Sorilux

(calcipotriene)

ApprovedSmall molecule

LEO Pharma

Sorilux is one of 87 small molecule programs targeting Psoriasis. It is currently in Approved.

Indications

Total Trials

Active Trials

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Patents

Pipeline

Status by Indication[3][1]

Indication

PsoriasisActive, not recruiting

FluorouracilRecruiting

Transplant RecipientActive, not recruiting

Atopic DermatitisNot yet recruiting

PsoriasisApproved

Active, not recruiting

FluorouracilPhase 1

Recruiting

Transplant RecipientPhase 2

Active, not recruiting

Atopic DermatitisApproved

Not yet recruiting

Competition

Competitive Landscape

127 competitors in Atopic Dermatitis

#DrugCompanyPhaseTrials

Sorilux

LEO Pharma

Approved

1 2

Cytosar

Teva

Phase 3

1 3

Fludara

Sanofi

Phase 3

1 4

Adtralza

LEO Pharma

Phase 3

16 5

Amlitelimab

Sanofi

Phase 3

2 6

Certolizumab

Johnson & Johnson

Phase 3

1 7

DUPIXENT

Regeneron

Phase 3

1 8

Jaktinib

SSuzhou Zelgen Biopharmaceuticals Co.,Ltd

Phase 3

4 9

ICP-332

BBeijing InnoCare Pharma Tech Co., Ltd.

Phase 3

2 10

VC005

JJiangsu vcare pharmaceutical technology co., LTD

Phase 3

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

Timeline

Expected Milestones

Q4 2026

Phase 1Recruiting

Fluorouracil

NCT03370406

Q1 2029

Phase 2Active, not recruiting

Transplant Recipient

NCT05699603

Q2 2030

Post-ApprovalNot yet recruiting

Atopic Dermatitis

NCT07352566

Clinical

Trials by Indication[1]

Psoriasis Vulgaris2 trials

A 12-Day Randomized, Blinded, Vehicle and Active Comparator-Controlled Study to Determine the Efficacy and Safety of Six Concentrations of Topical E6201 Gel in Subjects With Psoriasis Vulgaris

Completed· Eisai logo

Eisai·Phase 2·NCT01268527·30 enrolled

LEO 80185 in the Treatment of Psoriasis Vulgaris on the Non-scalp Regions of the Body (Trunk and/or Limbs)

Completed· LEO Pharma logo

LEO Pharma·Phase 3·NCT01188928·1,152 enrolled

Psoriasis2 trials

Olux E Foam and Sorilux Foam Combination Therapy for the Maintenance of Treatment Response in Patients With Moderate Plaque Psoriasis

Completed·UUnknown Sponsor·Phase 4·NCT01745133·63 enrolled

Safety, Tolerability and Efficacy of SNA-120 for Treatment of Pruritus and Psoriasis in Subjects Treated With Calcipotriene

Completed·SSienna Biopharmaceuticals·Phase 2·NCT03448081·73 enrolled

Clinical Trial1 trial

"Clinical Trial to Determine the Efficacy of Vitamin D for Acne Therapy"

Completed·UUniversity of California, Los Angeles·Phase 2/3·NCT01694433·66 enrolled

Effectiveness1 trial

Comparative Effectiveness Trial in the Treatment of Pediatric Plaque Morphea

Withdrawn·MMedical College of Wisconsin·Phase 1·NCT02680717

Breast Cancer1 trial

Topical Calcipotriene Treatment for Breast Cancer Immunoprevention

Terminated·MMassachusetts General Hospital·Phase 1·NCT03596073·43 enrolled

3 more indications

Fluorouracil1 trial

Intralesional 5-Fluorouracil (5FU), Topical Calcipotriene Treatment for SCC

Recruiting·MMelissa Pugliano-Mauro·Phase 1·NCT03370406·30 enrolled

Atopic Dermatitis1 trial

Utilization of a Microdevice for Psoriasis and Atopic Dermatitis

Not yet recruiting·UUniversity of California, San Francisco·Phase 4·NCT07352566·10 enrolled

Transplant Recipient1 trial

Testing the Efficacy of Topical Calcipotriene Plus 5-Fluorouracil Combination to Activate the Immune System Against Precancerous Skin Lesions in Organ Transplant Recipients

Active, not recruiting·UUniversity of Arizona·Phase 2·NCT05699603·56 enrolled

Regulatory

FDA Approval Timeline[4]

Dec 29, 1993

DOVONEX

NDA NDA020273

Jul 22, 1996

DOVONEX

NDA NDA020554

Mar 3, 1997

DOVONEX

NDA NDA020611

Oct 6, 2010

SORILUX

NDA NDA022563

Sources

References

[1]
ClinicalTrials.gov — 10 trial records for calcipotriene. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — calcipotriene compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for calcipotriene. EMBL-EBI & Wellcome Sanger Institute.
[4]
OpenFDA — FDA approval records (NDA NDA022563). U.S. Food & Drug Administration.
[5]
FDA Orange Book — Patent and exclusivity data for Sorilux. U.S. Food & Drug Administration.
[6]
SEC EDGAR — LEO Pharma company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Highest Phase: Approved[1]
Company: LEO Pharma

Patent Landscape[5]

Patent Cliff

May 7, 2028

Earliest patent expiration — generic entry possible after this date

Patent #Expires

8629128May 26, 2026

8263580May 7, 2028

Sorilux

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q4 2026

Q1 2029

Q2 2030

Trials by Indication[1]

Psoriasis Vulgaris2 trials

Psoriasis2 trials

Clinical Trial1 trial

Effectiveness1 trial

Breast Cancer1 trial

Fluorouracil1 trial

Atopic Dermatitis1 trial

Transplant Recipient1 trial

FDA Approval Timeline[4]

References

Drug Info

Quick Facts

Patent Landscape[5]

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