Otezla

(Apremilast)

ApprovedSmall molecule

Apremilast is used to treat inflammatory skin conditions like psoriasis and psoriatic arthritis, as well as behçet's disease. It works by reducing inflammation and immune system overactivity that causes these conditions.[2] Otezla is currently approved and in use across 27 indications[4].[1]

Otezla is one of 365 small molecule programs targeting Recurrent aphthous stomatitis. It is currently in Approved.

Indications

129

Total Trials

Active Trials

364

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Patents

Pipeline

Status by Indication[4][1]

Indication

Recurrent Aphthous StomatitisCompleted

Psoriatic ArthritisUnknown status

Arthritis, PsoriaticCompleted

Immune System DiseaseActive, not recruiting

GoutApproved

Discoid Lupus ErythematosusApproved

Alcohol DependenceApproved

Atopic EczemaApproved

ProstatitisApproved

AcneApproved

Recurrent Aphthous StomatitisApproved

Completed

Psoriatic ArthritisApproved

Unknown status

Arthritis, PsoriaticApproved

Completed

Immune System DiseaseApproved

Active, not recruiting

GoutApproved

Approved

Discoid Lupus ErythematosusApproved

Approved

Alcohol DependenceApproved

Approved

Atopic EczemaApproved

Approved

ProstatitisApproved

Approved

AcneApproved

Approved

Showing 10 of 26 indications

Competition

Competitive Landscape

317 competitors in COVID-19

#DrugCompanyPhaseTrials

Otezla

Amgen

Approved

2 2

Nexavar

Bayer

Preclinical

1 3

Nitrostat

VViatris Specialty LLC

Preclinical

1 4

Benadryl

PParkedale

Preclinical

1 5

Statin

Bristol-Myers Squibb

Preclinical

1 6

Biological Data

UUniversity Hospital, Bordeaux

Preclinical

3 7

Aprotinin

Bayer

Preclinical

1 8

Piperacillin/tazobactam

Pfizer

Preclinical

1 9

Orap

Teva

Preclinical

1 10

Hymecromone

SStanford University

Preclinical

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

Timeline

Expected Milestones

Q4 2026

Phase 3Active, not recruiting

Psoriatic Arthritis

NCT04908189

Phase 3Recruiting

Recurrent Aphthous Stomatitis

NCT04227314

PreclinicalNot yet recruiting

Psoriatic Arthritis

NCT07398651

Q3 2027

Phase 2Not yet recruiting

Alcohol Use Disorder

NCT07325266

Q4 2027

Recruiting

Psoriasis

NCT05744466

Q1 2028

Phase 3Recruiting

Pneumonia

NCT02735707

Clinical

Trials by Indication[1]

Psoriasis41 trials

A Phase 3B, Open-label, Single-arm Study of the Efficacy and Safety of Apremilast, in Subjects With Plaque Psoriasis That is Not Adequately Controlled by Topical Therapy

Completed· Amgen logo

Amgen·Phase 3·NCT03930186·152 enrolled

A Study to Investigate Efficacy and Safety of Apremilast 30 mg Twice Daily (BID) in Chinese Participants With Moderate to Severe Plaque-type Psoriasis (PsO)

Completed· Amgen logo

Amgen·Phase 3·NCT06122649·203 enrolled

Effectiveness and Safety of BMS-986165 Compared to Placebo and Active Comparator in Participants With Psoriasis

Completed· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 3·NCT03624127·666 enrolled

Show 38 more trials

A Study of the Efficacy and Safety of Apremilast (CC-10004) in Subjects With Moderate to Severe Plaque Psoriasis of the Scalp

Completed· Amgen logo

Amgen·Phase 3·NCT03123471·303 enrolled

Vascular Inflammation in Psoriasis - Apremilast

Completed·UUniversity of Pennsylvania·Phase 4·NCT03082729·70 enrolled

A Study of the Comparative Effectiveness of Deucravacitinib in Adults With Plaque Psoriasis in Japan (RePhlect)

Recruiting· Bristol-Myers Squibb logo

Bristol-Myers Squibb··NCT06382987·600 enrolled

Study to Evaluate Safety and Effectiveness of Oral Apremilast (CC-10004) in Patients With Moderate to Severe Plaque Psoriasis

Completed· Amgen logo

Amgen·Phase 3·NCT01194219·844 enrolled

Monocyte Biomarkers in Moderate to Severe Plaque Psoriasis Subjects Treated With Apremilast

Completed·UUniversity Hospitals Cleveland Medical Center·Phase 2·NCT03442088·28 enrolled

A Study of Safety, Tolerability and Pharmacokinetics of Apremilast (CC-10004) in Pediatric Subjects With Moderate to Severe Plaque Psoriasis

Completed· Amgen logo

Amgen·Phase 2·NCT02576678·42 enrolled

A Study About How Well TAK-279 Works and Its Safety in Participants With Moderate-to-severe Plaque Psoriasis During 60 Weeks of Treatment With a Withdrawal and Retreatment Period

Completed· Takeda logo

Takeda·Phase 3·NCT06108544·1,108 enrolled

Quality of Life and Ultrasonographic Assessment of Nail Psoriasis After Treatment With Apremilast (JUST Study)

Completed·HHospital de Granollers··NCT03616561·45 enrolled

A Study of the Real-life Management of Psoriasis Patients Treated With Otezla® (Apremilast) in Belgium

Completed· Amgen logo

Amgen··NCT03097003·124 enrolled

A Real-world Observational Study to Compare Effectiveness of Deucravacitinib Vs Apremilast in Adults With Plaque Psoriasis

Recruiting· Bristol-Myers Squibb logo

Bristol-Myers Squibb··NCT05744466·1,500 enrolled

An Investigational Study to Evaluate Experimental Medication BMS-986165 Compared to Placebo and a Currently Available Treatment in Participants With Moderate-to-Severe Plaque Psoriasis

Completed· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 3·NCT03611751·1,020 enrolled

Study of Subcutaneous Risankizumab Injection Compared to Oral Apremilast Tablets to Assess Change in Disease Activity And Adverse Events in Adult Participants With Moderate Plaque Psoriasis Who Are Candidates for Systemic Therapy

Completed· AbbVie logo

AbbVie·Phase 4·NCT04908475·352 enrolled

To Check Comparison of Apremilast and Methotrexate Efficacy in Patients With Moderate to Severe Plaque Psoriasis Presented to Tertiary Care Hospital

Recruiting·SSyeda Sana Zaman·Phase 1·NCT07337434·106 enrolled

Study to Evaluate Safety and Effectiveness of Oral Apremilast (CC-10004) in Patients With Moderate to Severe Plaque Psoriasis.

Completed· Amgen logo

Amgen·Phase 3·NCT01232283·413 enrolled

A Long-term Extension Study of Apremilast (CC-10004) in Pediatric Subjects From 6 Through 17 Years of Age With Moderate to Severe Plaque Psoriasis

Completed· Amgen logo

Amgen·Phase 3·NCT04175613·160 enrolled

Apremilast as a Direct Treatment for Mild-to-moderate Plaque Psoriasis Versus Placebo: an Analysis of Clinical Safety and Efficacy

Completed· Amgen logo

Amgen·Phase 3·NCT03721172·595 enrolled

A Study to Assess Benefits of Apremilast in Patients With Moderate to Severe Chronic Plaque Psoriasis Followed by Dermatologists Under Real Life Settings in France

Completed· Amgen logo

Amgen··NCT03757013·453 enrolled

A Study to Describe the Characteristics of Patients Treated With Apremilast for Plaque Psoriasis in Italian Routine Clinical Practice

Completed· Amgen logo

Amgen··NCT04031027·184 enrolled

Apremilast Safety and PK Study in Recalcitrant Plaque Psoriasis

Completed· Amgen logo

Amgen·Phase 2·NCT00521339·31 enrolled

A Study About How Well TAK-279 Works and Its Safety in Participants With Moderate-to-severe Plaque Psoriasis During 52 Weeks of Treatment

Completed· Takeda logo

Takeda·Phase 3·NCT06088043·693 enrolled

Apremilast 30mg Bid With Narrowband UVB in the Treatment of Plaque Psoriasis

Completed·PPsoriasis Treatment Center of Central New Jersey·Phase 4·NCT02412644·29 enrolled

Apremilast in Palmo-Plantar Psoriasis

Completed·IInnovaderm Research Inc.·Phase 4·NCT02400749·100 enrolled

A Study Evaluating the Efficacy and Tolerability of Oral Apremilast for the Treatment of Nail Psoriasis

Completed·UUniversity of Alabama at Birmingham·Phase 4·NCT03022617·12 enrolled

Phase 3b Safety and Efficacy Study of Apremilast to Treat Moderate to Severe Plaque-plaque Psoriasis

Completed· Amgen logo

Amgen·Phase 3·NCT01690299·250 enrolled

Apremilast Treatment for Pruritus and Quality of Life in Scalp Psoriasis

Unknown status·UUniversity of Zurich·Phase 4·NCT03553433·90 enrolled

Efficacy and Safety Study of Apremilast (CC-10004) in Subjects With Moderate-to-Severe Plaque-Type Psoriasis (Core Study)

Completed· Amgen logo

Amgen·Phase 2·NCT00773734·352 enrolled

Efficacy and Safety of Apremilast in Psoriasis

Completed·GGhurki Trust and Teaching Hospital·Phase 4·NCT06032858·30 enrolled

Efficacy and Safety Study of Apremilast (CC-10004) in Pediatric Subjects From 6 Through 17 Years of Age With Moderate to Severe Plaque Psoriasis

Completed· Amgen logo

Amgen·Phase 3·NCT03701763·245 enrolled

CF101 Therapy in Patients With Moderate-to-severe Plaque Psoriasis

Completed·CCan-Fite BioPharma·Phase 3·NCT03168256·528 enrolled

Efficacy and Safety Study of Two Doses of Apremilast (CC-10004) In Japanese Patients With Moderate-To-Severe Plaque-Type Psoriasis

Completed· Amgen logo

Amgen·Phase 2·NCT01988103·254 enrolled

A Phase 4 Study of Efficacy and Safety of Apremilast in Subjects With Moderate Plaque Psoriasis.

Completed· Amgen logo

Amgen·Phase 4·NCT02425826·221 enrolled

A Study of the Impact of Apremilast (CC-10004) on Quality of Life, Efficacy, and Safety in Adults With Manifestations of Plaque Psoriasis and Impaired Quality of Life

Completed· Amgen logo

Amgen·Phase 4·NCT03774875·277 enrolled

Apremilast for Chronic Plaque Psoriasis (CPP) Patients Who Have Failed One Course of Biologic Therapy

Withdrawn·—·Phase 2·NCT01200264

An Efficacy and Safety Study of Apremilast (CC-10004) in Subjects With Moderate to Severe Genital Psoriasis

Completed· Amgen logo

Amgen·Phase 3·NCT03777436·289 enrolled

Real World Study on the Efficacy and Safety of Apremilast in Chinese Patients With Moderate to Severe Plaque Psoriasis, a Multi Center, Prospective, Observational Trial（REACT）

Completed·FFirst Hospital of China Medical University··NCT05863273·360 enrolled

Methotrexate Versus Apremilast for Pruritus in Psoriasis

Not yet recruiting·ZZarmeen Khawar·Phase 4·NCT07432386·80 enrolled

Effects of Treatment With Biological Agents on Vascular and Cardiac Function in Psoriasis

Unknown status·UUniversity of Athens·Phase 4·NCT02144857·200 enrolled

A Multicenter, Randomized, Double-blind, Double-dummy, Active Drug Parallel-controlled Phase III Clinical Trial Evaluating the Efficacy and Safety of Oral HPP737 in Adult Patients With Moderate to Severe Plaque Psoriasis.

Completed·NNewsoara Biopharma Co., Ltd.·Phase 3·NCT07712731·607 enrolled

Psoriatic Arthritis18 trials

Assessment of the Clinical and Ultrasound Response to Apremilast by Clinical Evaluation and by a Joint-periarticular-nail Ultrasound Index in Patients With Active Psoriatic Arthritis

Unknown status·HHospital Universitari Vall d'Hebron Research Institute·Phase 3·NCT03191539·56 enrolled

A Study to Evaluate the Use of Apremilast in Patients With Psoriatic Arthritis, Naïve to Biological Treatment

Completed· Amgen logo

Amgen··NCT03828045·119 enrolled

A Study of the Real-life Management of Psoriatic Arthritis Patients Treated With Otezla® (Apremilast) in Belgium

Completed· Amgen logo

Amgen··NCT03096990·106 enrolled

Show 15 more trials

A Study to Evaluate the Impact of Apremilast on Magnetic Resonance Imaging (MRI) Outcomes in Adults With Psoriatic Arthritis

Completed· Amgen logo

Amgen·Phase 4·NCT03783026·123 enrolled

Validation of the PsASon ULtrasound Scores in Patients With Psoriatic Arthritis Undergoing TReatment With Apremilast

Withdrawn·MMedical University of Graz·Phase 4·NCT04102449

Immune Metabolic Associations in Psoriatic Arthritis

Completed·NNHS Greater Glasgow and Clyde··NCT03399708·60 enrolled

A Study of Apremilast in Children With Oral Ulcers Associated With Behçet's Disease or Juvenile Psoriatic Arthritis

Recruiting· Amgen logo

Amgen·Phase 3·NCT05767047·48 enrolled

Phase II Study of Apremilast (CC-10004) in Adults With in Psoriatic Arthritis

Completed· Amgen logo

Amgen·Phase 2·NCT00456092·204 enrolled

Impact of Tapering Immunosuppressants on Maintaining Minimal Disease Activity in Adult Subjects With Psoriatic Arthritis

Unknown status·UUniversity of Erlangen-Nürnberg Medical School·Phase 3·NCT04610476·270 enrolled

Study to Evaluate the Real-World Effectiveness, Safety and Tolerability of Treatment With Apremilast in Psoriatic Arthritis Patients Followed in Canadian Routine Care (APPRAISE)

Completed· Amgen logo

Amgen··NCT03608657·102 enrolled

Efficacy and Safety Study of Apremilast to Treat Active Psoriatic Arthritis

Completed· Amgen logo

Amgen·Phase 3·NCT01172938·504 enrolled

PALACE 3: Efficacy and Safety Study of Apremilast to Treat Active Psoriatic Arthritis

Completed· Amgen logo

Amgen·Phase 3·NCT01212770·505 enrolled

PALACE 2: Efficacy and Safety Study of Apremilast to Treat Active Psoriatic Arthritis

Completed· Amgen logo

Amgen·Phase 3·NCT01212757·488 enrolled

Efficacy and Safety Study of Apremilast to Treat Active Psoriatic Arthritis (PsA)

Completed· Amgen logo

Amgen·Phase 3·NCT01307423·529 enrolled

Danish Population-based Assessment of Psoriasis and Psoriatic Arthritis (DANPAPP)

Unknown status·PProfessor Mikkel Østergaard·Phase 4·NCT04515732·115 enrolled

Safety and Efficacy Study of Apremilast to Treat Psoriatic Arthritis

Completed· Amgen logo

Amgen·Phase 3·NCT01925768·219 enrolled

A Multi-center, Randomized, Double-blind, Placebo-controlled Phase 3 Study to Evaluate the Efficacy and Safety of Deucravacitinib in Participants With Active Psoriatic Arthritis (PsA) Who Are Naïve to Biologic Disease Modifying Anti-rheumatic Drugs or Had Previously Received TNFα Inhibitor Treatment

Active, not recruiting· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 3·NCT04908189·729 enrolled

Comparative Study Between Apremilast and Adalimumab in Psoriatic Arthritis Patients

Not yet recruiting·TTanta University·Preclinical·NCT07398651·60 enrolled

Adult4 trials

Study to Evaluate the Pharmacokinetics of Single and Multiple Doses of Apremilast in Healthy Adult Male Korean Subjects

Completed· Amgen logo

Amgen·Phase 1·NCT02802735·28 enrolled

Bioequivalence Study of Two Products of Apremilast 30 mg Tablets in Healthy, Adult, Human Subjects

Completed·HHumanis Saglık Anonim Sirketi·Phase 3·NCT06084663·36 enrolled

Effects of Age and Sex on the Pharmacokinetics of Apremilast in Healthy Adults

Completed· Amgen logo

Amgen·Phase 1·NCT01634191·36 enrolled

Show 1 more trial

Effect of Food on the Pharmacokinetics of Apremilast (CC-10004) in Healthy Adults

Completed· Amgen logo

Amgen·Phase 1·NCT01634178·46 enrolled

Plaque Psoriasis4 trials

A Phase 3, Multi-center, Open-label, Single-arm Study to Assess the Safety of Apremilast (AMG 407) in Pediatric Participants From 6 Through 17 Years of Age With Mild to Moderate Plaque Psoriasis

Completed· Amgen logo

Amgen·Phase 3·NCT06088199·51 enrolled

A Multicenter, Randomized, Double-Blind, Placebo and Active Comparator Controlled Phase 3 Study in Patients With Moderate to Severe Plaque Psoriasis to Evaluate the Efficacy and Safety of ESK-001 (ONWARD2)

Completed·AAlumis Inc·Phase 3·NCT06588738·862 enrolled

A Multicenter, Randomized, Double-Blind, Placebo and Active Comparator Controlled Phase 3 Study to Evaluate the Efficacy and Safety of ESK-001 in Patients With Moderate to Severe Plaque Psoriasis (ONWARD1)

Completed·AAlumis Inc·Phase 3·NCT06586112·912 enrolled

Show 1 more trial

A Phase 3, Multicenter, Open-label, Single-arm Study to Assess the Efficacy and Safety of Apremilast (AMG 407) in Japanese Pediatric Subjects From 6 Through 17 Years of Age With Moderate to Severe Plaque Psoriasis

Active, not recruiting· Amgen logo

Amgen·Phase 3·NCT05565560·17 enrolled

Efficacy and Safety3 trials

Preliminary Efficacy and Safety of Apremilast in the Treatment of Acne Conglobata

Completed·—·Phase 2·NCT04161456·1 enrolled

A Phase 3 Randomized, Double-blind Study to Evaluate the Efficacy and Safety of Apremilast (CC-10004) in Subjects With Active Behçet's Disease

Completed· Amgen logo

Amgen·Phase 3·NCT02307513·207 enrolled

A Study to Evaluate the Efficacy and Safety of Apremilast (CC-10004) in the Treatment of Behçet Disease

Completed· Amgen logo

Amgen·Phase 2·NCT00866359·111 enrolled

43 more indications

Atopic Dermatitis3 trials

Efficacy and Safety Study of Apremilast in Subjects With Moderate to Severe Atopic Dermatitis

Completed· Amgen logo

Amgen·Phase 2·NCT02087943·191 enrolled

Utilization of a Microdevice for Psoriasis and Atopic Dermatitis

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

Apremilast for Atopic Dermatitis - A Pilot Study in Adults

Completed·OOregon Health and Science University·Phase 2·NCT01393158·16 enrolled

Palmoplantar Pustulosis3 trials

Apremilast in Patients With Moderate to Severe Palmoplantar Pustulosis (PPP) (APLANTUS)

Completed·KKristian Reich·Phase 2·NCT04572997·21 enrolled

A Study to Evaluate the Efficacy and Safety of Apremilast (CC-10004) in Japanese Subjects With Palmoplantar Pustulosis

Completed· Amgen logo

Amgen·Phase 2·NCT04057937·90 enrolled

Phase 3, Randomized Study of Apremilast in Japanese Participants With Palmoplantar Pustulosis (PPP)

Completed· Amgen logo

Amgen·Phase 3·NCT05174065·176 enrolled

Alcohol Use Disorder3 trials

Human Laboratory Study of Apremilast for Alcohol Use Disorder

Not yet recruiting·NNational Institute on Alcohol Abuse and Alcoholism (NIAAA)·Phase 2·NCT07325266·100 enrolled

Dose-response Study of Apremilast in Women and Men With Alcohol Use Disorder

Not yet recruiting·YYale University·Phase 2·NCT07029529·120 enrolled

Apremilast for Alcohol Use Disorder Treatment in Women and Men

Active, not recruiting·YYale University·Phase 1·NCT06324435·10 enrolled

Rheumatoid Arthritis2 trials

The Controlled Trial of Apremilast for Rheumatoid Arthritis Treatment (CARAT)

Completed·—·Phase 2·NCT01250548·34 enrolled

Study of Apremilast to Evaluate the Safety and Effectiveness for Patients With Rheumatoid Arthritis

Terminated· Amgen logo

Amgen·Phase 2·NCT01285310·237 enrolled

COVID-192 trials

I-SPY COVID-19 TRIAL: An Adaptive Platform Trial for Critically Ill Patients

Active, not recruiting·QQuantumLeap Healthcare Collaborative·Phase 2·NCT04488081·1,500 enrolled

Study of Multiple Candidate Agents for the Treatment of COVID-19 in Hospitalized Patients

Completed· Amgen logo

Amgen·Phase 3·NCT04590586·515 enrolled

AIN2 trials

Use of Apremilast in Patients Who Are Dissatisfied With Stable Maintenance Topical Therapy

Completed·DDerm Research, PLLC·Phase 4·NCT03000309·20 enrolled

The Maintenance Effect of Enstilar Foam in Combination With Otezla

Unknown status·DDerm Research, PLLC·Phase 4·NCT04555707·30 enrolled

Hidradenitis Suppurativa2 trials

Single Center Study of Apremilast for the Treatment of Hidradenitis Suppurativa

Completed·FFlorida Academic Dermatology Centers·Phase 2·NCT02695212·20 enrolled

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

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

Vitiligo2 trials

Combined Therapy With Narrow-Band Ultraviolet B Phototherapy and Apremilast for the Treatment of Vitiligo

Completed·IIcahn School of Medicine at Mount Sinai·Phase 2·NCT03123016·23 enrolled

Repigmentation Using Apremilast and Phototherapy In Diffuse VITILIGO

Completed·—·Phase 2·NCT03036995·80 enrolled

Lichen Planus2 trials

The AP-GELP Study: A Clinical Trial on the Effects of Apremilast in Female Genital Erosive Lichen Planus

Unknown status·OOslo University Hospital·Phase 2·NCT03656666·42 enrolled

Pilot Study of Apremilast (CC-10004) in the Treatment of Moderate to Severe Lichen Planus

Unknown status·VVirginia Clinical Research, Inc.·Phase 2·NCT01041625·10 enrolled

Oral Lichen Planus2 trials

Apremilast - Oral Lichen Planus Trial

Withdrawn·SSunnybrook Health Sciences Centre·Phase 2·NCT03836885

Efficacy and Safety of add-on Apremilast Versus add-on Methotrexate in Patients With Oral Lichen Planus

Completed·—·Phase 4·NCT06260904·64 enrolled

Alopecia Areata2 trials

Efficacy of Oral Apremilast in the Treatment of Alopecia Areata at the Tertiary Care Hospital, Karachi.

Completed·JJinnah Postgraduate Medical Centre·Phase 4·NCT05926882·30 enrolled

Pilot Study of the Safety and Efficacy of Apremilast in Subjects With Moderate to Severe Alopecia Areata

Completed·IIcahn School of Medicine at Mount Sinai·N/A·NCT02684123·30 enrolled

Dermatomyositis2 trials

Evaluating Safety & Efficacy of Apremilast in the Treatment of Cutaneous Disease in Patients With Recalcitrant Dermatomyositis

Completed·TTulane University·Phase 2·NCT03529955·8 enrolled

A Study to Evaluate the Safety and Efficacy of Apremilast in the Treatment of Skin Disease in Patients With Dermatomyositis

Terminated·SStanford University·N/A·NCT01140503·5 enrolled

Recurrent aphthous stomatitis1 trial

Randomized Double Blind Controlled Trial Comparing the Safety and Efficacy of Apremilast Versus Placebo in Severe Forms of Recurrent Aphthous Stomatitis

Recruiting·UUniversity Hospital, Rouen·Phase 3·NCT04227314·134 enrolled

Erythema Multiforme1 trial

Apremilast for Erythema Multiforme

Completed·RRobert Micheletti·Phase 2·NCT05875714·8 enrolled

Pregnancy1 trial

Apremilast Pregnancy Exposure Registry

Active, not recruiting·UUniversity of California, San Diego··NCT02775500·233 enrolled

Alopecia1 trial

Trial Evaluating the Efficacy of Apremilast for the Treatment of Frontal Fibrosing Alopecia

Unknown status·BBellevue Dermatology·Phase 4·NCT03422640·20 enrolled

Interaction1 trial

A Drug-Drug Interaction Study to Evaluate the Effect of Rifampin on the Pharmacokinetics of Apremilast

Completed· Amgen logo

Amgen·Phase 1·NCT01561963·21 enrolled

Methotrexate1 trial

Concomitant Use of Apremilast for the Treatment of Active RA Despite TNF-Inhibition and Methotrexate- CATARA

Withdrawn·SStanford University·Phase 2·NCT01204138

Pneumonia1 trial

Randomized, Embedded, Multifactorial Adaptive Platform Trial for Community- Acquired Pneumonia

Recruiting·UUMC Utrecht·Phase 3·NCT02735707·20,000 enrolled

ART1 trial

A Study of LY2775240 in Healthy Participants

Completed· Eli Lilly logo

Eli Lilly·Phase 1·NCT02963779·35 enrolled

Arthritis1 trial

Apremilast Therapy for Acute Gouty Arthritis

Withdrawn·—·Phase 2·NCT00997581

Alcoholism1 trial

Medication Development in Alcoholism: Apremilast Versus Placebo

Completed·TThe Scripps Research Institute·Phase 2·NCT03175549·51 enrolled

Spondylitis1 trial

Spondylitis Trial of Apremilast for Better Rheumatic Therapy

Completed·IImperial College London·Phase 2·NCT00944658·38 enrolled

Treatment1 trial

Apremilast in the Treatment of Moderate to Severe Acne

Terminated·UUniversity of North Carolina, Chapel Hill·Phase 2·NCT01074502·3 enrolled

Uveitis1 trial

Apremilast in the Treatment of Uveitis

Terminated·OOregon Health and Science University·Phase 1/2·NCT00889421·3 enrolled

Ulcerative Colitis1 trial

Efficacy and Safety Study of Apremilast to Treat Active Ulcerative Colitis

Completed· Amgen logo

Amgen·Phase 2·NCT02289417·170 enrolled

Contact Dermatitis1 trial

Study of Apremilast in Atopic or Contact Dermatitis

Completed·TTufts Medical Center·Phase 2·NCT00931242·10 enrolled

Nummular Eczema1 trial

An Investigator-initiated Study of Apremilast to Demonstrate Efficacy Nummular Eczema

Completed·TTechnical University of Munich·Phase 2·NCT03160248·31 enrolled

Ankylosing Spondylitis1 trial

Study of Apremilast to Treat Subjects With Active Ankylosing Spondylitis

Completed· Amgen logo

Amgen·Phase 3·NCT01583374·490 enrolled

Dermatitis1 trial

Apremilast and Moderate to Severe Chronic Hand Dermatitis

Withdrawn·GGeorge Washington University·Phase 4·NCT03741933

Prurigo Nodularis1 trial

Apremilast as Anti-pruritic Treatment in Patients With Prurigo Nodularis

Unknown status·TTanja Todberg, MD·Phase 1/2·NCT03576287·15 enrolled

Oral1 trial

Study to Evaluate Bioavailability of Apremilast Oral Suspension Relative to Tablet and to Assess Effect of Food on the Pharmacokinetics (PK) of the Oral Suspension

Completed· Amgen logo

Amgen·Phase 1·NCT02641353·34 enrolled

Tics1 trial

Study to Evaluate Pharmacokinetics of Prototype Modified-Release Formulations Of Apremilast in Healthy Men

Completed· Amgen logo

Amgen·Phase 1·NCT02236988·80 enrolled

Medication1 trial

A Study Examining the Medication Apremilast as Treatment for Chronic Itch

Completed·WWashington University School of Medicine·Phase 2·NCT03239106·10 enrolled

Cicatricial Alopecia1 trial

Apremilast in the Treatment of Central Centrifugal Cicatricial Alopecia (CCCA)

Completed·IIcahn School of Medicine at Mount Sinai·Phase 4·NCT03521687·20 enrolled

Osteoarthritis1 trial

Efficacy Study of Apremilast (CC-10004) in Subjects With Erosive Hand Osteoarthritis

Completed·UUniversity of Erlangen-Nürnberg Medical School·Phase 2·NCT01200472·30 enrolled

Efficacy1 trial

Short-term Safety, Efficacy and Mode of Action of Apremilast in Moderate Suppurative Hidradenitis

Completed·MM.B.A. van Doorn·Phase 2·NCT03049267·20 enrolled

Rosacea1 trial

Open Label Pilot Study of Apremilast in Treatment of Rosacea

Completed·JJulian M. Mackay-Wiggan·Phase 2·NCT01045551·10 enrolled

Arthritis, Psoriatic1 trial

A Phase 4, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Apremilast (CC-10004) in Subjects With Early, Oligoarticular Psoriatic Arthritis Despite Initial Stable Treatment With Either NSAIDS and/or ≤ 1 Conventional Synthetic DMARD

Completed· Amgen logo

Amgen·Approved·NCT03747939·310 enrolled

Juvenile Psoriatic Arthritis1 trial

A Phase 3, Multicenter, Double-blind, Randomized, Placebo-controlled, Parallel Group Study to Evaluate the Efficacy, Safety and Pharmacokinetics of Apremilast in Children From 5 to Less Than 18 Years of Age With Active Juvenile Psoriatic Arthritis (PEAPOD)

Recruiting· Amgen logo

Amgen·Phase 3·NCT04804553·60 enrolled

Depression1 trial

[18F]PF-06445974 to Image PDE4B in Major Depressive Disorder Using PET

Recruiting·NNational Institute of Mental Health (NIMH)·Phase 1·NCT05703685·108 enrolled

Behçet Disease1 trial

A Phase 3, Multicenter, Double-blind, Randomized, Placebo-controlled, Parallel Group Study, Followed by an Active Treatment Phase to Evaluate the Efficacy and Safety of Apremilast in Children From 2 to Less Than 18 Years of Age With Active Oral Ulcers Associated With Behçet's Disease (BEAN)

Recruiting· Amgen logo

Amgen·Phase 3·NCT04528082·60 enrolled

Unspecified2 trials

Apremilast 30 mg Twice Daily (BID) Combined With Dupilumab

Completed·TTufts Medical Center·Phase 2·NCT04306965·10 enrolled

Apremilast for RAS

Completed·MMayo Clinic·Phase 4·NCT03690544·15 enrolled

Regulatory

FDA Approval Timeline[5]

Mar 21, 2014

OTEZLA

NDA NDA205437

Aug 29, 2025

OTEZLA XR

NDA NDA210745

Sources

References

[1]
ClinicalTrials.gov — 129 trial records for Apremilast. U.S. National Library of Medicine, National Institutes of Health.
[2]
MedlinePlus Drug Information — Otezla drug information. U.S. National Library of Medicine, National Institutes of Health.
[3]
ChEMBL — Apremilast compound record. European Bioinformatics Institute (EMBL-EBI).
[4]
Open Targets Platform — Drug–disease associations for Apremilast. EMBL-EBI & Wellcome Sanger Institute.
[5]
OpenFDA — FDA approval records (NDA NDA210745). U.S. Food & Drug Administration.
[6]
FDA Orange Book — Patent and exclusivity data for Otezla. U.S. Food & Drug Administration.
[7]
SEC EDGAR — Amgen company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: Phosphodiesterase 4 Inhibitor[3]
Modality: Small molecule[3]
Highest Phase: Approved[1]
Company: Amgen

Patent Landscape[6]

Patent Cliff

Feb 16, 2028

Earliest patent expiration — generic entry possible after this date

Patent #Expires

7427638Feb 16, 2028

7427638*PEDAug 16, 2028

12576034Nov 30, 2033

10092541May 29, 2034

9872854May 29, 2034

6 more patents

12576034*PEDMay 30, 2034

9872854*PEDNov 29, 2034

10092541*PEDNov 29, 2034

11969409May 27, 2042

12427136May 27, 2042

11752129May 27, 2042

Otezla

Status by Indication[4][1]

Competitive Landscape

Expected Milestones

Q4 2026

Q3 2027

Q4 2027

Q1 2028

Trials by Indication[1]

Psoriasis41 trials

Psoriatic Arthritis18 trials

Adult4 trials

Plaque Psoriasis4 trials

Efficacy and Safety3 trials

Atopic Dermatitis3 trials

Palmoplantar Pustulosis3 trials

Alcohol Use Disorder3 trials

Rheumatoid Arthritis2 trials

COVID-192 trials

AIN2 trials

Hidradenitis Suppurativa2 trials

Vitiligo2 trials

Lichen Planus2 trials

Oral Lichen Planus2 trials

Alopecia Areata2 trials

Dermatomyositis2 trials

Recurrent aphthous stomatitis1 trial

Erythema Multiforme1 trial

Pregnancy1 trial

Alopecia1 trial

Interaction1 trial

Methotrexate1 trial

Pneumonia1 trial

ART1 trial

Arthritis1 trial

Alcoholism1 trial

Spondylitis1 trial

Treatment1 trial

Uveitis1 trial

Ulcerative Colitis1 trial

Contact Dermatitis1 trial

Nummular Eczema1 trial

Ankylosing Spondylitis1 trial

Dermatitis1 trial

Prurigo Nodularis1 trial

Oral1 trial

Tics1 trial

Medication1 trial

Cicatricial Alopecia1 trial

Osteoarthritis1 trial

Efficacy1 trial

Rosacea1 trial

Arthritis, Psoriatic1 trial

Juvenile Psoriatic Arthritis1 trial

Depression1 trial

Behçet Disease1 trial

Unspecified2 trials

FDA Approval Timeline[5]

References

Drug Info

Quick Facts

Patent Landscape[6]

Related News