{"id":"cb-03-01","safety":{"commonSideEffects":[{"rate":null,"effect":"Sexual dysfunction"},{"rate":null,"effect":"Decreased libido"},{"rate":null,"effect":"Gynecomastia"}]},"_chembl":{"chemblId":"CHEMBL3590187","moleculeType":"Small molecule","molecularWeight":"402.53"},"_dailymed":null,"mechanism":{"_ai_source":"anthropic-haiku","explanation":"CB-03-01 works by blocking the enzyme 5-alpha reductase, which converts testosterone to dihydrotestosterone (DHT), the primary driver of male pattern hair loss. By reducing local DHT levels in hair follicles, it aims to prevent hair loss and potentially promote regrowth. This mechanism differs from systemic hormonal approaches by targeting the biochemical pathway directly involved in androgenetic alopecia.","oneSentence":"CB-03-01 is a selective androgen receptor modulator (SARM) that inhibits 5-alpha reductase to reduce DHT-driven androgenetic alopecia.","_ai_confidence":"medium"},"_scrapedAt":"2026-03-28T01:49:42.271Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Androgenetic alopecia (male pattern hair loss)"}]},"trialDetails":[{"nctId":"NCT05910450","phase":"PHASE3","title":"A Study to Evaluate the Efficacy and Safety of Clascoterone Solution in Treatment of Male Pattern Hair Loss","status":"ACTIVE_NOT_RECRUITING","sponsor":"Cassiopea SpA","startDate":"2023-06-21","conditions":"Alopecia, Androgenetic","enrollment":703},{"nctId":"NCT05914805","phase":"PHASE3","title":"A Study to Evaluate the Efficacy and Safety of Clascoterone Solution in Treatment of Male Pattern Hair Loss (SCALP2)","status":"COMPLETED","sponsor":"Cassiopea SpA","startDate":"2023-08-17","conditions":"Alopecia, Androgenetic","enrollment":762},{"nctId":"NCT01831960","phase":"PHASE2","title":"An Evaluation of the Adrenal Suppression Potential and Pharmacokinetic Properties of CB-03-01 Cream in Subjects With Acne Vulgaris","status":"COMPLETED","sponsor":"Intrepid Therapeutics, Inc.","startDate":"2013-04","conditions":"Acne Vulgaris","enrollment":42},{"nctId":"NCT02608476","phase":"PHASE3","title":"A Study to Evaluate the Safety and Efficacy of CB-03-01 Cream, 1% in Subjects With Facial Acne Vulgaris (26)","status":"COMPLETED","sponsor":"Cassiopea SpA","startDate":"2015-11-16","conditions":"Acne Vulgaris","enrollment":732},{"nctId":"NCT02720627","phase":"PHASE2","title":"An Evaluation of the Adrenal Suppression Potential and PK of CB-03-01 Cream in Pediatric Patients With Acne Vulgaris","status":"COMPLETED","sponsor":"Cassiopea SpA","startDate":"2016-10-28","conditions":"Acne Vulgaris","enrollment":27},{"nctId":"NCT02608450","phase":"PHASE3","title":"A Study to Evaluate the Safety and Efficacy of CB-03-01 Cream, 1% in Subjects With Facial Acne Vulgaris (25)","status":"COMPLETED","sponsor":"Cassiopea SpA","startDate":"2016-01-21","conditions":"Acne Vulgaris","enrollment":708},{"nctId":"NCT02682264","phase":"PHASE3","title":"An Open-Label, Long-Term Extension Study to Evaluate the Safety of CB-03-01 Cream, 1% in Participants With Acne Vulgaris","status":"COMPLETED","sponsor":"Cassiopea SpA","startDate":"2016-03-09","conditions":"Acne Vulgaris","enrollment":609},{"nctId":"NCT01631474","phase":"PHASE2","title":"A Phase 2 Dose Escalating Study to Evaluate the Safety and Efficacy of CB-03-01 Cream in Subjects With Facial Acne Vulgaris","status":"COMPLETED","sponsor":"Intrepid Therapeutics, Inc.","startDate":"2012-06","conditions":"Acne Vulgaris","enrollment":363},{"nctId":"NCT02279823","phase":"PHASE2","title":"A Phase 2 Study to Evaluate the Safety and Efficacy of CB-03-01 Solution, a Comparator Solution and Vehicle Solution in Males With Androgenetic Alopecia","status":"COMPLETED","sponsor":"Intrepid Therapeutics, Inc.","startDate":"2014-10","conditions":"Androgenetic Alopecia","enrollment":95}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":11,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":["clascoterone","cortexolone 17α-propionate"],"phase":"phase_2","status":"active","brandName":"CB-03-01","genericName":"CB-03-01","companyName":"Intrepid Therapeutics, Inc.","companyId":"intrepid-therapeutics-inc","modality":"Small molecule","firstApprovalDate":"","aiSummary":"CB-03-01 is a selective androgen receptor modulator (SARM) that inhibits 5-alpha reductase to reduce DHT-driven androgenetic alopecia. Used for Androgenetic alopecia (male pattern hair loss).","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}