Leqselvi

(Deuruxolitinib)

Phase 3Small molecule

Sun Pharmaceutical Industries, Inc.

Leqselvi is one of 33 small molecule programs targeting Alopecia Areata. 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

Alopecia AreataRecruiting

Alopecia AreataPhase 3

Recruiting

Competition

Competitive Landscape

35 competitors in Alopecia Areata

#DrugCompanyPhaseTrials

Trexall

Jazz Pharmaceuticals

Approved

3 2

Otezla

Amgen

Approved

2 3

Kenalog

BBausch Health Americas, Inc.

Approved

11 4

Zolymbus

AbbVie

Approved

1 5

Daliresp

AstraZeneca

Approved

1 6

Xeljanz

PPrism Pharmaceuticals

Approved

8 7

Anzupgo

Jazz Pharmaceuticals

Approved

—8

Aspercreme Warming

AAveritas Pharma, Inc.

Approved

1 9

Zocor

OOrganon and Co

Approved

1 10

Xalatan

PPfizer's Upjohn has merged with Mylan to form Viatris Inc.

Approved

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

Timeline

Expected Milestones

Q2 2028

Phase 3Recruiting

Alopecia Areata

NCT07133308

Q3 2028

Phase 3Recruiting

Alopecia Areata

NCT07617597

Clinical

Trials by Indication[1]

Alopecia Areata2 trials

Study to Evaluate the Efficacy and Safety of Deuruxolitinib in Adolescents With Severe Alopecia Areata

Recruiting· Sun Pharmaceutical Industries, Inc. logo

Sun Pharmaceutical Industries, Inc.·Phase 3·NCT07133308·355 enrolled

A Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Deuruxolitinib in Adult Patients With Severe Alopecia Areata With an Open-Label Extension Period

Recruiting·SSun Pharma Japan Limited·Phase 3·NCT07617597·78 enrolled

Regulatory

FDA Approval Timeline[4]

Jul 25, 2024

LEQSELVI

NDA NDA217900

Sources

References

[1]
ClinicalTrials.gov — 2 trial records for Deuruxolitinib. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Deuruxolitinib compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Deuruxolitinib. EMBL-EBI & Wellcome Sanger Institute.
[4]
OpenFDA — FDA approval records (NDA NDA217900). U.S. Food & Drug Administration.
[5]
FDA Orange Book — Patent and exclusivity data for Leqselvi. 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

May 4, 2037

Earliest patent expiration — generic entry possible after this date

Patent #Expires

10561659May 4, 2037

12076323May 4, 2037

11919907May 21, 2041

12285432Aug 11, 2042

12247034May 10, 2044

1 more patents

12364699Oct 10, 2044

Leqselvi

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q2 2028

Q3 2028

Trials by Indication[1]

Alopecia Areata2 trials

FDA Approval Timeline[4]

References

Drug Info

Quick Facts

Patent Landscape[5]

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