Soriatane

(Acitretin)

ApprovedSmall molecule

Acitretin is used to treat severe psoriasis, a skin condition that causes thick, scaly patches. It works by slowing down skin cell growth and reducing inflammation.[2] Soriatane is currently approved and in use across 9 indications[4].[1]

Soriatane is one of 249 small molecule programs targeting Alzheimer disease. It is currently in Approved.

Indications

Total Trials

Active Trials

248

Competitors

FDA Application

NDA/BLA/ANDA regulatory filings

Pipeline

Status by Indication[4][1]

Indication

Alzheimer DiseaseApproved

HIV InfectionApproved

Hidradenitis SuppurativaCompleted

Skin CancerActive, not recruiting

VitiligoActive, not recruiting

AmyloidosisActive, not recruiting

Psoriasis VulgarisUnknown status

PsoriasisTerminated

Skin RashWithdrawn

Alzheimer DiseaseApproved

Approved

HIV InfectionApproved

Approved

Hidradenitis SuppurativaApproved

Completed

Skin CancerPreclinical

Active, not recruiting

VitiligoPreclinical

Active, not recruiting

AmyloidosisApproved

Active, not recruiting

Psoriasis VulgarisApproved

Unknown status

PsoriasisApproved

Terminated

Skin RashApproved

Withdrawn

Competition

Competitive Landscape

123 competitors in HIV Infection

#DrugCompanyPhaseTrials

Soriatane

GSK

Approved

28 2

Zerit

KKaruna Therapeutics, Inc., a Bristol Myers Squibb company

Approved

13 3

Sustiva

KKaruna Therapeutics, Inc., a Bristol Myers Squibb company

Approved

10 4

Lialda

Takeda

Approved

1 5

Hepsera

Zofran

Cabenuva

Mycobutin

Viread

Tegretol

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

Timeline

Expected Milestones

Q4 2027

Post-ApprovalNot yet recruiting

Psoriasis

NCT04239859

Post-ApprovalRecruiting

Psoriasis

NCT04537689

Clinical

Trials by Indication[1]

Psoriasis14 trials

Efficacy and Safety of Acitretin Plus Pioglitazone in Patients With Psoriasis

Completed·PPost Graduate Institute of Medical Education and Research, Chandigarh·Phase 2·NCT00395941·40 enrolled

Study Evaluating the Efficacy and Safety of Etanercept and Acitretin in Korean Patient With Moderate to Severe Psoriasis

Completed· Pfizer logo

Pfizer·Phase 4·NCT00936065·60 enrolled

Evaluation of the Efficacy of Acitretin Therapy for Nail Psoriasis

Completed·IIstituti Fisioterapici Ospitalieri·Phase 4·NCT00723437·36 enrolled

Show 11 more trials

Economic Evaluation of Systemic Treatments for Moderate-to-severe Psoriasis

Completed·JJochen Schmitt.··NCT01812954·1 enrolled

Acitretin and Etanercept in Psoriasis

Completed·UUniversity of Medicine and Dentistry of New Jersey·Phase 2·NCT00156247·10 enrolled

Outcomes With Treatment and Withdraw of Ixekizumab in Patients With Plaque Psoriasis

Recruiting·SSingapore General Hospital·Phase 4·NCT04537689·40 enrolled

Dose Ranging Study to Assess the Efficacy and Safety of Acitretin in Severe Plaque Type Psoriasis

Completed·PPost Graduate Institute of Medical Education and Research, Chandigarh·Phase 4·NCT01039142·61 enrolled

Trial of an Injectable Biologic and U0279 as Combination Therapy for Severe Plaque-Type Psoriasis

Withdrawn· GSK logo

GSK·Phase 4·NCT00832364

Efficacy and Safety Study of Total Glucosides of Paeony Combined With Acitretin to Treat Psoriasis

Completed·XXijing Hospital·N/A·NCT02191020·108 enrolled

Acitretin or Tazarotene Gel and Excimer Laser for Treatment of Psoriasis

Terminated·UUniversity of Utah·N/A·NCT01094717·13 enrolled

Treatment of Psoriasis Using Acitretin in HIV-Positive Patients

Completed· Roche logo

Roche·Phase 3·NCT00002143·30 enrolled

Comparative Effectiveness of Psoriasis Treatments on Systemic Inflammation

Completed·UUniversity Hospitals Cleveland Medical Center··NCT02330380·26 enrolled

Addition of Excimer Laser to Treatment With Acitretin Tablets for Psoriasis of the Palms and Soles

Terminated·IIcahn School of Medicine at Mount Sinai·Phase 4·NCT02181790·2 enrolled

Outcomes With Treatment and Withdraw of Secukinumab in Patients With Plaque Psoriasis

Not yet recruiting·SSingapore General Hospital·Phase 4·NCT04239859·40 enrolled

Skin Cancer2 trials

Acitretin in Preventing Skin Cancer in Patients at High Risk for Skin Cancer

Completed·MMayo Clinic·N/A·NCT00644384·130 enrolled

Acitretin in Preventing Skin Cancers in Patients With Previously Treated Skin Cancers Who Have Undergone Organ Transplantation

Completed·AAlliance for Clinical Trials in Oncology·N/A·NCT00003611·129 enrolled

Psoriasis Vulgaris2 trials

Study Evaluating the Efficacy and Safety of Triptergium Wilfordii and Acitretin in Psoriasis Vulgaris - CHINA201002016-2

Unknown status·MMinistry of Health, China·Phase 4·NCT01443338·720 enrolled

Pharmacogenomics Study on Treatment of Psoriasis Vulgaris by Acitretin Capsules

Unknown status·—·Phase 2·NCT02715960·500 enrolled

Alzheimer's Disease1 trial

Alzheimer's Disease Acitretin Medication

Completed·UUnknown Sponsor·Phase 2·NCT01078168·22 enrolled

TED1 trial

Omentin-1 Level in Psoriatic Patients Treated With Narrowband Ultraviolet B Phototherapy Versus Acitretin

Completed·MMahmoud Ahmed Ali Ahmed·Phase 4·NCT05203354·60 enrolled

8 more indications

Vitiligo1 trial

Combined Effect of Acitretin and Narrow Band Ultraviolet B on Vitiligo Repigmentation

Unknown status·—·N/A·NCT04245319·20 enrolled

Amyloidosis1 trial

A Prospective Cohort Study on Primary Cutaneous Amyloidosis

Recruiting·—·Phase 4·NCT06998875·56 enrolled

Skin rash1 trial

Study of Acitretin to Treat Skin Rash Caused by Erlotinib (a Chemotherapy Drug)

Withdrawn·UUniversity of Pittsburgh·Phase 4·NCT01299220

Lichen Planus1 trial

Systemic Treatment Options for Generalized Lichen Planus

Not yet recruiting·SSheikh Zayed Medical College·Phase 2·NCT06739551·124 enrolled

Dermatitis1 trial

Pilot Study on the Use of Acitretin for the Treatment of Severe Chronic Hand Dermatitis

Completed·IInnovaderm Research Inc.·Phase 2/3·NCT01545284·9 enrolled

Melanoma1 trial

A Phase II Study of Vemurafenib Combined With Acitretin in Patients With Advanced Melanoma

Terminated·UUniversity of Arizona·Phase 2·NCT02050321·2 enrolled

Hidradenitis Suppurativa1 trial

Comparative Efficacy of Apremilast and Acitretin in Moderate-to-Severe Hidradenitis Suppurativa

Completed·HHayat Abad Medical Complex, Peshawar·Approved·NCT07708480·70 enrolled

Unspecified1 trial

RA Effect on Cell Surface Molecules in Vivo

Withdrawn·OOttawa Hospital Research Institute·Phase 1·NCT03753867

Regulatory

FDA Approval Timeline[5]

Oct 28, 1996

SORIATANE

NDA NDA019821

Sources

References

[1]
ClinicalTrials.gov — 28 trial records for Acitretin. U.S. National Library of Medicine, National Institutes of Health.
[2]
MedlinePlus Drug Information — Soriatane drug information. U.S. National Library of Medicine, National Institutes of Health.
[3]
ChEMBL — Acitretin compound record. European Bioinformatics Institute (EMBL-EBI).
[4]
Open Targets Platform — Drug–disease associations for Acitretin. EMBL-EBI & Wellcome Sanger Institute.
[5]
OpenFDA — FDA approval records (NDA NDA019821). U.S. Food & Drug Administration.
[6]
SEC EDGAR — GSK company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: Retinoid Receptor Agonist[3]
Modality: Small molecule[3]
Highest Phase: Approved[1]
Company: GSK

Soriatane

Status by Indication[4][1]

Competitive Landscape

Expected Milestones

Q4 2027

Trials by Indication[1]

Psoriasis14 trials

Skin Cancer2 trials

Psoriasis Vulgaris2 trials

Alzheimer's Disease1 trial

TED1 trial

Vitiligo1 trial

Amyloidosis1 trial

Skin rash1 trial

Lichen Planus1 trial

Dermatitis1 trial

Melanoma1 trial

Hidradenitis Suppurativa1 trial

Unspecified1 trial

FDA Approval Timeline[5]

References

Drug Info

Quick Facts

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