{"id":"on101-cream","safety":{"commonSideEffects":[{"rate":null,"effect":"Local irritation or erythema at application site"},{"rate":null,"effect":"Infection risk at wound site"},{"rate":null,"effect":"Allergic reaction to formulation components"}]},"_chembl":{"chemblId":"CHEMBL2108947","moleculeType":"Unknown"},"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"ON101 is a proprietary topical cream containing recombinant human basic fibroblast growth factor (bFGF) that stimulates angiogenesis, fibroblast proliferation, and extracellular matrix deposition. It is designed to accelerate the healing process in chronic wounds by promoting granulation tissue formation and re-epithelialization through growth factor-mediated cellular signaling.","oneSentence":"ON101 Cream is a topical formulation that promotes wound healing and tissue repair through growth factor signaling and anti-inflammatory mechanisms.","_ai_confidence":"medium"},"_scrapedAt":"2026-03-27T23:58:17.584Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Chronic diabetic foot ulcers"},{"name":"Pressure ulcers / decubitus ulcers"}]},"trialDetails":[{"nctId":"NCT05135130","phase":"","title":"Retrospective Record-review Study in Patients Who Had Diabetic Foot Ulcer","status":"COMPLETED","sponsor":"Oneness Biotech Co., Ltd.","startDate":"2021-10-04","conditions":"Diabetic Foot Ulcer","enrollment":160},{"nctId":"NCT04962139","phase":"PHASE3","title":"Evaluate the Safety and Efficacy of ON101 Cream for the Treatment of Chronic Diabetic Foot Ulcers","status":"TERMINATED","sponsor":"Oneness Biotech Co., Ltd.","startDate":"2021-07-27","conditions":"Chronic Diabetic Foot Ulcers","enrollment":12},{"nctId":"NCT05322525","phase":"PHASE4","title":"A Research Study to Evaluate the Safety and Potential Efficacy of ON101 Cream for the Treatment of Venous Leg Ulcers.","status":"TERMINATED","sponsor":"Oneness Biotech Co., Ltd.","startDate":"2021-06-23","conditions":"Venous Leg Ulcers (VLU)","enrollment":9},{"nctId":"NCT05438251","phase":"PHASE4","title":"Exploring the Effect of Fespixon Cream for the Treatment of Diabetic Foot Ulcers (TEXAS 3A, 3B)","status":"TERMINATED","sponsor":"Oneness Biotech Co., Ltd.","startDate":"2022-08-04","conditions":"Diabetic Foot Ulcer (DFU)","enrollment":3},{"nctId":"NCT05317442","phase":"PHASE4","title":"Open-label Study to Evaluate the Efficacy and Safety of Fespixon Cream for the Treatment of Pressure Injury in Sacrum and Greater Trochanter Wound","status":"TERMINATED","sponsor":"Taipei Medical University WanFang Hospital","startDate":"2022-04-06","conditions":"Pressure Injury Stage 2","enrollment":10},{"nctId":"NCT05338463","phase":"PHASE4","title":"Fespixon Cream for the Treatment of Chronic Diabetic Foot Ulcers (TEXAS 1A, 2A) in Dialysis Patients","status":"COMPLETED","sponsor":"Cathay General Hospital","startDate":"2021-12-01","conditions":"Chronic Diabetic Foot Ulcer","enrollment":5},{"nctId":"NCT04945161","phase":"NA","title":"A Randomized,Double-blind,Placebo-controlled Clinical Study to Explore the Mechanism of Action of ON101 Cream in Patients With DFUs.","status":"COMPLETED","sponsor":"Oneness Biotech Co., Ltd.","startDate":"2021-02-23","conditions":"Diabetic Foot Ulcers","enrollment":13},{"nctId":"NCT05271708","phase":"PHASE4","title":"Explore the Short- and Mid-term Effects of Fespixon in Scar Cosmesis Following Cervical or Abdominal Surgery","status":"COMPLETED","sponsor":"National Defense Medical Center, Taiwan","startDate":"2022-01-05","conditions":"Scar","enrollment":46},{"nctId":"NCT01898923","phase":"PHASE3","title":"Evaluate the Efficacy and Safety of ON101 Cream for the Treatment of Chronic Diabetic Foot Ulcers","status":"COMPLETED","sponsor":"Oneness Biotech Co., Ltd.","startDate":"2012-11-23","conditions":"Diabetic Foot","enrollment":236}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":0,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":["WH-1","Fespixon"],"phase":"marketed","status":"active","brandName":"ON101 Cream","genericName":"ON101 Cream","companyName":"Oneness Biotech Co., Ltd.","companyId":"oneness-biotech-co-ltd","modality":"Small molecule","firstApprovalDate":"","aiSummary":"ON101 Cream is a topical formulation that promotes wound healing and tissue repair through enhanced growth factor signaling and cellular regeneration. Used for Chronic wounds and diabetic foot ulcers.","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":3,"withResults":1},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}