{
 "query": "clascoterone",
 "ingredient": "clascoterone",
 "slug": "clascoterone",
 "rxcui": "2474340",
 "brands": [
  "Winlevi"
 ],
 "names": [
  "clascoterone"
 ],
 "classes": [],
 "alternatives": [],
 "label": {
  "route_mode": "TOPICAL",
  "route_counts": {
   "TOPICAL": 1
  },
  "boxed_warning": "",
  "indications_and_usage": "(clascoterone) cream is an androgen receptor inhibitor indicated for the topical treatment of acne vulgaris in patients 12 years of age and older. WINLEVI (clascoterone) cream is an androgen receptor inhibitor indicated for the topical treatment of acne vulgaris in patients 12 years of age and older. ( 1 )",
  "contraindications": "None. None ( 4 )",
  "warnings_and_cautions": "Local Irritation: Pruritus, burning, skin redness or peeling may be experienced with WINLEVI cream. If these effects occur, discontinue or reduce the frequency of application of WINLEVI cream. ( 5.1 ) Hypothalamic-pituitary-adrenal (HPA) axis suppression may occur during or after treatment with clascoterone. ( 5.2 ) Attempt to withdraw use if HPA axis suppression develops. ( 5.2 ) Pediatric patients may be more susceptible to systemic toxicity. ( 5.2 , 8.4 ) Hyperkalemia: Elevated potassium levels were observed in some subjects during the clinical trials. ( 12.2 ) 5.1 Local Skin Reactions WINLEVI cream may induce local irritation (erythema/redness, pruritus, scaling/ dryness). Concomitant use with other potentially irritating topical products (medicated or abrasive soaps and cleansers, soaps and cosmetics that have a strong drying effect and products with high concentrations of alcohol, astringents, spices or lime) should be limited. The product should not be applied to cuts, abrasions, eczematous or sunburned skin. 5.2 Hypothalamic-pituitary-adrenal (HPA) Axis Suppression Hypothalamic-pituitary-adrenal (HPA) axis suppression was observed and may occur during or after treatment wit...",
  "warnings": "",
  "adverse_reactions": "Most common adverse reactions occurring in 7 to 12% of patients are erythema/reddening, pruritus and scaling/dryness. Additionally, edema, stinging, and burning occurred in >3% of patients and were reported in a similar percentage of subjects treated with vehicle. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Sun Pharmaceutical Industries, Inc. 1-800-818-4555 or FDA at 1-800-FDA-1088 or http://www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. In two identical multicenter, randomized, double-blind, vehicle-controlled trials, 1421 subjects 12 years and older with facial acne vulgaris applied WINLEVI cream or vehicle twice daily for 12 weeks. Overall, 62% of the subjects were female, and 38% were male, 91% of the patients were Caucasian, and the mean age was 19.7 years. Local skin reactions (edema, erythema/redness, pruritus, scaling/dryness, skin atrophy, stinging/burning, striae rubrea, telangiectasia) were obse...",
  "drug_abuse_and_dependence": "",
  "controlled_substance": "",
  "recent_major_changes": "",
  "information_for_patients": "Advise the patient to read the FDA-approved patient labeling (Patient Information). Avoid applying WINLEVI Cream to damaged skin (such as cuts, abrasions), eczematous areas, and sunburned skin. Avoid concomitant use of other potentially irritating topical products (medicated or not).",
  "spl_medguide": "",
  "clinical_studies": "The safety and efficacy of WINLEVI cream 1% applied twice daily for 12 weeks for the treatment of acne vulgaris were assessed in two identically-designed, multicenter, randomized, double-blind, vehicle-controlled clinical trials (Trial 1 [NCT02608450] and Trial 2 [NCT02608476]) enrolling 1440 subjects with facial acne vulgaris. The trials enrolled subjects 9 years or older with Investigator's Global Assessment (IGA) of moderate or severe facial acne vulgaris (score of 3 or 4), 30 to 75 inflammatory lesions (papules, pustules and nodules), and 30 to 100 non-inflammatory lesions (open and closed comedones). A total of 1421 subjects 12 years and older with facial acne vulgaris were enrolled. Of these subjects, 641 (45%) were 12 to 17 years of age, and 780 (55%) were 18 years of age or older. In addition, 62% of the subjects were female, and 91% were Caucasian. At baseline, subjects had a mean inflammatory lesion count of 42.4 and a mean non-inflammatory lesion count of 61.4. Additionally, approximately 83% of subjects had an IGA score of 3 (\"moderate\"). Efficacy was assessed at Week 12 by the proportion of subjects in each treatment group with at least a 2-point reduction in IGA compa...",
  "brand_name": "Winlevi",
  "manufacturer": "Sun Pharmaceutical Industries, Inc.",
  "application_number": "NDA213433",
  "pharm_class_epc": [
   "Androgen Receptor Inhibitor [EPC]"
  ],
  "route": [
   "TOPICAL"
  ],
  "effective_time": "20250102",
  "set_id": "1673a84b-7f5c-47ab-a99c-1e3db21a6a09",
  "has_boxed_warning": false,
  "controlled": false,
  "mentions_rems": false
 },
 "faers": {
  "total": 1418,
  "serious": 75,
  "death": 0,
  "hospitalization": 6,
  "primary_suspect": 1416,
  "top_reactions": [
   [
    "Product Storage Error",
    333
   ],
   [
    "Product Physical Consistency Issue",
    329
   ],
   [
    "Product Use Complaint",
    286
   ],
   [
    "Product Dose Omission Issue",
    184
   ],
   [
    "Product Use Issue",
    153
   ],
   [
    "Drug Ineffective",
    146
   ],
   [
    "Therapy Cessation",
    86
   ],
   [
    "Poor Quality Product Administered",
    84
   ],
   [
    "Product Physical Issue",
    78
   ],
   [
    "Condition Aggravated",
    76
   ],
   [
    "Product Quality Issue",
    67
   ],
   [
    "Acne",
    46
   ],
   [
    "Off Label Use",
    38
   ],
   [
    "Erythema",
    30
   ],
   [
    "Liquid Product Physical Issue",
    25
   ]
  ],
  "by_year": {
   "2021": 4,
   "2022": 500,
   "2023": 210,
   "2024": 422,
   "2025": 269,
   "2026": 13
  },
  "by_year_primary": {
   "2021": 4,
   "2022": 500,
   "2023": 209,
   "2024": 422,
   "2025": 269,
   "2026": 12
  }
 },
 "faers_base": {
  "total": 20692304,
  "serious_share": 0.5742697381596559,
  "death_share": 0.09102355155810585
 },
 "recalls": [],
 "recall_total": 0,
 "drugsfda": {
  "applications": 1,
  "nda": 1,
  "anda": 0,
  "first_approval": "20200826",
  "rems": false,
  "rems_last": "",
  "labeling_supplements": 1,
  "labeling_recent": 1,
  "sponsors": [
   "SUN PHARM"
  ],
  "unapproved": false,
  "first_approval_fmt": "08/26/2020"
 },
 "trials": {
  "total": 24,
  "completed": 15,
  "terminated": 0,
  "with_results": 11,
  "industry": 19,
  "phase3": 7,
  "results_share": 0.7333333333333333,
  "terminated_share": 0.0
 },
 "pubmed": {
  "rct": 8,
  "meta": 2,
  "recent_rct": 6,
  "cochrane": []
 },
 "payments": {
  "year": "2024",
  "usd": 720430.57,
  "records": 16366,
  "by_name": [
   [
    "Winlevi",
    720430.57
   ]
  ],
  "names_checked": [
   "clascoterone",
   "Winlevi"
  ],
  "source": "bulk-index"
 },
 "partd": {
  "year": "2024",
  "claims": 1883,
  "beneficiaries": 809,
  "spend": 1120072.72,
  "by_brand": [
   {
    "brand": "Winlevi",
    "claims": 1883,
    "per_claim": 594.83415826,
    "is_generic": false
   }
  ],
  "per_claim": 594.8341582580988
 },
 "mdl": [],
 "dsc": [],
 "settlements": [],
 "prescrire": null,
 "eml": {
  "listed": false,
  "status": "",
  "name": "",
  "matched": null,
  "stewardship": []
 },
 "exposure": null,
 "scores": {
  "safety": {
   "score": 100,
   "letter": "A",
   "why": [
    "Death share in reports is near or below the FAERS average (0.0x)"
   ],
   "weight": 0.35
  },
  "evidence": {
   "score": 29,
   "letter": "F",
   "why": [
    "8 randomized trials and 2 systematic reviews/meta-analyses indexed in PubMed",
    "No Cochrane review found (-5)"
   ],
   "weight": 0.25
  },
  "regulatory": {
   "score": 100,
   "letter": "A",
   "why": [
    "No recalls on record since 2016"
   ],
   "weight": 0.15
  },
  "conflict": {
   "score": 85,
   "letter": "B",
   "why": [
    "Pharma paid doctors $720,431 tied to this drug last year (-15)",
    "Not named in any pending federal MDL"
   ],
   "weight": 0.15
  },
  "options": {
   "score": 40,
   "letter": "F",
   "why": [
    "No generic version approved: brand-only pricing (-30)",
    "No same-class alternatives found: little leverage to switch (-30)"
   ],
   "weight": 0.1
  }
 },
 "total": 74,
 "grade": "C",
 "questions": [
  "The most-reported problems in FDA's adverse event data are product storage error, product physical consistency issue, product use complaint, product dose omission issue. How would we recognize and handle those?",
  "There is no generic. Is there an older generic in the same class that works as well for my situation?",
  "What result are we expecting, by when, and what is the plan if it does not happen?",
  "If 100 people like me took this drug, how many would actually get better because of it, and how many would be harmed by it? (Doctors call these the number needed to treat and the number needed to harm.)"
 ]
}