RegulationPriority Review (United States), Breakthrough Therapy (United States), Priority Review (China), Promising Innovative Medicine (United Kingdom)

Structure/Sequence

Molecular FormulaC14H21N5O2S

InChIKeyIUEWXNHSKRWHDY-PHIMTYICSA-N

CAS Registry1622902-68-4

Clinical Trials associated with Abrocitinib

NCT07448363

/ Not yet recruitingNot ApplicableIIT

National Registry of Patients With Atopic Dermatitis Under Treatment With Dupilumab and JAK Inhibitors Within the Costa Rican Social Security System

The goal of this observational registry is to characterize the clinical features, severity, treatments, and outcomes of patients with atopic dermatitis in Costa Rica receiving systemic and advanced therapies in routine clinical practice. The main questions it aims to answer are:
What are the demographic and clinical characteristics of patients with moderate-to-severe atopic dermatitis treated in specialized dermatology centers in Costa Rica?
What treatments are used in real-world practice and how do they impact disease severity and patient-reported outcomes over time?
Participants with atopic dermatitis receiving systemic or advanced therapies as part of their usual medical care will be followed longitudinally, with collection of clinical severity scores, treatment patterns, and outcomes during routine visits.

Start Date01 May 2026

Sponsor / Collaborator-

NCT06899204

/ RecruitingNot Applicable

A Prospective, Multi-center Observational Study Characterizing Clinical Outcomes of Patients Receiving Abrocitinib for Moderate-to-severe Atopic Dermatitis Who Had an Inadequate Response (or Intolerance) to ≤2 Previous Biologic Therapies Approved for Moderate-to-severe Atopic Dermatitis

This is a prospective, multi-center observational study characterizing clinical and patient reported outcomes of patients receiving abrocitinib for moderate-to-severe atopic dermatitis (M2S AD) who had inadequate response (or intolerance) to ≤2 previous biologic therapies approved for M2S AD in the United States.
The aim of this study is to measure the effectiveness of abrocitinib in a real-world setting in patients with moderate-to-severe atopic dermatitis, with inadequate response or intolerance to ≤2 biologic therapies.

Start Date13 Jan 2026

Sponsor / Collaborator

Pfizer Inc.

NCT07242638

/ RecruitingPhase 2IIT

Use of Specific JAK Inhibition on Inflammatory Skin and Scalp Diseases in Down Syndrome R61AR084210

This is a single-center, open-label, basket phase 2b trial that will enroll Down Syndrome (DS) participants with at least one inflammatory skin condition (Atopic Dermatitis (AD) and/or Alopecia Areata (AA)). Patients will receive Abrocitinib 100 mg daily for 12 weeks. Responders (defined as achieving Eczema Area and Severity Index (EASI) 75 response for AD, or SALT <= 20 for AA) will be kept on this dose, and non-responders based on these definitions, will initiate 200 mg daily for another 12 weeks. All AD and AA patients will be maintained on the respective dose of Abrocitinib from Week 24 through week 60.

Start Date12 Jan 2026

Sponsor / Collaborator

Icahn School of Medicine at Mount Sinai

100 Clinical Results associated with Abrocitinib

100 Translational Medicine associated with Abrocitinib

100 Patents (Medical) associated with Abrocitinib

531

Literatures (Medical) associated with Abrocitinib

31 Dec 2026·JOURNAL OF DERMATOLOGICAL TREATMENT

Dose-dependent effectiveness and patient-reported outcomes with JAK1 inhibitors in atopic dermatitis: a 36-week multicenter real-world cohort

Article

Author: Ulutaş Demirbaş, Gözde ; Esen, Mustafa ; Diremsizoglu, Esin ; Demirbaş, Abdullah

BACKGROUND:

Dose-stratified real-world data for JAK1 inhibitors in AD are limited.

OBJECTIVE:

To compare effectiveness and safety of standard vs high doses of abrocitinib and upadacitinib in routine care.

METHODS:

Multicenter, retrospective cohort study. The primary endpoint was Week-12 achievement of Eczema Area and Severity Index (EASI)-75. Secondary outcomes included patient-reported improvements at Minimal Clinically Important Difference (MCID) thresholds, Minimal Disease Activity (MDA) at Week 36, time-to-EASI-75, and treatment-emergent adverse events(TEAE).

RESULTS:

A total of 124 patients were analyzed (abrocitinib 100 mg, n = 28; abrocitinib 200 mg, n = 32; upadacitinib 15 mg, n = 30; upadacitinib 30 mg, n = 34). At Week 12, EASI-75 was achieved in 20/32 (62.5%) versus 10/28 (35.7%) for abrocitinib (OR 2.94, 95% CI 1.06-8.15; p = 0.036) and in 22/34 (64.7%) versus 14/30 (46.7%) for upadacitinib (OR 2.92, 95% CI 1.16-7.38; p = 0.021), favoring the higher-dose regimens. Itch improvement was more frequent with higher doses. By Week 36, full minimal disease activity was observed in 30.2% of patients receiving abrocitinib 200 mg and 26.7% receiving upadacitinib 30 mg, compared with 18.4% and 20.0% in the lower-dose groups. Kaplan-Meier analysis showed faster responses with high doses (median 12 vs 36 weeks; log-rank p < 0.01). Safety was comparable across groups.

CONCLUSION:

High-dose JAK1 regimens achieve faster, numerically greater disease control without short-term safety tradeoffs, supporting escalation in suboptimal responders.

31 Dec 2026·JOURNAL OF MEDICAL ECONOMICS

Cost-utility and budget impact analysis of dupilumab and oral Janus kinase (JAK) inhibitors for treating moderate-to-severe atopic dermatitis in Taiwan

Article

Author: Lee, John Tayu ; Wu, David Bin-Chia ; Shen, Toby Kai-Bo ; Yang, Rachel Ai-Ting ; Tan, Hsiao-Hsiao ; Liu, Valerie Tzu-Ning ; Wang, Yen Hsiang

BACKGOROUND:

Atopic dermatitis (AD), a chronic inflammatory skin disease, affects 1.28% of Taiwan's population, with 26.69% having moderate-to-severe cases, causing significant healthcare costs and quality-of-life impairments. Conventional treatments often fail these patients, necessitating novel therapies like dupilumab and Janus kinase (JAK) inhibitors (abrocitinib, baricitinib, upadacitinib). This study evaluates the cost-utility and budget impact of these therapies versus best supportive care (BSC) for adults with moderate-to-severe AD from Taiwan's NHI perspective.

METHODS:

A hybrid decision tree-Markov model assessed short- and long-term (Years 1-20) outcomes using trial efficacy, NHI costs (2022 NT$), and EQ-5D utilities. Interventions included topical corticosteroids/calcineurin inhibitors. Outcomes were quality-adjusted life-years (QALYs) and incremental cost-effectiveness ratios (ICERs), discounted at 3%, with a NT$2,000,000/QALY threshold. Sensitivity analyses tested robustness. A five-year (2026-2030) budget impact analysis (BIA) included epidemiology and market uptake.

RESULTS:

Upadacitinib 30 mg was most cost-effective (11.0782 QALYs, ICER NT$1,250,903/QALY vs BSC), followed by Upadacitinib 15 mg (NT$1,376,435/QALY). Dupilumab was dominated; Baricitinib's ICERs exceeded NT$2,000,000/QALY. Sensitivity analyses confirmed robustness, with utility gains, medication costs, and discontinuation rates as key drivers. The BIA estimated a NT$117 billion incremental impact, driven by drug costs, with per-patient increments falling from NT$339,769 to NT$264,728.

CONCLUSION:

Upadacitinib 30 mg was the most cost-effective option for moderate-to-severe atopic dermatitis in Taiwan, but its high budget impact underscores the need for strategic pricing and reimbursement policies to ensure long-term affordability and access.

02 Mar 2026·Dermatitis

Decision-Making Factors for Systemic Therapies in Atopic Dermatitis: A Clinical Review.

Review

Author: Mehta, Apoorva ; Guttman-Yassky, Emma ; O'Hagan, Ross ; Lamb, Angela J ; Levine, Jasmine

Atopic dermatitis (AD) is a chronic, relapsing inflammatory skin disease that significantly impairs quality of life. In recent years, treatment has advanced from broad immunosuppressants to targeted biologics and small-molecule therapies that modulate type 2 inflammation and itch signaling. Dupilumab, tralokinumab, lebrikizumab, and nemolizumab are now FDA-approved biologics with demonstrated efficacy and favorable long-term safety, while oral Janus kinase inhibitors (JAKis) such as abrocitinib, upadacitinib, and baricitinib often provide rapid disease control but carry black-box warnings. Comparative trials highlight faster itch relief with JAKis but durable disease control and safety advantages with biologics. The expanding treatment landscape necessitates individualized therapy selection. Key clinical considerations include patient age, pregnancy status, infection, malignancy, or thromboembolic risk, comorbid conditions, and history of adverse effects. Equally important are patient-centered preferences such as dosing frequency, route of administration, storage logistics, and willingness to self-inject. Access and affordability also influence care, with many manufacturers offering copay support and patient assistance programs. Future directions emphasize head-to-head comparative studies, biomarker development for precision treatment, and equitable access to advanced therapies. This narrative review synthesizes current evidence on biologics and JAKis in AD, outlining efficacy, safety, and practical decision-making factors to guide dermatologists in aligning therapies with both clinical context and patient priorities.

News (Medical) associated with Abrocitinib

08 Apr 2026
·www.biospace.com

/C O R R E C T I O N -- American Academy of Dermatology/

In the news release, American Academy of Dermatology Issues First-Ever Pediatric Atopic Dermatitis Guidelines, Highlighting Prevention Strategies and Effective Treatments, issued 07-Apr-2026 by American Academy of Dermatology over PR Newswire, we are advised by the company that the 5th bullet in the list was modified to read "ruxolitinib cream" and a 6th bullet was added for "Topical aryl hydrocarbon receptor (AhR) agonists". The complete, corrected release follows: American Academy of Dermatology Issues First-Ever Pediatric Atopic Dermatitis Guidelines, Highlighting Prevention Strategies and Effective Treatments New evidence-based guidelines establish insufficient evidence or no benefit to dietary or environmental interventions ROSEMONT, Ill. , April 8, 2026 /PRNewswire/ -- For the first time in its history, the American Academy of Dermatology (AAD) has published guidelines of care for both the prevention and management of atopic dermatitis (commonly known as eczema) in pediatric patients. While pediatric and adult eczema share similarities, these guidelines recognize the unique safety, dosing, and patient-caregiver-clinician interactions of individuals under the age of 18. The most common pediatric skin disease, eczema affects up to 25% of children worldwide. It is a long-lasting inflammatory skin disease often marked by itchy skin, dry patches, rashes, and rough bumps. "Eczema is extremely common in children, though it doesn't always look or behave the same way it does in adults," said AAD President and board-certified dermatologist Murad Alam, MD, FAAD . "Because eczema can decrease the quality of life of children and their families, we need dedicated guidelines just for children to ensure their best care." The new guidelines, published in the Journal of the American Academy of Dermatology (JAAD) , will guide dermatologists in deciding the best possible prevention and treatment options for pediatric patients. The guidelines were developed by a working group of 14 experts, including 11 board-certified dermatologists and one pediatric allergist. Prevention Because eczema is so common and can significantly affect a child's health, there is strong interest in identifying ways to help prevent it. However, current research shows that supplemental therapies like special diets or skipping baths aren't proven to prevent eczema. Moisturizers were the only treatment to receive a conditional recommendation for use to reduce the occurrence of eczema in children aged 6 months to 3 years. Conditional recommendations reflect an intervention whose benefits are closely balanced with risks and burdens. These recommendations apply to most patients, but the most appropriate action may differ depending on the patient and presentation. The guidelines find insufficient evidence or no benefit to dietary or environmental interventions, including early food introduction, human milk consumption, probiotic or vitamin D supplementation, water softening, and dust mite avoidance. Treatment There are more treatments for eczema than ever before, though standard treatments like regular moisturizing remain effective in managing eczema in children. The guidelines provide 26 evidence-based recommendations for topical therapies (prescription and non-prescription), phototherapy, and systemic therapies based on the treatment's reduction of eczema symptoms and itch severity, inclusive of the below. Strong recommendations reflect treatments in which benefits clearly outweigh the risks and burdens. These recommendations apply to most children with eczema in most circumstances. Strong recommendations were made for the use of the following: Moisturizers to reduce the severity of patients' dry, itchy skin. Topical calcineurin inhibitors (pimecrolimus 1% cream and tacrolimus 0.03% or 0.1% ointment) to manage patients' flares when their dry, itchy skin worsens and as intermittent maintenance therapy. Topical corticosteroids (steroid creams), considered a first-line treatment in most cases due to affordability and accessibility, to manage patients' flares and as maintenance therapy. Phosphodiesterate-4 inhibitors (crisaborole ointment and roflumilast cream) to reduce patients' itchiness and decrease the frequency of flares. When used proactively, roflumilast can keep skin clearer more consistently. Topical JAK inhibitors (ruxolitinib cream) to decrease the severity of the dry, itchy skin in patients with mild to moderate eczema. Topical aryl hydrocarbon receptor (AhR) agonists (tapinarof cream) to reduce inflammation, improve skin barrier function, and decrease the severity of dry, itchy skin in patients with mild, moderate and severe eczema. Monoclonal antibodies (dupilumab, tralokinumab, and lebrikizumab) to decrease the severity of eczema symptoms, reduce flares and improve itching in patients with moderate to severe eczema. JAK inhibitors (upadacitinib, abrocitinib, and baricitnib) to decrease the severity of eczema symptoms and improve itching in patients with moderate to severe eczema. Conditional recommendations were made for the use of treatments inclusive of the following: Bathing for treatment and maintenance for pediatric patients, followed by a moisturizer as standard care. Wet wrap therapy , under the guidance of a healthcare professional skilled in eczema management, are typically encouraged for patients during eczema flares. Phototherapy (light therapy) at a dermatologist's office can be used to treat patients with severe cases of eczema involving many body sites. Strong recommendations were made against systemic corticosteroids, which should be reserved exclusively for patients with sudden, severe flares and as short-term bridge therapy. Conditional recommendations were made against the use of topical antimicrobials and PUVA phototherapy for children with eczema. "These guidelines were developed to educate and empower patients, caregivers, and the medical community so children with eczema receive the best care possible. Early, proactive intervention allows improvement in symptoms and quality of life for patients and their families," said board-certified dermatologist Dawn Davis, MD, FAAD , co-chair of the AAD's Atopic Dermatitis Guideline Workgroup. "Since 2014, the landscape for eczema care has been transformed by the approval of new therapies for adults. Our goal was to review how these advancements relate to the pediatric population so children also receive optimal, individualized care." "Many children's eczema cases can be improved with a treatment plan made specially just for their needs, and starting treatment early can help keep the problem from getting worse," said Dr. Alam. "Please partner with a board-certified dermatologist to get expert care for your child's eczema." To find a board-certified dermatologist in your area, visit aad.org/findaderm. Resources Childhood Eczema About the AAD Headquartered in Rosemont, Ill., the American Academy of Dermatology, founded in 1938, is the largest, most influential and most representative of all dermatologic associations. With a membership of more than 21,800 physicians worldwide, the AAD is committed to advancing the diagnosis and medical, surgical, and cosmetic treatment of the skin, hair, and nails; advocating high standards in clinical practice, education and research in dermatology; and supporting and enhancing patient care because skin, hair, and nail conditions can have a serious impact on your health and well-being. For more information, contact the AAD at (888) 462-DERM (3376) or aad.org . Follow @AADskin on Facebook , TikTok , Pinterest , and YouTube , and @AADskin1 on Instagram . View original content to download multimedia: SOURCE American Academy of Dermatology

07 Apr 2026
·www.prnewswire.com

American Academy of Dermatology Issues First-Ever Pediatric Atopic Dermatitis Guidelines, Highlighting Prevention Strategies and Effective Treatments

New evidence-based guidelines establish insufficient evidence or no benefit to dietary or environmental interventions ROSEMONT, Ill., April 7, 2026 /PRNewswire/ -- For the first time in its history, the American Academy of Dermatology (AAD) has published guidelines of care for both the prevention and management of atopic dermatitis (commonly known as eczema) in pediatric patients. While pediatric and adult eczema share similarities, these guidelines recognize the unique safety, dosing, and patient-caregiver-clinician interactions of individuals under the age of 18. The most common pediatric skin disease, eczema affects up to 25% of children worldwide. It is a long-lasting inflammatory skin disease often marked by itchy skin, dry patches, rashes, and rough bumps. "Eczema is extremely common in children, though it doesn't always look or behave the same way it does in adults," said AAD President and board-certified dermatologist Murad Alam, MD, FAAD. "Because eczema can decrease the quality of life of children and their families, we need dedicated guidelines just for children to ensure their best care." The new guidelines, published in the Journal of the American Academy of Dermatology (JAAD), will guide dermatologists in deciding the best possible prevention and treatment options for pediatric patients. The guidelines were developed by a working group of 14 experts, including 11 board-certified dermatologists and one pediatric allergist. Prevention Because eczema is so common and can significantly affect a child's health, there is strong interest in identifying ways to help prevent it. However, current research shows that supplemental therapies like special diets or skipping baths aren't proven to prevent eczema. Moisturizers were the only treatment to receive a conditional recommendation for use to reduce the occurrence of eczema in children aged 6 months to 3 years. Conditional recommendations reflect an intervention whose benefits are closely balanced with risks and burdens. These recommendations apply to most patients, but the most appropriate action may differ depending on the patient and presentation. The guidelines find insufficient evidence or no benefit to dietary or environmental interventions, including early food introduction, human milk consumption, probiotic or vitamin D supplementation, water softening, and dust mite avoidance. Treatment There are more treatments for eczema than ever before, though standard treatments like regular moisturizing remain effective in managing eczema in children. The guidelines provide 26 evidence-based recommendations for topical therapies (prescription and non-prescription), phototherapy, and systemic therapies based on the treatment's reduction of eczema symptoms and itch severity, inclusive of the below. Strong recommendations reflect treatments in which benefits clearly outweigh the risks and burdens. These recommendations apply to most children with eczema in most circumstances. Strong recommendations were made for the use of the following: Moisturizers to reduce the severity of patients' dry, itchy skin. Topical calcineurin inhibitors (pimecrolimus 1% cream and tacrolimus 0.03% or 0.1% ointment) to manage patients' flares when their dry, itchy skin worsens and as intermittent maintenance therapy. Topical corticosteroids (steroid creams), considered a first-line treatment in most cases due to affordability and accessibility, to manage patients' flares and as maintenance therapy. Phosphodiesterate-4 inhibitors (crisaborole ointment and roflumilast cream) to reduce patients' itchiness and decrease the frequency of flares. When used proactively, roflumilast can keep skin clearer more consistently. Topical JAK inhibitors (ruxolitinib cream and tapinarof cream) to decrease the severity of the dry, itchy skin in patients with mild to moderate eczema. Monoclonal antibodies (dupilumab, tralokinumab, and lebrikizumab) to decrease the severity of eczema symptoms, reduce flares and improve itching in patients with moderate to severe eczema. JAK inhibitors (upadacitinib, abrocitinib, and baricitnib) to decrease the severity of eczema symptoms and improve itching in patients with moderate to severe eczema. Conditional recommendations were made for the use of treatments inclusive of the following: Bathing for treatment and maintenance for pediatric patients, followed by a moisturizer as standard care. Wet wrap therapy, under the guidance of a healthcare professional skilled in eczema management, are typically encouraged for patients during eczema flares. Phototherapy (light therapy) at a dermatologist's office can be used to treat patients with severe cases of eczema involving many body sites. Strong recommendations were made against systemic corticosteroids, which should be reserved exclusively for patients with sudden, severe flares and as short-term bridge therapy. Conditional recommendations were made against the use of topical antimicrobials and PUVA phototherapy for children with eczema. "These guidelines were developed to educate and empower patients, caregivers, and the medical community so children with eczema receive the best care possible. Early, proactive intervention allows improvement in symptoms and quality of life for patients and their families," said board-certified dermatologist Dawn Davis, MD, FAAD, co-chair of the AAD's Atopic Dermatitis Guideline Workgroup. "Since 2014, the landscape for eczema care has been transformed by the approval of new therapies for adults. Our goal was to review how these advancements relate to the pediatric population so children also receive optimal, individualized care." "Many children's eczema cases can be improved with a treatment plan made specially just for their needs, and starting treatment early can help keep the problem from getting worse," said Dr. Alam. "Please partner with a board-certified dermatologist to get expert care for your child's eczema." To find a board-certified dermatologist in your area, visit aad.org/findaderm. Resources Childhood Eczema About the AAD Headquartered in Rosemont, Ill., the American Academy of Dermatology, founded in 1938, is the largest, most influential and most representative of all dermatologic associations. With a membership of more than 21,800 physicians worldwide, the AAD is committed to advancing the diagnosis and medical, surgical, and cosmetic treatment of the skin, hair, and nails; advocating high standards in clinical practice, education and research in dermatology; and supporting and enhancing patient care because skin, hair, and nail conditions can have a serious impact on your health and well-being. For more information, contact the AAD at (888) 462-DERM (3376) or aad.org. Follow @AADskin on Facebook, TikTok, Pinterest, and YouTube, and @AADskin1 on Instagram. SOURCE American Academy of Dermatology 21% more press release views with Request a Demo

30 Mar 2026
·allsci.com

Sanofi’s amlitelimab meets Phase III endpoints in atopic dermatitis with extended 12-week dosing interval

Sanofi (NASDAQ: SNY) reported Phase III data from three trials of amlitelimab in moderate-to-severe atopic dermatitis, showing that the anti-OX40L antibody met primary endpoints across monotherapy and combination settings — with efficacy at a dosing interval of once every 12 weeks that matched the every-four-week regimen. The results, presented as late-breaking research at the 2026 American Academy of Dermatology annual meeting in Denver, position amlitelimab as a mechanistically distinct entrant into a treatment landscape that has grown crowded but remains defined by frequent dosing and incomplete responses. The COAST 1 and COAST 2 trials were randomized, double-blind, placebo-controlled Phase III studies evaluating amlitelimab monotherapy in adults and adolescents aged 12 and older with moderate-to-severe atopic dermatitis. SHORE used the same design but tested amlitelimab in combination with topical corticosteroids, with or without topical calcineurin inhibitors. Across the three trials, 1,786 patients were enrolled at sites spanning North America, Europe, Asia, and Latin America. The primary endpoint for all three studies was the proportion of patients achieving a validated Investigator Global Assessment for atopic dermatitis (vIGA-AD) score of 0 or 1 — clear or almost clear skin — with at least a two-point reduction from baseline at Week 24. Both the Q4W and Q12W amlitelimab arms met this endpoint in each trial.For US and US reference countries, the primary endpoint was vIGA-AD 0/1 with a ≥2-point reduction. Of note, for the EU reference countries and Japan, the studies used co-primary endpoints that included the same vIGA-AD measure plus EASI-75. In COAST 1, vIGA-AD 0/1 rates were 21.1% (Q4W) and 22.5% (Q12W) versus 9.2% for placebo. EASI-75 — the proportion of patients achieving at least 75% improvement in the Eczema Area and Severity Index — reached 35.9% and 39.1% in the Q4W and Q12W arms, respectively, compared to 19.1% for placebo. Itch reduction, measured by a four-point or greater decrease in peak pruritus numerical rating scale, was 22.5% (Q4W) and 24.5% (Q12W) versus 12.7% for placebo. All key secondary endpoints in COAST 1 reached statistical significance. COAST 2 showed a similar pattern, with vIGA-AD 0/1 rates of 25.3% (Q4W) and 25.7% (Q12W) versus 14.8% for placebo. EASI-75 and itch endpoints reached nominal significance, though one secondary endpoint — vIGA-AD 0/1 with barely perceptible erythema — did not achieve statistical significance. The distinction between the two monotherapy trials is worth noting: COAST 2’s higher placebo response rate narrowed the treatment delta, a common challenge in atopic dermatitis trials with geographically diverse enrollment. SHORE, the combination study, produced the highest absolute response rates. vIGA-AD 0/1 was achieved by 28.7% (Q4W) and 32.3% (Q12W) of patients versus 16.8% on placebo plus topical therapy alone. EASI-75 reached 48.1% and 46.8% in the active arms versus 32.3% for placebo. All primary and key secondary endpoints were statistically significant. Across all three trials, Sanofi reported that efficacy was progressively increasing at Week 24 with no evidence of plateau, suggesting that longer treatment durations may yield higher response rates — a pattern that will be tested in the ongoing ESTUARY extension study. The safety profile was consistent with earlier-phase data. The most common adverse events across COAST 1, COAST 2, and SHORE were nasopharyngitis, atopic dermatitis flares, and upper respiratory tract infections, occurring at rates generally comparable to or lower than placebo. Malignancy rates were below 1% and similar between active and placebo groups. No severe injection site reactions or serious gastrointestinal ulceration events were reported. Sanofi disclosed a second case of Kaposi’s sarcoma in the amlitelimab development program, identified in the still-blinded ESTUARY Phase III extension study. Both Kaposi’s sarcoma cases occurred in patients with known risk factors, and both patients discontinued treatment and entered recovery. Out of an estimated 3,778 patients exposed to amlitelimab across all indications, no additional cases have been identified. The signal remains numerically small but warrants monitoring given the immunomodulatory mechanism. Sanofi stated that it “believes that amlitelimab continues to have the potential to be a meaningful and convenient option for patients with AD”. Amlitelimab is a fully human, non-T cell depleting monoclonal antibody that blocks OX40 ligand, a costimulatory molecule involved in the activation and survival of effector T cells. By targeting this upstream pathway, the drug aims to modulate pathogenic immune responses without the broad immunosuppression associated with JAK inhibitors or the cytokine-specific blockade of IL-4/IL-13 antibodies. The non-depleting design distinguishes it from therapies that reduce T cell populations, potentially offering a different safety-efficacy tradeoff. The atopic dermatitis treatment landscape in 2026 includes six approved systemic therapies for moderate-to-severe disease: dupilumab and tralokinumab (both anti-IL-4/IL-13 pathway), lebrikizumab (anti-IL-13), nemolizumab (anti-IL-31 receptor), and the oral JAK1 inhibitors abrocitinib and upadacitinib. All approved injectable biologics require dosing every two to four weeks. Amlitelimab’s Q12W regimen — approximately four injections per year — would represent a substantial reduction in treatment burden if the dosing schedule is maintained in regulatory filings. Cross-trial comparisons are limited by differences in study populations, placebo rates, and endpoint definitions, but the absolute vIGA-AD 0/1 and EASI-75 rates observed in the COAST and SHORE trials are numerically lower than those reported for dupilumab and upadacitinib in their respective pivotal programs. Whether the dosing convenience and mechanistic novelty offset the apparent efficacy gap will be a central question for regulators, payers, and prescribers. Rocatinlimab, developed by Amgen, targets the OX40 receptor rather than the ligand and is also in Phase III development for atopic dermatitis. The two drugs represent competing approaches to the same pathway, and their relative clinical profiles will become clearer as more data emerge. A 2024 review in the Journal of Dermatology and Therapy examined both molecules, noting that while they share a pathway target, their binding sites and downstream effects may differ. Results from ESTUARY, evaluating Q12W maintenance dosing and longer-term safety, are anticipated in the second half of 2026. Your email address will not be published. Required fields are marked * Comment * Name * Email * Website

Clinical ResultPhase 3Immunotherapy

100 Deals associated with Abrocitinib

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KEGG	Wiki	ATC	Drug Bank
D11400	Abrocitinib	D11AH	DB14973

R&D Status

Approved

10 top approved records.
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Indication	Country/Location	Organization	Date
Dermatitis, Atopic	United Kingdom	Pfizer Inc.	08 Sep 2021

Developing

10 top R&D records.
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Indication	Highest Phase	Country/Location	Organization	Date
Eczema	Phase 3	United States	Pfizer Inc.	11 Jun 2018
Eczema	Phase 3	China	Pfizer Inc.	11 Jun 2018
Eczema	Phase 3	Argentina	Pfizer Inc.	11 Jun 2018
Eczema	Phase 3	Belgium	Pfizer Inc.	11 Jun 2018
Eczema	Phase 3	Brazil	Pfizer Inc.	11 Jun 2018
Eczema	Phase 3	Bulgaria	Pfizer Inc.	11 Jun 2018
Eczema	Phase 3	Canada	Pfizer Inc.	11 Jun 2018
Eczema	Phase 3	Chile	Pfizer Inc.	11 Jun 2018
Eczema	Phase 3	Germany	Pfizer Inc.	11 Jun 2018
Eczema	Phase 3	Israel	Pfizer Inc.	11 Jun 2018

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Clinical Result

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Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


AAD2026	Not Applicable	-	9	Abrocitinib	zqnseimuvb(ipgzutxovh) = one developed mild thrombocytopenia ipnayqntgi (mzoqkjhima )	Positive	27 Mar 2026
NCT03422822 (JADE EXTEND, AAD2026)	Phase 2/3	Dermatitis, Atopic	1,708	Abrocitinib 200 mg	fwflspfrdh(dvdmhblcsr) = nppaaxqzto ojxwgstipf (vwxnalqwan ) View more	Positive	27 Mar 2026
				Abrocitinib 100 mg	fwflspfrdh(dvdmhblcsr) = kghimncyzj ojxwgstipf (vwxnalqwan ) View more
AAD2026	Not Applicable	Severe Atopic Dermatitis	3,322	Abrocitinib (adolescents + biologic-naive)	rzvzafjvhs(lzbshcwbvj) = vxmhiwhvlu pdtgyczwcm (fylxpajzbx )	Positive	27 Mar 2026
				Abrocitinib (adolescents + biologic-exposed)	rzvzafjvhs(lzbshcwbvj) = ixybvnjilm pdtgyczwcm (fylxpajzbx )
AAD2026	Not Applicable	Alopecia Universalis	329	Tofacitinib	vdlpyhqgar(umxqtuxkkk) = Tofacitinib was associated with shingles, acneiform eruptions, infections, gastrointestinal symptoms, weight gain, and one case of multiple sclerosis. Ruxolitinib caused mild cytopenias and gastrointestinal issues; upadacitinib led to hair depigmentation; filgotinib caused acneiform eruptions. Safety data for ritlecitinib, abrocitinib, and deuruxolitinib were limited. ssngomsqrk (gecdmgdyzd )	Positive	27 Mar 2026
AAD2026	Not Applicable	Severe Atopic Dermatitis	68	Abrocitinib	bynhkizxjr(zyjyapltvc) = mbdpnlvfuh zcakkevzqu (terphcmkkx ) View more	Positive	27 Mar 2026
AAD2026	Phase 2/3	Dermatitis, Atopic	2,187	Abrocitinib 200 mg	skcinsnoqx(mxcryikukb) = dhfosmoglj htrhctxsls (vqtunhqlwt ) View more	Positive	27 Mar 2026
				Placebo	skcinsnoqx(mxcryikukb) = awdkkfbarq htrhctxsls (vqtunhqlwt ) View more
AAD2026	Not Applicable	Skin Diseases	103,275	Upadacitinib	nirmgcjwtd(dqogvwocyo) = median onset ranged from 103 to 358 days across drugs, with early-failure type pattern ( 31), indicating AE rates declined over time. Tofacitinib cumulative AE curve differed significantly from others (adj.p 3C2e-16). bqnqgaqqha (ijpmcxvrlo ) View more	Positive	27 Mar 2026
				Baricitinib
AAD2026	Not Applicable	Dermatitis, Atopic	31	Abrocitinib	jeniqhvwyn(arkzthldek) = dxvknivlqp jlivcniywc (bepkhqrxiv )	Positive	27 Mar 2026
NCT03627767 (JADE REGIMEN, AAD2026)	Phase 3	Moderate Atopic Dermatitis	392	Abrocitinib 200 mg	qtreuthzgf(exgzomcbpq) = ouhaqjcaiy nhbxouelnj (tooolnuruc ) View more	Positive	27 Mar 2026
				Abrocitinib 100 mg	qtreuthzgf(exgzomcbpq) = yiishlctue nhbxouelnj (tooolnuruc ) View more
NCT02780167 (MONO-1/2, AAD2026)	Phase 2/3	Dermatitis, Atopic	1,239	Abrocitinib 100 mg monotherapy	icgfgdncln(dogcaijqbh) = kyhqcpaqwb jhvofdjejd (yiutqifsmp ) View more	Positive	27 Mar 2026
				Abrocitinib 200 mg monotherapy	icgfgdncln(dogcaijqbh) = zzuaytlwox jhvofdjejd (yiutqifsmp ) View more

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Abrocitinib

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