unavailable during review.
PubMed 27181790 — include: Selected human report; main full text and current registry comparison reviewed. Specific supplements, historical comparisons and unresolved issues remain identified in the structured reading. Study families: NCT01382719.Structured full-text reading · PMC5384512
This is an editorial structured reading, not a validated risk-of-bias score.
The phase 2 study used diagnosis-stratified interactive randomization to four blinded groups with matching placebo after a placebo baseline period. The authors state placebo response was not used to exclude participants.
Missing data
Of 612 enrolled participants, 397 were randomized, 394 treated, 327 met modified efficacy-analysis criteria and 293 completed. Requiring a follow-up assessment excludes some randomized participants; these denominators must remain distinct.
Outcome selection
The prespecified pooled active comparison improved monthly satisfying events by 0.7 versus 0.2 (p=0.018). The first hierarchical secondary endpoint failed, so later questionnaire p-values were nominal/exploratory. Three active participants and one placebo participant reported serious events, considered unrelated; protocol blood-pressure withdrawals were reported separately from other adverse-event withdrawals.
Applicability
The trial enrolled selected premenopausal women with desire and/or arousal disorders, excluding uncontrolled hypertension and several psychiatric/gynecologic conditions. Its mixed diagnoses and short follow-up differ from the later phase 3 population.
Funding and conflicts
Palatin funded the study and editorial assistance. Three authors were company employees and stockholders, and other authors disclosed research or consulting relationships.
Registry comparison
NCT01382719 lists 612 enrolled, consistent with enrollment before randomization, and matches the satisfying-event primary endpoint and modified analysis population. The current registry secondary list is not a verification of the paper's claimed testing hierarchy; historical protocol and analysis-plan comparison remains open.
PubMed 18179455 — exclude: PubMed marks this report as a retracted publication; excluded from efficacy synthesis.
PubMed 42485063 — not screened: Retrieved for the broader search; eligibility has not yet been adjudicated.
PubMed 42340853 — not screened: Retrieved for the broader search; eligibility has not yet been adjudicated.
PubMed 41419078 — not screened: Retrieved for the broader search; eligibility has not yet been adjudicated.
PubMed 42254382 — not screened: Retrieved for the broader search; eligibility has not yet been adjudicated.
PubMed 42041173 — not screened: Retrieved for the broader search; eligibility has not yet been adjudicated.
PubMed 41960633 — not screened: Retrieved for the broader search; eligibility has not yet been adjudicated.
PubMed 42123471 — not screened: Retrieved for the broader search; eligibility has not yet been adjudicated.
PubMed 42021992 — not screened: Retrieved for the broader search; eligibility has not yet been adjudicated.
PubMed 42144994 — not screened: Retrieved for the broader search; eligibility has not yet been adjudicated.
PubMed 40543759 — not screened: Retrieved for the broader search; eligibility has not yet been adjudicated.
PubMed 41088800 — not screened: Retrieved for the broader search; eligibility has not yet been adjudicated.
PubMed 41002740 — not screened: Retrieved for the broader search; eligibility has not yet been adjudicated.
PubMed 40513668 — not screened: Retrieved for the broader search; eligibility has not yet been adjudicated.
PubMed 40518469 — not screened: Retrieved for the broader search; eligibility has not yet been adjudicated.
PubMed 40678415 — not screened: Retrieved for the broader search; eligibility has not yet been adjudicated.
PubMed 40069591 — not screened: Retrieved for the broader search; eligibility has not yet been adjudicated.
PubMed 39793696 — not screened: Retrieved for the broader search; eligibility has not yet been adjudicated.
PubMed 39846877 — not screened: Retrieved for the broader search; eligibility has not yet been adjudicated.
PubMed 39231849 — not screened: Retrieved for the broader search; eligibility has not yet been adjudicated.
PubMed 31369224 — not screened: Retrieved for the broader search; eligibility has not yet been adjudicated.
PubMed 38767282 — not screened: Retrieved for the broader search; eligibility has not yet been adjudicated.
ClinicalTrials.gov search
ClinicalTrials.gov API v2 identity-name search, complete retrieved records. Includes protocols, extensions, combinations and expanded access; these are not all efficacy trials or published outcomes.
10 retrieved · 10 included · 0 excluded · 0 awaiting a decision · 0 full-text appraisals
Registry identity screening is distinct from appraisal of posted results, protocol history and publication linkage.
Other registries and unregistered studies are outside this search.
Showing 10 of 10 record decisions, with included studies and unresolved records first. The versioned data inventory retains every record and study-family link.
ClinicalTrials.gov NCT03973047 — include: The intervention record names this molecule or its validated development code. Eligibility here is registry identity matching; outcomes and applicability remain separately unappraised. Study families: NCT03973047.
ClinicalTrials.gov NCT04179734 — include: The intervention record names this molecule or its validated development code. Eligibility here is registry identity matching; outcomes and applicability remain separately unappraised. Study families: NCT04179734.
ClinicalTrials.gov NCT06867835 — include: The intervention record names this molecule or its validated development code. Eligibility here is registry identity matching; outcomes and applicability remain separately unappraised. Study families: NCT06867835.
ClinicalTrials.gov NCT00425256 — include: The intervention record names this molecule or its validated development code. Eligibility here is registry identity matching; outcomes and applicability remain separately unappraised. Study families: NCT00425256.
ClinicalTrials.gov NCT01382719 — include: The intervention record names this molecule or its validated development code. Eligibility here is registry identity matching; outcomes and applicability remain separately unappraised. Study families: NCT01382719.
ClinicalTrials.gov NCT04943068 — include: The intervention record names this molecule or its validated development code. Eligibility here is registry identity matching; outcomes and applicability remain separately unappraised. Study families: NCT04943068.
ClinicalTrials.gov NCT02333071 — include: The intervention record names this molecule or its validated development code. Eligibility here is registry identity matching; outcomes and applicability remain separately unappraised. Study families: NCT02333071.
ClinicalTrials.gov NCT02338960 — include: The intervention record names this molecule or its validated development code. Eligibility here is registry identity matching; outcomes and applicability remain separately unappraised. Study families: NCT02338960.
ClinicalTrials.gov NCT06565611 — include: The intervention record names this molecule or its validated development code. Eligibility here is registry identity matching; outcomes and applicability remain separately unappraised. Study families: NCT06565611.
ClinicalTrials.gov NCT05709444 — include: The intervention record names this molecule or its validated development code. Eligibility here is registry identity matching; outcomes and applicability remain separately unappraised. Study families: NCT05709444.
FDA search
Exact active-ingredient terms in the openFDA Drugs@FDA endpoint, checked September 15. A zero result describes this indexed query only, not worldwide nonapproval or every FDA document.
1 retrieved · 1 included · 0 excluded · 0 awaiting a decision · 0 full-text appraisals
Search terms, record decisions and remaining work
products.active_ingredients.name:"BREMELANOTIDE" OR products.active_ingredients.name:"BREMELANOTIDE ACETATE"
This query does not cover all FDA safety communications, labels, compounding proceedings or other regulatory systems.
Showing 1 of 1 record decisions, with included studies and unresolved records first. The versioned data inventory retains every record and study-family link.
FDA NDA210557 — include: The application record contains the queried ingredient; indications, labels and approval documents require their own review.
EMA search
Local identity matching in the pinned EMA medicines metadata feed. This feed is not every national European authorization or every agency document; orphan designation is not marketing authorization.
0 retrieved · 0 included · 0 excluded · 0 awaiting a decision · 0 full-text appraisals
Search terms, record decisions and remaining work
Case-insensitive word-boundary matching of reviewed identity terms: ["bremelanotide", "Vyleesi", "PT-141"]
Complete source-document appraisal and national European sources remain open.
Zero identity matches apply only to these feed fields and terms.
Showing 0 of 0 record decisions, with included studies and unresolved records first. The versioned data inventory retains every record and study-family link.
EMA search
Local identity matching in the pinned EMA documents metadata feed. This feed is not every national European authorization or every agency document; orphan designation is not marketing authorization.
0 retrieved · 0 included · 0 excluded · 0 awaiting a decision · 0 full-text appraisals
Search terms, record decisions and remaining work
Case-insensitive word-boundary matching of reviewed identity terms: ["bremelanotide", "Vyleesi", "PT-141"]
Complete source-document appraisal and national European sources remain open.
Zero identity matches apply only to these feed fields and terms.
Showing 0 of 0 record decisions, with included studies and unresolved records first. The versioned data inventory retains every record and study-family link.
EMA search
Local identity matching in the pinned EMA orphans metadata feed. This feed is not every national European authorization or every agency document; orphan designation is not marketing authorization.
0 retrieved · 0 included · 0 excluded · 0 awaiting a decision · 0 full-text appraisals
Search terms, record decisions and remaining work
Case-insensitive word-boundary matching of reviewed identity terms: ["bremelanotide", "Vyleesi", "PT-141"]
Complete source-document appraisal and national European sources remain open.
Zero identity matches apply only to these feed fields and terms.
Showing 0 of 0 record decisions, with included studies and unresolved records first. The versioned data inventory retains every record and study-family link.
Read the full Human Evidence Review
Supervised synthesis
What do selected human studies report about Bremelanotide?
Three selected reports cover a phase 2 dose-finding trial, the two phase 3 RECONNECT trials, and a safety analysis that reuses development-program participants. Other populations and formulations are outside this synthesis.123
Bottom line from this bounded source set
RECONNECT reported improvements in desire and related distress in premenopausal women with hypoactive sexual desire disorder. Nausea, flushing and headache were more frequent with bremelanotide. Safety analyses overlap the efficacy-trial population.123
Reviewed study record
RECONNECT: two phase 3 trials
Design
Two blinded randomized placebo-controlled trials assessed 24-week changes in desire and distress scores.1
Population
Of 1,267 premenopausal women randomized, 1,247 were in the safety population and 1,202 in the efficacy population; most were White and enrolled in the United States.1
Outcomes reported
Both studies reported improvements in the two primary symptom scores compared with placebo. Nausea, flushing and headache occurred more often with bremelanotide.1
Limitations
The endpoints were questionnaire scores in a selected population. These results do not establish benefit in other sexual disorders or demographic groups.1
Reviewed study record
Development-program safety analysis
Design
An integrated report reviewed safety across clinical development, including the RECONNECT randomized and open-label periods.2
Population
The program included approximately 3,500 participants across 43 studies; the integrated blinded phase 3 analysis included 1,247.2
Outcomes reported
Nausea was the most common reason for stopping bremelanotide. The report also described transient blood-pressure increases and focal hyperpigmentation.2
Limitations
The integrated data overlap other trial reports and cannot be counted as an independent replication. Open-label continuation introduces selection and attrition.2
Reviewed study record
Phase 2 dose-finding study
Design
A randomized placebo-controlled study assessed outcomes over 12 weeks.3
Population
The efficacy analysis included 327 premenopausal women with female sexual dysfunction.3
Outcomes reported
The pooled active groups improved reported satisfying sexual events and questionnaire measures compared with placebo; nausea, flushing and headache were reported.3
Limitations
Pooled exposure groups, a different primary endpoint and short follow-up limit comparison with phase 3 results. This report is not a head-to-head comparison with another medicine.3
No registered Crossref update in the reviewed snapshotChecked September 15, 2026 for DOI 10.1097/aog.0000000000003500. This bounded result is not proof that the publication has never been corrected or retracted. Open the pinned Crossref work endpoint ↗
No registered Crossref update in the reviewed snapshotChecked September 15, 2026 for DOI 10.1089/jwh.2021.0191. This bounded result is not proof that the publication has never been corrected or retracted. Open the pinned Crossref work endpoint ↗
No registered Crossref update in the reviewed snapshotChecked September 15, 2026 for DOI 10.2217/whe-2016-0018. This bounded result is not proof that the publication has never been corrected or retracted. Open the pinned Crossref work endpoint ↗
Explore status sources, recent additions, and coverage gaps
Living status brief
What is the current status of Bremelanotide?
U.S. label record. The cited DailyMed label identifies Bremelanotide and contains the product's official indications and warnings. This profile links to the label without restating it as medical guidance.↗
The cited status sources were checked through July 22, 2026. This answer changes only through the profile’s visible version and correction history.
PeptideScanner currently has no selected safety records connected to this profile. That is a collection gap, not evidence that no such records exist.
PeptideScanner does not infer an answer where the cited records do not provide one. Open the source-linked records below to inspect their scope and limits.
This map describes PeptideScanner’s selected, source-linked collection. It is not an evidence grade and does not establish research quality, safety, effectiveness, or medical relevance.
Bibliography fields unavailable here for 16 selected records; the records remain visible as metadata observations.
Regulatory and publication surfaces
What is structurally connected?
Drugs@FDA applications
1
FDA Federal Register documents
2
DailyMed SPL versions
1
Canonical profile
Published
Profile structured data
Published
Linked dated records
31
Application counts reflect exact reviewed ingredient connections; Federal Register counts reflect exact reviewed peptide-name matches; DailyMed counts reflect listed SPL versions with retained ZIP receipts. “Published” describes this page’s indexing surface, not the state of scientific evidence.
PeptideScanner retained ClinicalTrials.gov record NCT03973047 at 2026-07-30T19:40:58.916Z. Its registry update date was 2022-04-04, and PeptideScanner's reviewed identity mapping was bremelanotide.
PeptideScanner retained ClinicalTrials.gov record NCT04179734 at 2026-07-30T18:41:37.916Z. Its registry update date was 2024-08-09, and PeptideScanner's reviewed identity mapping was bremelanotide.
DailyMed lists Structured Product Labeling version 1 for the reviewed Bremelanotide label family with a published date of 2025-11-18. PeptideScanner retained the exact versioned ZIP byte count and SHA-256 receipt without republishing its contents.
Counts and links describe PeptideScanner’s selected records. They are not rankings and do not establish research quality, safety, effectiveness, or medical relevance.
These links are based only on overlapping years and evidence lanes in PeptideScanner’s selected records. They do not imply that the peptides are medically or scientifically similar.
These dates come from selected source records and PubMed metadata. They are not a complete or continuous timeline of research, safety, approval, or effectiveness.
Evidence summary
What the cited records say
The cited DailyMed label identifies Bremelanotide and contains the product's official indications and warnings. This profile links to the label without restating it as medical guidance.↗
This is a source summary, not a medical recommendation. Status may differ by jurisdiction and product.
PeptideScanner retained PubMed bibliographic metadata for PMID 42485063 at 2026-08-10T18:13:56.710Z. PubMed recorded a metadata revision date of 2026-07-22 and an Entrez history date of 2026-07-22. PeptideScanner associated this retained record with the identity slug bremelanotide. These dates describe PubMed metadata history, not the article's original publication date.↗
PeptideScanner retained PubMed bibliographic metadata for PMID 39793696 at 2026-07-30T16:20:39.143Z. PubMed recorded a metadata revision date of 2026-05-24 and an Entrez history date of 2025-01-10. PeptideScanner associated this retained record with the identity slug bremelanotide. These dates describe PubMed metadata history, not the article's original publication date.↗
PeptideScanner retained PubMed bibliographic metadata for PMID 41960633 at 2026-07-30T16:22:18.490Z. PubMed recorded a metadata revision date of 2026-04-24 and an Entrez history date of 2026-04-10. PeptideScanner associated this retained record with the identity slug bremelanotide. These dates describe PubMed metadata history, not the article's original publication date.↗
DailyMed lists Structured Product Labeling version 1 for the reviewed Bremelanotide label family with a published date of 2025-11-18. PeptideScanner retained the exact versioned ZIP byte count and SHA-256 receipt without republishing its contents.↗
PeptideScanner retained ClinicalTrials.gov record NCT04943068 at 2026-07-30T18:38:25.522Z. Its registry update date was 2024-11-13, and PeptideScanner's reviewed identity mapping was bremelanotide.↗
PeptideScanner retained ClinicalTrials.gov record NCT05709444 at 2026-07-30T18:39:33.780Z. Its registry update date was 2024-10-17, and PeptideScanner's reviewed identity mapping was bremelanotide.↗
PeptideScanner retained ClinicalTrials.gov record NCT04179734 at 2026-07-30T18:41:37.916Z. Its registry update date was 2024-08-09, and PeptideScanner's reviewed identity mapping was bremelanotide.↗
PubMed lists PMID 32353679 in Journal of pharmaceutical and biomedical analysis as Journal Article, with publication-date metadata of 2020-03-27 (day precision). PeptideScanner associated the retained record with the identity slug bremelanotide. These fields reproduce attributed bibliographic metadata and do not summarize or endorse the article's findings.↗
PubMed lists PMID 36242769 in Expert opinion on pharmacotherapy as Journal Article, Review, with publication-date metadata of 2022-10-18 (day precision). PeptideScanner associated the retained record with the identity slug bremelanotide. These fields reproduce attributed bibliographic metadata and do not summarize or endorse the article's findings.↗
PubMed lists PMID 33455598 in CNS spectrums as Journal Article, Review, Research Support, Non-U.S. Gov't, with publication-date metadata of 2021-01-18 (day precision). PeptideScanner associated the retained record with the identity slug bremelanotide. These fields reproduce attributed bibliographic metadata and do not summarize or endorse the article's findings.↗
PeptideScanner retained ClinicalTrials.gov record NCT03973047 at 2026-07-30T19:40:58.916Z. Its registry update date was 2022-04-04, and PeptideScanner's reviewed identity mapping was bremelanotide.↗
PubMed lists PMID 35230162 in Journal of women's health (2002) as Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't, with publication-date metadata of 2022-02-25 (day precision). PeptideScanner associated the retained record with the identity slug bremelanotide. These fields reproduce attributed bibliographic metadata and do not summarize or endorse the article's findings.↗