TheraRadar
Data updated: May 26, 2026

OTEZLA XR (apremilast)

Phosphodiesterase 4 Inhibitors Trial Activity: Declining 14 active trials
Immunology Approved 2025-08-29

OTEZLA XR is indicated for the treatment of Psoriatic Arthritis; Plaque Psoriasis; Behcet's Disease.

Source: FDA Label • Amgen • Phosphodiesterase 4 Inhibitor
Jump to: Indications Approvals Trials Competitors Similar Safety Patents

How OTEZLA XR Works

Apremilast is an oral small molecule inhibitor of phosphodiesterase 4 (PDE4) that is specific for cyclic adenosine monophosphate (cAMP). By inhibiting the PDE4 enzyme, the drug increases the levels of cAMP within cells. While the specific biological mechanisms by which these increased levels produce a therapeutic effect are not well defined, the drug's primary action is the targeted inhibition of PDE4.

Source: FDA Label

Development Insights

Amgen conducting 31 trials (39%)
52 indications explored (Broad Platform)
→ psoriasis (16 trials)
→ plaque psoriasis (13 trials)
→ psoriatic arthritis (6 trials)
1
Indication
--
Phase 3 Trials
0
Years on Market

Details

Status
Prescription
First Approved
2025-08-29
Patent Cliff
2042

Pro Metrics

Patent cliff and revenue data

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Routes
ORAL
Dosage Forms
TABLET, EXTENDED RELEASE

Companies

Amgen
Active Ingredient: APREMILAST

OTEZLA XR Approval History

2026
Original
New Indication
New Form
Label Update
2 FDA actions from 2025 to 2025
Aug 2025 ORIGINAL
Update · Type 5 - New Formulation or New Manufacturer
FDA Letter Label

What OTEZLA XR Treats

3 indications

OTEZLA XR is approved for 3 conditions since its original approval in 2025. These indications span multiple therapeutic areas including oncology, immunology, and more.

  • Psoriatic Arthritis
  • Plaque Psoriasis
  • Behcet's Disease
Source: FDA Label

OTEZLA XR Competitive Set

Pro

Three rings of competition based on shared molecular targets and treated indications.

MoA expansion candidates

2

Same target(s), different indications — where else is this mechanism being explored?

ROFLUMILAST
PRINSTON INC
2018 2 indic.
DALIRESP
AstraZeneca
2011 2 indic.

Indication competitors

10

Same indication, different mechanism — what else might this patient receive?

STARJEMZA
BIO-THERA SOLUTIONS
2025 4 indic.
YESINTEK
BIOCON BIOLOGICS
2024 4 indic.
Unlock 8 more competitors across all three rings.
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Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.

What's emerging in OTEZLA XR's indications

See all emerging drugs →

Phase 3 candidates targeting molecules with no FDA-approved drug, in indications OTEZLA XR treats. First-in-class if their pivotal trials read out positive.

Tulisokibart MK-7240 / PRA023
Merck Sharp & Dohme LLC
TNFSF15 · monoclonal antibody (anti-TL1A) · 3 Phase 3 trials

Drugs Similar to OTEZLA XR

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BIMEKIZUMAB-BKZX
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UCB INC
Shared indications:
Plaque PsoriasisPsoriatic Arthritis
CIMZIA
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Shared indications:
Psoriatic ArthritisPlaque Psoriasis
CYLTEZO
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Shared indications:
Psoriatic ArthritisPlaque Psoriasis
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Clinical Trial Registry

78 trials
Trial Sponsor ID Phase Status Title
NCT07325266 HLAB-004 Ph 2 recruiting Human Laboratory Study of Apremilast for Alcohol Use Disorder
NCT05703685 10000676 000676-M Ph 1 recruiting [18F]PF-06445974 to Image PDE4B in Major Depressive Disorder Using PET
NCT04804553 PEAPOD 20190529 Ph 3 recruiting Apremilast Pediatric Study in Children With Active Juvenile Psoriatic Arthritis
NCT06586112 ONWARD1 ESK-001-016 Ph 3 completed A Study to Evaluate the Efficacy and Safety of ESK-001 in Patients With Moderate to Severe Plaque Psoriasis
NCT06588738 ONWARD2 ESK-001-017 Ph 3 completed A Study in Patients With Moderate to Severe Plaque Psoriasis to Evaluate the Efficacy and Safety of ESK-001
NCT03036995 Rapid Vitiligo 16-PP-06 Ph 2 completed Repigmentation Using Apremilast and Phototherapy In Diffuse VITILIGO
NCT04488081 I-SPY_COVID I-SPY-COVID Ph 2 active not recruiting I-SPY COVID-19 TRIAL: An Adaptive Platform Trial for Critically Ill Patients
NCT07432386 PEMH-DERM-RCT-2026-01 Ph 4 not yet recruiting Methotrexate Versus Apremilast for Pruritus in Psoriasis
NCT04227314 PREMS 2019/0411/HP Ph 3 recruiting Randomized Double Blind Controlled Trial Comparing the Safety and Efficacy of Apremilast Versus Placebo in Severe Forms of Recurrent Aphthous Stomatitis
NCT06324435 2000037439 1U54AA027989-01 Ph 1 active not recruiting Apremilast for Alcohol Use Disorder Treatment in Women and Men
NCT07352566 25-43621 Ph 4 not yet recruiting Utilization of a Microdevice for Psoriasis and Atopic Dermatitis
NCT06122649 ESSENCE 20200250 Ph 3 completed 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)
NCT04175613 CC-10004-PPSO-004 U1111-1242-3537, 2019-003497-13 Ph 3 completed 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
NCT05565560 20200346 Ph 3 active not recruiting A Study to Assess the Efficacy and Safety of Apremilast in Japanese Pediatric Participants With Moderate to Severe Plaque Psoriasis
NCT06260904 AIIMS BBSR/PGThesis/23-24/112 Ph 4 completed Efficacy and Safety of add-on Apremilast Versus add-on Methotrexate in Patients With Oral Lichen Planus
NCT05767047 20190531 2022-003024-41, 2023-503433-21 Ph 3 recruiting A Study of Apremilast in Children With Oral Ulcers Associated With Behçet's Disease or Juvenile Psoriatic Arthritis
NCT04528082 BEAN 20190530 2023-503436-40-00 Ph 3 recruiting Apremilast Pediatric Study in Children With Active Oral Ulcers Associated With Behçet's Disease
NCT06108544 TAK-279-3002 2023-505842-24-00 Ph 3 completed 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
NCT06088199 20200196 Ph 3 active not recruiting A Study of Apremilast in Pediatric Participants in Children With Mild to Moderate Plaque Psoriasis
NCT06088043 TAK-279-3001 jRCT2031230583, 2023-505841-22-00 Ph 3 completed A Study About How Well TAK-279 Works and Its Safety in Participants With Moderate-to-severe Plaque Psoriasis During 52 Weeks of Treatment
NCT05875714 AEM 842831 Ph 2 completed Apremilast for Erythema Multiforme
NCT03774875 EMBRACE results posted CC-10004-PSOR-020 U1111-1224-8381, 2018-002850-58 Ph 4 completed 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
NCT04908189 results posted IM011-055 2020-005099-36, U1111-1259-9466 Ph 3 active not recruiting A Study to Determine the Efficacy and Safety of Deucravacitinib Compared With Placebo in Participants With Active Psoriatic Arthritis (PsA) Who Are Naïve to Biologic Disease Modifying Anti-rheumatic Drugs or Had Previously Received TNFα Inhibitor Treatment
NCT05174065 results posted 20200195 Ph 3 completed Phase 3, Randomized Study of Apremilast in Japanese Participants With Palmoplantar Pustulosis (PPP)
NCT03783026 MOSAIC results posted CC-10004-PSA-014 U1111-1223-9823, 2018-002748-10 Ph 4 completed A Study to Evaluate the Impact of Apremilast on Magnetic Resonance Imaging (MRI) Outcomes in Adults With Psoriatic Arthritis
NCT04057937 results posted CC-10004-PPP-001 U1111-1236-1239 Ph 2 completed A Study to Evaluate the Efficacy and Safety of Apremilast (CC-10004) in Japanese Subjects With Palmoplantar Pustulosis
NCT02735707 REMAP-CAP U1111-1189-1653 2015-002340-14, 602525 Ph 3 recruiting Randomized, Embedded, Multifactorial Adaptive Platform Trial for Community- Acquired Pneumonia
NCT03022617 results posted IRB-160720004 Ph 4 completed A Study Evaluating the Efficacy and Tolerability of Oral Apremilast for the Treatment of Nail Psoriasis
NCT03721172 ADVANCE results posted CC-10004-PSOR-022 U1111-1218-8372 Ph 3 completed Apremilast as a Direct Treatment for Mild-to-moderate Plaque Psoriasis Versus Placebo: an Analysis of Clinical Safety and Efficacy
NCT03777436 DISCREET results posted CC-10004-PSOR-025 U1111-1224-6850, 2018-002608-15 Ph 3 completed An Efficacy and Safety Study of Apremilast (CC-10004) in Subjects With Moderate to Severe Genital Psoriasis
NCT04908475 results posted M20-326 2020-005512-21 Ph 4 completed 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
NCT04306965 results posted 13305 Ph 2 completed Apremilast 30 mg Twice Daily (BID) Combined With Dupilumab
NCT02425826 UNVEIL results posted CC-10004-PSOR-012 Ph 4 completed A Phase 4 Study of Efficacy and Safety of Apremilast in Subjects With Moderate Plaque Psoriasis.
NCT03624127 POETYK-PSO-1 results posted IM011-046 2018-001926-25 Ph 3 completed Effectiveness and Safety of BMS-986165 Compared to Placebo and Active Comparator in Participants With Psoriasis
NCT03442088 results posted 07-17-33 Ph 2 completed Monocyte Biomarkers in Moderate to Severe Plaque Psoriasis Subjects Treated With Apremilast
NCT03611751 POETYK-PSO-2 results posted IM011-047 2018-001925-24 Ph 3 completed 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
NCT03082729 VIP-A results posted 826652 97509210 Ph 4 completed Vascular Inflammation in Psoriasis - Apremilast
NCT03175549 results posted U01AA025476 Ph 2 completed Medication Development in Alcoholism: Apremilast Versus Placebo
NCT04590586 COMMUNITY results posted COV-01 Ph 3 completed Study of Multiple Candidate Agents for the Treatment of COVID-19 in Hospitalized Patients
NCT03521687 results posted GCO 17-2386 Ph 4 completed Apremilast in the Treatment of Central Centrifugal Cicatricial Alopecia (CCCA)
NCT01194219 ESTEEM 1 results posted CC-10004-PSOR-008 Ph 3 completed Study to Evaluate Safety and Effectiveness of Oral Apremilast (CC-10004) in Patients With Moderate to Severe Plaque Psoriasis
NCT01232283 ESTEEM 2 results posted CC-10004-PSOR-009 Ph 3 completed Study to Evaluate Safety and Effectiveness of Oral Apremilast (CC-10004) in Patients With Moderate to Severe Plaque Psoriasis.
NCT01690299 results posted CC-10004-PSOR-010 2012-000859-14 Ph 3 completed Phase 3b Safety and Efficacy Study of Apremilast to Treat Moderate to Severe Plaque-plaque Psoriasis
NCT04161456 APACCO TMP-0517 Ph 2 completed Preliminary Efficacy and Safety of Apremilast in the Treatment of Acne Conglobata
NCT03930186 results posted CC-10004-PSOR-023 U1111-1230-7468, 20200062 Ph 3 completed 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
NCT03160248 APREMINUM AP-CL-ECZ-PI-006539 Ph 2 completed An Investigator-initiated Study of Apremilast to Demonstrate Efficacy Nummular Eczema
NCT04572997 APLANTUS results posted 069-008. 2016-005122-11 Ph 2 completed Apremilast in Patients With Moderate to Severe Palmoplantar Pustulosis (PPP) (APLANTUS)
NCT02307513 results posted CC-10004-BCT-002 2014-002108-25 Ph 3 completed A Phase 3 Randomized, Double-blind Study to Evaluate the Efficacy and Safety of Apremilast (CC-10004) in Subjects With Active Behçet's Disease
NCT03239106 results posted CIP-ApremilastCC-10004 Ph 2 completed A Study Examining the Medication Apremilast as Treatment for Chronic Itch
NCT02802735 results posted CC-10004-CP-033 Ph 1 completed Study to Evaluate the Pharmacokinetics of Single and Multiple Doses of Apremilast in Healthy Adult Male Korean Subjects

Showing 50 of 78 trials

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Trial Timeline

ClinicalTrials.gov ↗ Pro

Full development history with FDA approval milestones

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Understanding FDA Approval Types
Count Type What it means
- ORIG Original approval - drug first enters market
- SUPPL - Efficacy New indication (new disease/condition approved)
- SUPPL - Labeling Label text changes (warnings, dosing updates)
- SUPPL - Manufacturing Production changes (new facility)
- SUPPL - Chemistry Formulation changes (new dosage strength)

Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.

OTEZLA XR FDA Label Details

Indications & Usage

FDA Label (PDF)

OTEZLA XR is indicated for the treatment of Psoriatic Arthritis; Plaque Psoriasis; Behcet's Disease.

View full patent landscape →
5 OB patents · 3 families · 152 international docs across 28 countries

OTEZLA XR Patents & Exclusivity

Latest Patent: May 2042
Exclusivity: Jan 2027

Patents (5 active)

US11752129 Expires May 27, 2042
US12427136 Expires May 27, 2042
US11969409 Expires May 27, 2042
US10092541 Expires May 29, 2034
US7427638 Expires Feb 16, 2028

Exclusivity

M-299 Until Jul 2026
ODE* Until Jul 2026
PED Until Jan 2027
PED Until Jan 2027
Source: FDA Orange Book

Pro Intelligence Preview

Deep insights for OTEZLA XR

Revenue Insights

  • • Quarterly revenue tracking
  • • Historical trend analysis

Patent Timeline

  • • Cliff: 2042
  • • 9 active patents

Trial Analysis

  • • 80 total trials
  • • Stage: Declining

Competitive Landscape

  • • 20 similar drugs
  • • Same target/indication analysis
Unlock Full Intelligence

Full approval history • All patents • Revenue trends • Competitor analysis

Data Sources

FDA Approval: NDA210745 → Label: DailyMed → Patents: FDA Orange Book → Trials: ClinicalTrials.gov →

Data sourced from official FDA and NIH databases. Click links to verify on original sources.

How We Calculate These Metrics

Trial Activity Stage

Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.

Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.

  • Growth: High proportion of early-phase trials (Phase 1/2), active development
  • Expansion: Significant Phase 3 activity, approaching or pursuing approvals
  • Mature: Substantial Phase 4 post-marketing studies
  • Stable: Mixed phase distribution, steady development
  • Declining: Low active trial ratio, reduced R&D investment