Winlevi

(Clascoterone)

Phase 3Small molecule

Sun Pharmaceutical Industries, Inc.

Winlevi is one of 48 small molecule programs targeting Efficacy and Safety. It is currently in Phase 3.

Indications

Total Trials

Active Trials

Competitors

FDA Application

NDA/BLA/ANDA regulatory filings

Patents

Pipeline

Status by Indication[3][1]

Indication

Efficacy and SafetyRecruiting

Efficacy and SafetyPhase 3

Recruiting

Competition

Competitive Landscape

228 competitors in Efficacy and Safety

#DrugCompanyPhaseTrials

Fludara

Sanofi

Phase 3

1 2

Tuoyi

SSun Yat-sen University

Phase 3

4 3

Busulfex

Akero Therapeutics

Phase 3

3 4

UPLIZNA

HHorizon Therapeutics Ireland DAC

Phase 3

1 5

Alka-Seltzer

AAbbott

Phase 3

1 6

Oxycontin

PPurdue Pharma LP

Phase 3

1 7

Tegoprazan

SShandong Luoxin Pharmaceutical Group Stock Co., Ltd.

Phase 3

4 8

Mitomycin C

GGynecologic Oncology Group

Phase 3

2 9

Avalglucosidase Alfa

Sanofi

Phase 3

1 10

Apatinib Mesylate

BBukwang Pharmaceutical

Phase 3

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Clinical

Trials by Indication[1]

Efficacy and Safety1 trial

Efficacy and Safety of Clascoterone Cream 1% in Facial Acne Vulgaris

Recruiting·ZZhejiang Sunshine Mandi Pharmaceutical Co.,Ltd.·Phase 3·NCT06403501·692 enrolled

Regulatory

FDA Approval Timeline[4]

Aug 26, 2020

WINLEVI

NDA NDA213433

Sources

References

[1]
ClinicalTrials.gov — 1 trial record for Clascoterone. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Clascoterone compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Clascoterone. EMBL-EBI & Wellcome Sanger Institute.
[4]
OpenFDA — FDA approval records (NDA NDA213433). U.S. Food & Drug Administration.
[5]
FDA Orange Book — Patent and exclusivity data for Winlevi. U.S. Food & Drug Administration.
[6]
SEC EDGAR — Sun Pharmaceutical Industries, Inc. company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Highest Phase: Phase 3[1]
Company: Sun Pharmaceutical Industries, Inc.

Patent Landscape[5]

Patent Cliff

Jan 12, 2027

Earliest patent expiration — generic entry possible after this date

Patent #Expires

8143240Jan 12, 2027

12337002Jul 24, 2028

9486458Jul 24, 2028

11938141Jul 24, 2028

10159682Aug 14, 2028

3 more patents

11207332Nov 20, 2028

9433628Feb 28, 2029

8785427Jul 25, 2030

Winlevi

Status by Indication[3][1]

Competitive Landscape

Trials by Indication[1]

Efficacy and Safety1 trial

FDA Approval Timeline[4]

References

Drug Info

Quick Facts

Patent Landscape[5]

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