{"id":"becaplermin","rwe":[{"pmid":"41306208","year":"2025","title":"Recombinant Platelet-Derived Growth Factor-BB (rhPDGF-BB) Augmented Collagen Grafting for Oral Mucosal Defect Reconstruction.","finding":"","journal":"Journal of maxillofacial and oral surgery","studyType":"Clinical Study"},{"pmid":"41220237","year":"2025","title":"Safety of up to 140 Daily Applications of Recombinant Human Platelet-Derived Growth Factor (rhPDGF-BB) Onto Skin Wounds: Unboxing the Evidence.","finding":"","journal":"Wound repair and regeneration : official publication of the Wound Healing Society [and] the European Tissue Repair Society","studyType":"Clinical Study"},{"pmid":"39421656","year":"2024","title":"Targeting Matrix Metalloproteinase-9 for Therapeutic Intervention in Diabetic Foot Ulcers.","finding":"","journal":"ACS pharmacology & translational science","studyType":"Clinical Study"},{"pmid":"38281321","year":"2024","title":"Laminin mimetic angiogenic and collagen peptide hydrogel for enhance dermal wound healing.","finding":"","journal":"Biomaterials advances","studyType":"Clinical Study"},{"pmid":"38279304","year":"2024","title":"Kick-Starting Wound Healing: A Review of Pro-Healing Drugs.","finding":"","journal":"International journal of molecular sciences","studyType":"Clinical Study"}],"tags":[{"label":"Human Platelet-derived Growth Factor","category":"class"},{"label":"Small Molecule","category":"modality"},{"label":"Platelet-derived growth factor receptor","category":"target"},{"label":"PDGFRA","category":"gene"},{"label":"PDGFRB","category":"gene"},{"label":"A01AD08","category":"atc"},{"label":"Topical","category":"route"},{"label":"Gel","category":"form"},{"label":"Active","category":"status"},{"label":"Neuropathic diabetic ulcer - foot","category":"indication"},{"label":"Omj Pharmaceuticals","category":"company"},{"label":"Approved 1990s","category":"decade"},{"label":"Angiogenesis Inducing Agents","category":"pharmacology"},{"label":"Anticoagulants","category":"pharmacology"},{"label":"Growth Substances","category":"pharmacology"},{"label":"Hematologic Agents","category":"pharmacology"}],"phase":"marketed","safety":{"safetySignals":[{"llr":444.285,"date":"","count":74,"signal":"Wound complication","source":"DrugCentral FAERS","actionTaken":"Reported 74 times (LLR=444)"},{"llr":244.849,"date":"","count":62,"signal":"Osteomyelitis","source":"DrugCentral FAERS","actionTaken":"Reported 62 times (LLR=245)"},{"llr":214.026,"date":"","count":38,"signal":"Toe amputation","source":"DrugCentral FAERS","actionTaken":"Reported 38 times (LLR=214)"},{"llr":132.56,"date":"","count":51,"signal":"Cellulitis","source":"DrugCentral FAERS","actionTaken":"Reported 51 times (LLR=133)"},{"llr":113.242,"date":"","count":14,"signal":"Application site infection","source":"DrugCentral FAERS","actionTaken":"Reported 14 times (LLR=113)"},{"llr":93.263,"date":"","count":20,"signal":"Application site pain","source":"DrugCentral FAERS","actionTaken":"Reported 20 times (LLR=93)"},{"llr":72.179,"date":"","count":15,"signal":"Wound infection staphylococcal","source":"DrugCentral FAERS","actionTaken":"Reported 15 times (LLR=72)"},{"llr":58.149,"date":"","count":19,"signal":"Wound infection","source":"DrugCentral FAERS","actionTaken":"Reported 19 times (LLR=58)"},{"llr":57.663,"date":"","count":15,"signal":"Gangrene","source":"DrugCentral FAERS","actionTaken":"Reported 15 times (LLR=58)"},{"llr":57.636,"date":"","count":14,"signal":"Wound secretion","source":"DrugCentral FAERS","actionTaken":"Reported 14 times (LLR=58)"},{"llr":51.462,"date":"","count":15,"signal":"Incorrect product administration duration","source":"DrugCentral FAERS","actionTaken":"Reported 15 times (LLR=51)"},{"llr":50.349,"date":"","count":29,"signal":"Inappropriate schedule of product administration","source":"DrugCentral FAERS","actionTaken":"Reported 29 times (LLR=50)"},{"llr":49.923,"date":"","count":9,"signal":"Foot amputation","source":"DrugCentral FAERS","actionTaken":"Reported 9 times (LLR=50)"},{"llr":49.59,"date":"","count":9,"signal":"Application site discolouration","source":"DrugCentral FAERS","actionTaken":"Reported 9 times (LLR=50)"}],"commonSideEffects":[{"effect":"Erythematous rashes","drugRate":"2%","severity":"common","organSystem":""},{"effect":"Burning sensation at application site","drugRate":"","severity":"common","organSystem":""},{"effect":"Erythema at application site","drugRate":"","severity":"common","organSystem":""}],"specialPopulations":{"Lactation":"There are no data on the presence of becaplermin in human milk, the effects on the breastfed infant, or the effects on milk production after topical application of REGRANEX to lactating women. The developmental and health benefits of breastfeeding should be considered along with the lactating womans clinical need for REGRANEX and any potential adverse effects on the breastfed child from becaplermin.","Pregnancy":"There are no available data on REGRANEX use in pregnant women to inform drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. Animal reproduction studies have not been conducted with REGRANEX.The background risk of major birth defects and miscarriage for the indicated population is unknown. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.","Geriatric use":"Among subjects receiving any dose of REGRANEX in clinical studies of diabetic lower extremity ulcers, 150 subjects were 65 years of age and over. No overall differences in safety or effectiveness were observed between these subjects and younger subjects. The number of subjects aged 75 and older was insufficient (n=34) to determine whether they respond differently from younger subjects.","Paediatric use":"Safety and effectiveness of REGRANEX in pediatric patients below the age of 16 years have not been established."},"seriousAdverseEvents":[{"effect":"Cancer (systemic malignancies)","drugRate":"2.7%","severity":"serious"},{"effect":"Death from systemic malignancies","drugRate":"","severity":"serious"}]},"trials":[],"aliases":[],"company":"Omj Pharmaceuticals","patents":[],"pricing":[],"_sources":{"trials":{"url":"https://clinicaltrials.gov/search?intr=BECAPLERMIN","method":"api_direct","source":"ClinicalTrials.gov","rawText":"","confidence":1,"sourceType":"ctgov","retrievedAt":"2026-04-20T00:09:31.371070+00:00"},"regulatory.ca":{"url":"","method":"api_direct","source":"Health Canada 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signaling cascade that promotes cellular growth and proliferation."},"commercial":{"launchDate":"1997","_launchSource":"DrugCentral (FDA 1997-12-16, OMJ PHARMACEUTICALS)"},"references":[{"id":1,"url":"https://drugcentral.org/drugcard/4925","fields":["approvals","synonyms","ATC","PK","indications","contraindications","DDIs","targets","patents","FAERS"],"source":"DrugCentral"},{"id":2,"url":"https://clinicaltrials.gov/search?intr=BECAPLERMIN","fields":["trials"],"source":"ClinicalTrials.gov"},{"id":3,"url":"https://pubmed.ncbi.nlm.nih.gov/?term=BECAPLERMIN","fields":["publications"],"source":"PubMed/NCBI"}],"_enrichedAt":"2026-03-30T08:49:40.594161","_validation":{"fieldsValidated":0,"lastValidatedAt":"2026-04-20T00:09:39.203559+00:00","fieldsConflicting":2,"overallConfidence":0.8},"biosimilars":[{"form":"GEL","route":"TOPICAL","company":"Smith & Nephew, 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