{
 "checked": "2026-10-24 (America/New_York)",
 "page": "https://jabbitapp.com/research/pt-141-bremelanotide-vyleesi-evidence-teardown.html",
 "label": {
  "source": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=f1d0c1b5-2f39-4bad-a6a4-0066e3ad5dcf",
  "effective_time": "20251113",
  "labeler": [
   "Cosette Pharmaceuticals, Inc."
  ],
  "nda": [
   "NDA210557"
  ],
  "indication": "premenopausal women with acquired, generalized HSDD; not indicated for postmenopausal women or men; not indicated to enhance sexual performance",
  "table1_pct_vyleesi_vs_placebo": {
   "nausea": [
    40.0,
    1.3
   ],
   "flushing": [
    20.3,
    0.3
   ],
   "injection site reactions": [
    13.2,
    8.4
   ],
   "headache": [
    11.3,
    1.9
   ],
   "vomiting": [
    4.8,
    0.2
   ]
  },
  "n_safety": [
   627,
   620
  ],
  "discontinued_for_adverse_reactions_pct": [
   18,
   2
  ],
  "nausea_antiemetic_pct": 13,
  "nausea_discontinued_pct": 8,
  "hyperpigmentation": {
   "phase3_pct": 1,
   "daily_8_days_pct": 38,
   "additional_after_8_more_days_pct": 14
  },
  "bp": {
   "max_sbp_mmHg": 6,
   "max_dbp_mmHg": 3,
   "hr_drop_bpm": 5,
   "resolves_hours": 12
  },
  "fsfi_desire_mean_change": {
   "study1": [
    0.5,
    0.2
   ],
   "study2": [
    0.6,
    0.2
   ]
  },
  "fsds_q13_mean_change": {
   "study1": [
    -0.7,
    -0.4
   ],
   "study2": [
    -0.7,
    -0.4
   ]
  },
  "discontinued_double_blind_pct": {
   "study1": [
    40,
    13
   ],
   "study2": [
    39,
    25
   ]
  }
 },
 "fda_2019": {
  "source": "https://web.archive.org/web/20191225234451/https://www.fda.gov/news-events/press-announcements/fda-approves-new-treatment-hypoactive-sexual-desire-disorder-premenopausal-women",
  "desire_responders_pct": [
   25,
   17
  ],
  "distress_responders_pct": [
   35,
   31
  ],
  "satisfying_sexual_events": "no difference",
  "hyperpigmentation_not_resolved": "about half"
 },
 "faers": {
  "query": "openFDA drug/event, patient.drug.openfda.generic_name:\"bremelanotide\" (reports linked to the approved product's NDC/label harmonization); openFDA last_updated 2026-07-30, reports received through 2026-06-30",
  "endpoint": "https://api.fda.gov/drug/event.json?search=patient.drug.openfda.generic_name:%22bremelanotide%22&count=patient.patientsex",
  "total_reports": 1004,
  "female": 883,
  "male": 50,
  "sex_unknown_or_missing": 71,
  "by_receipt_year": {
   "2019": 40,
   "2020": 50,
   "2021": 18,
   "2022": 45,
   "2023": 150,
   "2024": 155,
   "2025": 341,
   "2026": 205
  },
  "male_top_reactions": [
   [
    "OFF LABEL USE",
    37
   ],
   [
    "NAUSEA",
    20
   ],
   [
    "DRUG INEFFECTIVE",
    8
   ],
   [
    "PRODUCT USE ISSUE",
    8
   ],
   [
    "ERECTION INCREASED",
    6
   ],
   [
    "HEADACHE",
    6
   ],
   [
    "ABDOMINAL PAIN UPPER",
    4
   ],
   [
    "DIARRHOEA",
    3
   ],
   [
    "PAINFUL ERECTION",
    3
   ],
   [
    "PRODUCT PRESCRIBING ISSUE",
    3
   ]
  ],
  "caveat": "FAERS reports are unverified, can be duplicated, and do not prove a drug caused an event; counts rise with use and reporting programs."
 },
 "registry_census": {
  "query": "ClinicalTrials.gov API v2, query.intr = bremelanotide OR PT-141, pulled 2026-10-24",
  "total": 10,
  "female_only": 8,
  "open_to_men": [
   "NCT05709444",
   "NCT06565611"
  ],
  "erectile_dysfunction_records": [],
  "with_posted_results": 4,
  "active_or_recruiting": [
   "NCT06565611"
  ],
  "studies": [
   {
    "nct": "NCT00425256",
    "title": "Evaluate the Safety and Efficacy of Bremelanotide in Women With Female Sexual Arousal Disorder (FSAD)",
    "conditions": [
     "Sexual Arousal Disorder"
    ],
    "phase": "PHASE2",
    "status": "COMPLETED",
    "sex": "FEMALE",
    "enrollment": null,
    "start": "2006-02",
    "lead_sponsor": "Palatin Technologies, Inc",
    "has_results": false
   },
   {
    "nct": "NCT01382719",
    "title": "Bremelanotide in Premenopausal Women With Female Sexual Arousal Disorder and/or Hypoactive Sexual Desire Disorder",
    "conditions": [
     "Female Sexual Arousal Disorder",
     "Hypoactive Sexual Desire Disorder"
    ],
    "phase": "PHASE2",
    "status": "COMPLETED",
    "sex": "FEMALE",
    "enrollment": 612,
    "start": "2011-06",
    "lead_sponsor": "Palatin Technologies, Inc",
    "has_results": true
   },
   {
    "nct": "NCT02333071",
    "title": "1. Study to Evaluate the Efficacy/Safety of Bremelanotide in Premenopausal Women With Hypoactive Sexual Desire Disorder",
    "conditions": [
     "Hypoactive Sexual Desire Disorder"
    ],
    "phase": "PHASE3",
    "status": "COMPLETED",
    "sex": "FEMALE",
    "enrollment": 723,
    "start": "2014-12",
    "lead_sponsor": "Palatin Technologies, Inc",
    "has_results": true
   },
   {
    "nct": "NCT02338960",
    "title": "2. Study to Evaluate the Efficacy/Safety of Bremelanotide in Premenopausal Women With Hypoactive Sexual Desire Disorder",
    "conditions": [
     "Hypoactive Sexual Desire Disorder"
    ],
    "phase": "PHASE3",
    "status": "COMPLETED",
    "sex": "FEMALE",
    "enrollment": 714,
    "start": "2015-01",
    "lead_sponsor": "Palatin Technologies, Inc",
    "has_results": true
   },
   {
    "nct": "NCT03973047",
    "title": "Study to Evaluate Rate of Nausea in Healthy Premenopausal Female Subjects Treated With Single Dose of Bremelanotide Alone or With Zofran",
    "conditions": [
     "Nausea"
    ],
    "phase": "PHASE1",
    "status": "COMPLETED",
    "sex": "FEMALE",
    "enrollment": 228,
    "start": "2019-06-17",
    "lead_sponsor": "AMAG Pharmaceuticals, Inc.",
    "has_results": false
   },
   {
    "nct": "NCT04179734",
    "title": "Role of the Melanocortin-4 Receptor in Hypoactive Sexual Desire Disorder",
    "conditions": [
     "Hypoactive Sexual Desire Disorder"
    ],
    "phase": "PHASE4",
    "status": "COMPLETED",
    "sex": "FEMALE",
    "enrollment": 40,
    "start": "2019-10-07",
    "lead_sponsor": "Imperial College Healthcare NHS Trust",
    "has_results": true
   },
   {
    "nct": "NCT04943068",
    "title": "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)",
    "conditions": [
     "Hypoactive Sexual Desire Disorder"
    ],
    "phase": "PHASE3",
    "status": "COMPLETED",
    "sex": "FEMALE",
    "enrollment": 193,
    "start": "2021-05-10",
    "lead_sponsor": "Kwang Dong Pharmaceutical co., ltd.",
    "has_results": false
   },
   {
    "nct": "NCT05709444",
    "title": "A Phase IIb, Multicenter, Open-Label, Prospective Study of Bremelanotide in Diabetic Kidney Disease",
    "conditions": [
     "Kidney Disease"
    ],
    "phase": "PHASE2",
    "status": "COMPLETED",
    "sex": "ALL",
    "enrollment": 16,
    "start": "2022-12-26",
    "lead_sponsor": "Palatin Technologies, Inc",
    "has_results": false
   },
   {
    "nct": "NCT06565611",
    "title": "A Phase 2 Study Evaluating the Co-Administration of Bremelanotide With Tirzepatide for the Treatment of Obesity",
    "conditions": [
     "Obesity"
    ],
    "phase": "PHASE2",
    "status": "ACTIVE_NOT_RECRUITING",
    "sex": "ALL",
    "enrollment": 108,
    "start": "2024-08-05",
    "lead_sponsor": "Palatin Technologies, Inc",
    "has_results": false
   },
   {
    "nct": "NCT06867835",
    "title": "Single Dose of Vyleesi in Lactating Female Subjects to Measure the Concentration of Bremelanotide in Breast Milk",
    "conditions": [
     "Lactating Mother"
    ],
    "phase": "PHASE4",
    "status": "COMPLETED",
    "sex": "FEMALE",
    "enrollment": 10,
    "start": "2025-07-11",
    "lead_sponsor": "Cosette Pharmaceuticals, Inc.",
    "has_results": false
   }
  ]
 },
 "analysis": {
  "desire_responder_gap_points": 8,
  "distress_responder_gap_points": 4,
  "number_needed_to_treat_desire_approx": 12.5,
  "kingsberg_2019_placebo_adjusted": {
   "desire": 0.35,
   "distress": -0.33,
   "desire_scale": "1.2 to 6.0",
   "distress_scale": "0 to 4"
  },
  "male_share_of_faers_pct": 5.0,
  "male_reports_coded_off_label": 37,
  "note": "Our arithmetic from FDA's responder rates and the label. Number needed to treat is a rough illustration from rounded figures."
 },
 "warning_letters_2026_08_24_naming_pt141": [
  "733652",
  "735063",
  "734884",
  "735067",
  "735127"
 ],
 "palatin_sec": {
  "8k_2025_03_31_ex99_2": "https://www.sec.gov/Archives/edgar/data/911216/000165495425003600/ptn_ex992.htm",
  "10k_fy2026": "https://www.sec.gov/Archives/edgar/data/911216/000149315226044572/form10-k.htm",
  "10k_fy2008": "https://www.sec.gov/Archives/edgar/data/911216/000108802008000050/form10k_063008.htm",
  "8k_2023_12_20_ex99_1": "https://www.sec.gov/Archives/edgar/data/911216/000165495423015795/ptn_ex991.htm"
 },
 "publication_notices": {
  "PMID 18206919 (J Urol 2008, men)": "Expression of concern, J Urol 2023 (PMID 36626345)",
  "PMID 18179455 (J Sex Med 2008, women)": "Retracted"
 }
}