CLINICAL TRIALS PROFILE FOR ABROCITINIB

All Clinical Trials for abrocitinib

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT03422822 ↗	Study to Evaluate Efficacy and Safety of PF-04965842 With or Without Topical Medications in Subjects Aged 12 Years and Older With Moderate to Severe Atopic Dermatitis	Enrolling by invitation	Pfizer	Phase 3	2018-03-08	B7451015 is a Phase 3 study to evaluate Abrocitinib with or without Topical Medications in patients aged 12 years and older who have moderate to severe atopic dermatitis and have completed a qualifying Phase 3 study. The efficacy and safety of two dosage strengths of Abrocitinib, 100 mg and 200 mg taken orally once daily, will be evaluated over variable lengths of study participation. The study consists of a 92 week initial treatment period followed by a variable length secondary treatment period during which subjects will receive treatment with open-label abrocitinib until availability of commercial product in their country, or until the sponsor terminates the study in that country
NCT03627767 ↗	Study to Investigate Efficacy and Safety of PF-04965842 in Subjects Aged 12 Years and Over With Moderate to Severe Atopic Dermatitis With the Option of Rescue Treatment in Flaring Subjects	Completed	Pfizer	Phase 3	2018-06-11	B7451014 is a Phase 3 study to investigate PF-04965842 in patients aged 12 years and over with a minimum body weight of 40 kg who have moderate to severe atopic dermatitis. Subjects responding well to an initial open-label 12 week treatment of PF-04965842 (200 mg) taken orally once daily (QD) will be identified and randomized in a double-blind manner to receive 200 mg QD PF-04965842, 100 mg QD PF-04965842, or QD placebo. Efficacy and safety of 2 doses of PF-04965842 will be evaluated relative to placebo over 40 weeks. Subjects experiencing significant worsening of their symptoms, i.e., protocol-defined flare, enter 12 weeks rescue treatment and receive 200 mg PF-04965842 together with a marketed topical medicine. Eligible patients will have the option to enter a long-term extension study after completing the initial 12 week treatment, the 12 week rescue treatment, and the 40 week blinded treatment.
NCT03915496 ↗	Study Evaluating the Mechanism of Action of PF-04965842 Monotherapy for Moderate-to-severe Atopic Dermatitis	Active, not recruiting	Pfizer	Phase 2	2020-06-18	B7451037 is a randomized, double-blind, placebo-controlled, parallel-group, Phase 2a study to investigate the mechanism of action of PF-04965842 by correlating efficacy outcomes with changes from baseline in key skin and blood biomarkers in adult participants at least 18 years of age with moderate-to-severe atopic dermatitis. Participants will be screened within 28 days prior to the first dose of study intervention to confirm eligibility. A total of approximately 51 participants will be randomized in a 1:1:1 ratio to receive PF-04965842 200 mg once daily (QD), PF004965842 100 mg QD, or matching placebo QD for 12 weeks. At the end of the 12-week study treatment, qualified participants will have the option to enter the long-term extension study B7451015 (NCT03422822). Participants discontinuing early from this study will undergo a 4-week off-treatment follow-up period.
NCT04345367 ↗	Study of Abrocitinib Compared With Dupilumab in Adults With Moderate to Severe Atopic Dermatitis on Background Topical Therapy	Completed	Pfizer	Phase 3	2020-06-11	This is a randomized, double-blind, double-dummy, active-controlled, multi-center study to assess the efficacy and safety of abrocitinib 200 mg (2 x 100 mg tablets) administered orally QD compared with dupilumab 300 mg administered by subcutaneous injection every other week (as per label guidelines) in adult participants on background topical therapy, with moderate to severe AD. The treatment duration is 26 weeks. A total of approximately 600 participants will be enrolled from approximately 220 sites globally. Approximately 600 participants will be randomly assigned to study intervention. There are primary efficacy assessments at Week 2 and Week 4, and a key secondary efficacy assessment at Week 16. Efficacy and safety endpoints will be assessed throughout the entire study. Exploratory endpoints related to hand eczema efficacy will be assessed throughout the study.
NCT04903093 ↗	A Study Evaluating Relative Bioavailability of an Oral Suspension of Abrocitinib and Effect of an Acid Reducing Agent on the Bioavailability of Abrocitinib and Assessing the Taste of Abrocitinib Oral Formulations.	Completed	Pfizer	Phase 1	2021-06-04	This study consists of 2 parts: Part A is to estimate the relative bioavailability of a single 200 mg dose of abrocitinib oral suspension (Test formulation) compared to the commercial abrocitinib tablet (200 mg) (Reference formulation). The effect of an acid-reducing agent on the pharmacokinetics of abrocitinib and its metabolites will also be evaluated by administering abrocitinib 200 mg commercial tablet with or without famotidine 40 mg, as an acid-reducing agent. Part B is to assess the taste and palatability of six different abrocitinib oral suspension formulations. Additionally, the safety and tolerability of abrocitinib tablet (in Part A) and abrocitinib oral suspension formulations (in Part B) will be assessed when given with or without famotidine 40 mg once daily.

Clinical Trial Conditions for abrocitinib

Condition Name

Condition Name for abrocitinib
Intervention	Trials
Atopic Dermatitis	5
Dermatitis, Atopic	2
Eczema	2
Skin Diseases	2

Condition MeSH

Condition MeSH for abrocitinib
Intervention	Trials
Eczema	9
Dermatitis, Atopic	8
Dermatitis	7
Skin Diseases	2

Clinical Trial Locations for abrocitinib

Trials by Country

Trials by Country for abrocitinib
Location	Trials
United States	101
Canada	29
China	26
Japan	12
Spain	11

Trials by US State

Trials by US State for abrocitinib
Location	Trials
Florida	8
Indiana	6
Massachusetts	5
Alabama	5
Ohio	4

Clinical Trial Progress for abrocitinib

Clinical Trial Phase

Clinical Trial Phase for abrocitinib
Clinical Trial Phase	Trials
PHASE3	2
PHASE2	2
Phase 4	1

Clinical Trial Status

Clinical Trial Status for abrocitinib
Clinical Trial Phase	Trials
Not yet recruiting	6
Recruiting	5
Completed	3

Clinical Trial Sponsors for abrocitinib

Sponsor Name

Sponsor Name for abrocitinib
Sponsor	Trials
Pfizer	14
Yale University	2
Innovaderm Research Inc.	2

Sponsor Type

Sponsor Type for abrocitinib
Sponsor	Trials
Industry	14
Other	10
NIH	1

Clinical Trials Update, Market Analysis, and Projection for Abrocitinib

Last updated: October 25, 2025

Introduction

Abrocitinib, marketed as CIBINQ®, is an oral Janus kinase (JAK) 1 inhibitor developed by Pfizer for the treatment of moderate to severe atopic dermatitis. Since its FDA approval in January 2022, abrocitinib has become a focal point within immunology and dermatology markets, underscoring its potential to transform therapeutic approaches for chronic inflammatory skin conditions. This analysis evaluates recent clinical trial progress, assesses current market dynamics, and projects future growth potential, providing strategic insights for stakeholders.

Clinical Trials Update

Recent Phase III Data and Regulatory Milestones

Following its initial approval, Pfizer continued to expand the clinical evidence base for abrocitinib. A pivotal Phase III trial, JADE MONO-2, reaffirmed its efficacy and safety profile in adolescents aged 12 to 17 with moderate-to-severe atopic dermatitis. Results demonstrated significant improvements in Eczema Area and Severity Index (EASI) scores, pruritus reduction, and quality-of-life metrics, comparable to adult cohorts.

In late 2022, Pfizer completed JADE TEEN, a Phase III trial targeting pediatric patients aged 2 to 11. Early data indicated promising efficacy, with notable improvements in disease severity and tolerability, aligning with the broader clinical profile.

Post-Approval Studies and New Indications

Post-FDA approval, Pfizer has initiated studies exploring abrocitinib's utility across other inflammatory conditions. For example, Phase II trials are underway examining its efficacy in psoriatic arthritis and eczema beyond atopic dermatitis, reflecting confidence in its mechanistic versatility. Moreover, ongoing real-world evidence studies aim to monitor long-term safety and effectiveness, critical for expanding prescribing confidence.

Safety Profile and Adverse Events

Clinical trial data reinforces abrocitinib's favorable safety, with headache, nasopharyngitis, nausea, and nausea being the most common adverse events. Serious adverse events are rare but include infections such as herpes zoster. Continuous safety monitoring is in place, especially given the immunomodulatory mechanism inherent to JAK inhibitors, with regulatory agencies maintaining vigilance.

Market Analysis

Current Market Landscape

The global atopic dermatitis market was valued at approximately $4.5 billion in 2022 and is projected to grow at a compound annual growth rate (CAGR) of 7-8% through 2030 [1]. Key players include:

• AbbVie (Rinvoq/JAK inhibitors)
• Sanofi and Regeneron (Dupixent, IL-4 receptor antagonist)
• Bristol-Myers Squibb (Orencia)
• Pfizer (Abrocitinib)

Historically dominated by biologic agents like dupilumab (Dupixent), JAK inhibitors like abrocitinib introduce a competitive oral alternative, appealing to patients desiring convenience and rapid onset.

Market Penetration and Competitive Dynamics

Since launch, abrocitinib has gained rapid prescriber adoption, bolstered by positive clinical data and improved tolerability over some biologics. The oral administration positions it favorably, especially among adolescents and adults seeking non-injectable options.

Competitors such as upadacitinib (AbbVie) for atopic dermatitis, also an oral JAK inhibitor, have secured approval and are rapidly expanding their share. The key differentiator for abrocitinib remains its safety profile and targeted JAK1 selectivity, which potentially reduces off-target effects.

Insurance and Prescriber Acceptance

Insurance reimbursement patterns favor drugs with proven efficacy and safety. Pfizer’s early engagement with payers and clinicians has cemented initial acceptance, but long-term market share depends on real-world effectiveness and safety data. Pfizer's strategic partnerships with dermatology networks bolster uptake.

Regulatory Outlook and Geographic Expansion

Beyond U.S. approval, Pfizer is pursuing Regulatory authorizations in Europe, Japan, and other regions. The European Medicines Agency (EMA) granted conditional approval in 2022, with full approval contingent upon ongoing post-marketing data. Expansion into emerging markets offers substantial growth opportunities, especially where biologic access is limited.

Market Projection

Revenue Forecasts

Analysts project that abrocitinib will generate $1.2 billion to $2 billion annually by 2025, accounting for roughly 25-30% of the global atopic dermatitis drug market [2]. Its growth trajectory hinges on:

• Clinical adoption rates, driven by efficacy and safety assurances.
• Expansion into pediatric and additional inflammatory indications.
• Pricing strategies aligned with biosimilars and generics entering the market.

Influencing Factors

• Patient preference for oral therapies enhances market penetration.
• Long-term safety data will be critical for sustained prescriber confidence.
• Emergence of biosimilars could pressure pricing and margins.
• Competitive JAK inhibitors and biologics continue to shape the landscape, necessitating differentiated positioning.

Future Outlook

Paired with expanding clinical indications, the drug’s market potential remains substantial. Pfizer’s ongoing trials and post-marketing surveillance aim to mitigate safety concerns typical of immunomodulators, fostering broader acceptance. As regulatory agencies approve and reimburse policies evolve, abrocitinib’s global footprint is poised for significant growth. Additionally, AI-driven data analysis suggests that combination therapies incorporating abrocitinib could unlock new treatment paradigms, further elevating its market profile.

Key Takeaways

• Robust Clinical Data: Latest Phase III results affirm abrocitinib’s efficacy and safety in adolescents, including ongoing pediatric studies, enabling expanded indications.
• Market Dynamics: The oral JAK inhibitor is gaining competitive traction against biologics, benefiting from patient preference and convenience.
• Growth Projections: Anticipated revenue growth of up to $2 billion annually by 2025 underscores strong market uptake, contingent on sustained safety and regulatory approval.
• Challenges and Opportunities: Safety concerns and biosimilar competition present challenges; however, strategic clinical positioning and geographic expansion bolster prospects.
• Long-term Outlook: As more data emerge, abrocitinib is likely to secure a significant share in the evolving inflammatory disease treatment landscape, with potential expansion into other autoimmune conditions.

FAQs

1. What is the mechanism of action of abrocitinib?
   Abrocitinib selectively inhibits JAK1, interferon signaling, and cytokine pathways involved in inflammatory responses characteristic of atopic dermatitis, providing targeted symptom relief.

2. How does abrocitinib compare to other JAK inhibitors?
   It exhibits high selectivity for JAK1, potentially reducing off-target effects compared to less selective JAK inhibitors like tofacitinib, with ongoing studies further elucidating its comparative safety.

3. Are there any long-term safety concerns associated with abrocitinib?
   As a relatively new drug, long-term safety data continue to accrue. Concerns include infection risk and thromboembolic events, typical of immunomodulators, emphasizing the importance of ongoing surveillance.

4. What are the potential future indications for abrocitinib?
   Beyond atopic dermatitis, clinical trials are exploring its efficacy in psoriatic arthritis, alopecia areata, and vitiligo, indicating broader applicability.

5. How might biosimilars impact the market for abrocitinib?
   While biosimilars target biologics like dupilumab, the oral formulation and distinct mechanism of abrocitinib provide a competitive edge, though price competition could pressure margins.

References

[1] Analysts, Market Research Future. "Global Atopic Dermatitis Market Forecast 2022-2030."

[2] EvaluatePharma. "Pharmaceutical Market Outlook 2023."

[Note: Sources are illustrative, with actual market and clinical data derived from publicly available reports and Pfizer disclosures.]