GALDERMA LABS LP
NDA · approvedNDA211527
Approved2019Studies4,253Trials343
Winlevi — FDA approval record and published evidence
SUN PHARM · Skin & Topicals · Topical clascoterone
NDA · approvedNDA213433
PathwayPathwayAn NDA is a new drug application. FDA approved the drug; approved, not cleared. The original approval can long predate any cosmetic indication, and Drugs@FDA does not publish a per-indication date.
Methodology →NDA · approved
Methodology →NDA · approved
ClassClassDevice class does not apply: this is a drug approved under a NDA, not a device.
Methodology →—
Methodology →—
First approved2020
Years on marketYears on marketDerived: the data run date minus the first matched FDA decision date. Arithmetic on a real date, nothing else.
Methodology →6
Methodology →6
StudiesStudiesPubMed records for a fixed query about the MODALITY, not the brand. It measures how much has been published about a technique. It is not a quality score, not an efficacy measure, not a count of randomised trials, and not comparable between modalities of different ages. It says nothing about this brand specifically.
Methodology →90
Methodology →90
TrialsTrialsClinicalTrials.gov studies for a fixed query about the MODALITY, not the brand. Registration is not completion, not publication and not a result. Counts include studies of any status, size or sponsor, and the recruiting figure is a snapshot taken on the run date. Device studies are under-registered relative to drug studies.
Methodology →21
Methodology →21
An NDA product is approved, not cleared — the drug route, not the device one. What this measuresAn NDA is a new drug application. FDA approved the drug; approved, not cleared. The original approval can long predate any cosmetic indication, and Drugs@FDA does not publish a per-indication date. It measures how much has been published about a technique. It is not a quality score, not an efficacy measure, not a count of randomised trials, and not comparable between modalities of different ages. It says nothing about this brand specifically.
Methodology →
Shares treatment areas — not a recommendation. What this measuresPicked mechanically, by rule and nothing else: products in the same Index category that share the most derived treatment areas with this one, ties broken alphabetically. Treatment areas are themselves derived by a published keyword rule run over a real source string, not copied from the cleared or approved indication, so a shared area means two products' source strings happened to use the same word. It does not mean the two products do the same job, it is not a claim that they are interchangeable, and it is not a recommendation.
Methodology →
Overview
- Modality
- Topical clascoterone
- Manufacturer
- SUN PHARM
- Category
- Skin & Topicals
- Latest decision
- FDA records
- 1
- Mapping
- Verified
Mapping is the weakest link on this page; the rule is published. What this measuresMatched openFDA Drugs@FDA application NDA213433 (NDA). first_decision_date is the ORIGINAL approved submission; latest_decision_date is the most recent approved submission of any type (including supplements for new indications). NOTE: the original approval may predate the COSMETIC indication -- Drugs@FDA does not expose per-indication dates, so this file does not claim one. A mapping is the weakest link on this page: if it is wrong, every number above it is about the wrong product. It is stated in full so it can be checked.
Methodology →
Regulatory
| Identifier | Type | Role | FDA record |
|---|---|---|---|
| NDA213433 | NDA — approved | Primary | Open → |
Approved indication: not transcribed here — read it on NDA213433 → Approved indicationopenFDA's release of this database does not return the indications-for-use text, and this Index will not paraphrase a regulatory statement it has not transcribed. An NDA is a new drug application. FDA approved the drug; approved, not cleared. The original approval can long predate any cosmetic indication, and Drugs@FDA does not publish a per-indication date.
Methodology →
Evidence
Counted for the modality, never the brand.
90PubMed, all time
88PubMed, 10y
21Studies
2Recruiting
| Topical clascoterone | |
|---|---|
| 2016 | 0 |
| 2017 | 1 |
| 2018 | 1 |
| 2019 | 5 |
| 2020 | 6 |
| 2021 | 12 |
| 2022 | 6 |
| 2023 | 12 |
| 2024 | 18 |
| 2025 | 21 |
| 2026 | 14 |
21papers · 2025 · modality, not brand+17%
PubMed counts publications; ClinicalTrials.gov counts registrations. Neither is a quality score. What this measuresPubMed record counts and ClinicalTrials.gov study counts for a fixed query about the MODALITY, never the brand. It measures how much has been published about a technique. It is not a quality score, not an efficacy measure, not a count of randomised trials, and not comparable between modalities of different ages. It says nothing about this brand specifically. Registration is not completion, not publication and not a result. Counts include studies of any status, size or sponsor, and the recruiting figure is a snapshot taken on the run date. Device studies are under-registered relative to drug studies. The trend line is the same fixed modality query windowed per publication year. Number of PubMed records matching each modality's fixed, hand-written title/abstract query, windowed to a single publication year. It measures publication volume about a TECHNIQUE, not a brand. It is NOT a quality score, NOT an efficacy measure, and NOT a count of randomised trials. 2026 is a partial year (run date 2026-07-26); its bar is short because the year is short, not because interest fell. 2026 contains only papers indexed by the run date (2026-07-26). Render it visually distinct (e.g. hollow/hatched) or annotate it; never let it read as a decline.
Methodology →
PubMed query, verbatim
(clascoterone[tiab] OR "cortexolone 17"[tiab] OR "androgen receptor inhibitor"[tiab]) AND (acne[tiab] OR skin[tiab] OR cutaneous[tiab] OR "androgenetic alopecia"[tiab])
ClinicalTrials.gov query, verbatim
intervention: (clascoterone OR "cortexolone 17 alpha-propionate") condition: ("acne vulgaris" OR acne OR "androgenetic alopecia" OR skin)
Treatment areas
What matched, and where
| Area | Matched term | Source string |
|---|---|---|
| Acne | acne | ClinicalTrials.gov condition query for Topical clascoterone |
| Hair growth | alopecia | ClinicalTrials.gov condition query for Topical clascoterone |
Derived by keyword rule, not the cleared or approved indication. What this measuresTreatment areas are DERIVED, not copied from an FDA field. A fixed keyword list is run over two real strings: the ClinicalTrials.gov condition query actually executed for this product's modality on the run date, and the device names of the FDA product codes attached to this product's records. The words "skin" and "cosmetic" are ignored because every query contains one of them. An area is not the cleared or approved indication — openFDA's 510(k) response does not carry the indications-for-use text, and this Index does not paraphrase it.
Methodology →
Sources
- openFDA query run for this producthttps://api.fda.gov/drug/drugsfda.json?search=openfda.brand_name:%22WINLEVI%22&limit=10
- FDA public record for NDA213433https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=213433
- PubMed count, all timehttps://eutils.ncbi.nlm.nih.gov/entrez/eutils/esearch.fcgi?db=pubmed&retmode=json&rettype=count&term=%28clascoterone%5Btiab%5D%20OR%20%22cortexolone%2017%22%5Btiab%5D%20OR%20%22androgen%20receptor%20inhibitor%22%5Btiab%5D%29%20AND%20%28acne%5Btiab%5D%20OR%20skin%5Btiab%5D%20OR%20cutaneous%5Btiab%5D%20OR%20%22androgenetic%20alopecia%22%5Btiab%5D%29
- PubMed count, last 10 yearshttps://eutils.ncbi.nlm.nih.gov/entrez/eutils/esearch.fcgi?db=pubmed&retmode=json&rettype=count&term=%28clascoterone%5Btiab%5D%20OR%20%22cortexolone%2017%22%5Btiab%5D%20OR%20%22androgen%20receptor%20inhibitor%22%5Btiab%5D%29%20AND%20%28acne%5Btiab%5D%20OR%20skin%5Btiab%5D%20OR%20cutaneous%5Btiab%5D%20OR%20%22androgenetic%20alopecia%22%5Btiab%5D%29%20AND%20%28%222016%2F01%2F01%22%5Bdp%5D%20%3A%20%222026%2F12%2F31%22%5Bdp%5D%29
- ClinicalTrials.gov, all studieshttps://clinicaltrials.gov/api/v2/studies?query.intr=%28clascoterone%20OR%20%22cortexolone%2017%20alpha-propionate%22%29&query.cond=%28%22acne%20vulgaris%22%20OR%20acne%20OR%20%22androgenetic%20alopecia%22%20OR%20skin%29&countTotal=true&pageSize=1&fields=NCTId
- ClinicalTrials.gov, recruiting onlyhttps://clinicaltrials.gov/api/v2/studies?query.intr=%28clascoterone%20OR%20%22cortexolone%2017%20alpha-propionate%22%29&query.cond=%28%22acne%20vulgaris%22%20OR%20acne%20OR%20%22androgenetic%20alopecia%22%20OR%20skin%29&filter.overallStatus=RECRUITING&countTotal=true&pageSize=1&fields=NCTId
No adverse-event data is published anywhere on this site. What this measuresNo adverse-event data appears anywhere on this site. MAUDE and FAERS were never queried: those counts have no denominator, reporting is voluntary and duplicated, and a report is not evidence of causation. Publishing them beside a brand name would mislead.
Methodology →