Drugs / Abrocitinib
Regulatory milestones approvals, filings & regulatory actions · 6 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed atopic eczema 2 milestones | |||||
| Filed | EU (EMA) | — | atopic eczema | 2020-10-27 | “The European Medicines Agency (EMA) has also accepted the Marketing Authorization Application (MAA) for abrocitinib” pfizer.com ↗ |
| Filed | US (FDA) | — | atopic eczema | 2020-10-27 | “the U.S. Food and Drug Administration (FDA) accepted for filing and granted Priority Review designation to the company’s New Drug Application (NDA) for abrocitinib” pfizer.com ↗ |
| Approved Indication not stated 3 milestones | |||||
| Label expansions (2) | US (FDA) | CIBINQO | — | 2023-02-09 – 2023-12-14 | fda.gov ↗ |
| Approved | US (FDA) | CIBINQO | — | 2022-01-14 | fda.gov ↗ |
| Approved | EU (EMA) | Cibinqo | — | 2021-12-09 | europa.eu ↗ |
Trials 45
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 01 trial | ||||||
| Phase 0 | NCT06119490 | Jul 2023 → Jul 2026 overdue | toxic epidermal necrolysis | Peng Zhang | Recruiting | No outcome recorded |
| Phase 118 trials | ||||||
| Phase 1 | NCT05067439 | Oct 2021 → Feb 2022 | — | Pfizer | Completed | No outcome recorded |
| Phase 1 | NCT04903093 | Jun → Oct 2021 | — | Pfizer | Completed | No outcome recorded |
| Phase 1 | NCT04099563 | Oct → Nov 2019 | — | Pfizer | Completed | No outcome recorded |
| Phase 1 | NCT04065633 | Jul → Dec 2019 | atopic eczema | Pfizer | Completed | No outcome recorded |
| Phase 1 | NCT03937258 | May → Jul 2019 | — | Pfizer | Completed | No outcome recorded |
| Phase 1 | NCT03806101 | Jan → Mar 2019 | — | Pfizer | Completed | No outcome recorded |
| Phase 1 | NCT03796182 | Jan → Feb 2019 | — | Pfizer | Completed | No outcome recorded |
| Phase 1 | NCT03742336 | Nov 2018 → Feb 2019 | — | Pfizer | Completed | No outcome recorded |
| Phase 1 | NCT03660241 | Oct 2018 → Nov 2019 | impaired renal function disease | Pfizer | Completed | No outcome recorded |
| Phase 1 | NCT03626415 | Oct 2018 → Apr 2019 | — | Pfizer | Completed | No outcome recorded |
| Phase 1 | NCT03662516 | Sep 2018 → Jan 2019 | — | Pfizer | Completed | No outcome recorded |
| Phase 1 | NCT03637790 | Sep → Dec 2018 | — | Pfizer | Completed | No outcome recorded |
| Phase 1 | NCT03634345 | Sep → Dec 2018 | atopic eczema | Pfizer | Completed | No outcome recorded |
| Phase 1 | NCT03647670 | Jul → Oct 2018 | — | Pfizer | Completed | No outcome recorded |
| Phase 1 | NCT03386279 | Jul → Oct 2018 | — | Pfizer | Completed | No outcome recorded |
| Phase 1 | NCT03250039 | Jul → Sep 2017 | — | Pfizer | Completed | No outcome recorded |
| Phase 1 | NCT02163161 | Jun → Aug 2014 | — | Pfizer | Completed | No outcome recorded |
| Phase 1 | NCT01835197 | May 2013 → Jun 2014 | — | Pfizer | Completed | No outcome recorded |
| Phase 210 trials · 3 met primary | ||||||
| Phase 2 | NCT07242638 | Jan 2026 → Mar 2027 expected | alopecia areata, atopic eczema | Icahn School of Medicine at Mount Sinai | Recruiting | No outcome recorded |
| Phase 2 | NCT06597396 | Dec 2024 → Mar 2026 overdue | post-COVID-19 disorder | Beth Israel Deaconess Medical Center | Active not recruiting | No outcome recorded |
| Phase 2 | NCT06283550 | May 2024 → Jun 2025 | — | Innovaderm Research Inc. | Completed | No outcome recorded |
| Phase 2 | NCT05650736 | Oct 2023 → May 2024 | granuloma annulare | William Damsky | Completed | No outcome recorded |
| Phase 2 | NCT05743244 | Oct 2023 → Oct 2026 expected | type 1 diabetes mellitus | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | Active not recruiting | No outcome recorded |
| Phase 2 | NCT05696795 | Jun 2023 → Apr 2025 | sarcoidosis | Yale University | Completed | No outcome recorded |
| Phase 2 | NCT05038982 | Sep 2021 → Jul 2022 | prurigo, prurigo nodularis | Johns Hopkins University | Completed | Met primary |
| Phase 2 | NCT03915496 | Jun 2020 → Nov 2021 | atopic eczema | Pfizer | Completed | No outcome recorded |
| Phase 2 | NCT02780167 | Apr 2016 → Mar 2017 | atopic eczema | Pfizer | Completed | Met primary |
| Phase 2 | NCT02201524 | Nov 2014 → Sep 2015 | psoriasis | Pfizer | Terminated | Met primary Stop: Business |
| Phase 311 trials · 6 met primary | ||||||
| Phase 3 | NCT07823595 | May 2027 → Apr 2029 expected | atopic eczema | Pfizer | Not yet recruiting | No outcome recorded |
| Phase 3 | NCT06807281 | Dec 2025 → Feb 2032 expected | atopic eczema | Pfizer | Recruiting | No outcome recorded |
| Phase 3 | NCT06807268 | Jul 2025 → May 2027 expected | atopic eczema | Pfizer | Recruiting | No outcome recorded |
| Phase 3 | NCT05375929 | Jul 2022 → Jun 2023 | atopic eczema | Pfizer | Completed | No outcome recorded |
| Phase 3 | NCT04345367 | Jun 2020 → Jul 2021 | atopic eczema | Pfizer | Completed | Met primary |
| Phase 3 | NCT03796676 | Feb 2019 → Apr 2020 | atopic eczema | Pfizer | Completed | Met primary |
| Phase 3 | NCT03720470 | Oct 2018 → Dec 2019 | atopic eczema | Pfizer | Completed | Met primary |
| Phase 3 | NCT03575871 | Jun 2018 → Aug 2019 | atopic eczema | Pfizer | Completed | Met primary |
| Phase 3 | NCT03627767 | Jun 2018 → Sep 2020 | IgE responsiveness, atopic, atopic eczema | Pfizer | Completed | Met primary |
| Phase 3 | NCT03422822 | Mar 2018 → Dec 2025 | atopic eczema | Pfizer | Completed | No outcome recorded |
| Phase 3 | NCT03349060 | Dec 2017 → Mar 2019 | atopic eczema | Pfizer | Completed | Met primary |
| Phase 44 trials | ||||||
| Phase 4 | NCT07848074 | Oct 2026 → May 2027 expected | atopic eczema | Fondazione Policlinico Universitario Agostino Gemelli IRCCS | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT07352566 | Aug 2026 → Jun 2030 expected | atopic eczema, psoriasis | University of California, San Francisco | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT06366932 | Sep 2023 → Sep 2025 | atopic eczema | Instituto de Investigación Hospital Universitario La Paz | Unknown | No outcome recorded |
| Phase 4 | NCT05602207 | Nov 2022 → Dec 2024 | atopic eczema | Innovaderm Research Inc. | Completed | No outcome recorded |
| Phase not stated1 trial | ||||||
| — | NCT04564755 | — | atopic eczema | Pfizer | No longer available | No outcome recorded |
| Comparator or background therapy2 trials | ||||||
| Phase 1 | NCT05069831 Comparator | May 2022 → Jun 2025 | food allergy | Icahn School of Medicine at Mount Sinai | Completed | No outcome recorded |
| — | NCT05466578 Background | — | atopic eczema | Pfizer | Available | No outcome recorded |
News releases announcing trial results or a regulatory action · 20
| Date | Issuer | Release |
|---|---|---|
| 2023-02-10 | Pfizer | Regulatory FDA Approves Pfizer's Supplemental New Drug Application for CIBINQO® (abrocitinib) pfizer.com ↗ |
| 2022-01-14 | Pfizer | Regulatory U.S. FDA Approves Pfizer’s CIBINQO® (abrocitinib) for Adults with Moderate-to-Severe Atopic Dermatitis pfizer.com ↗
CIBINQO is approved at the recommended doses of 100 mg and 200 mg, with the 200 mg dose being recommended for patients who are not responding to the 100 mg dose. |
| 2021-12-10 | Pfizer | Regulatory European Commission Approves Pfizer’s Cibinqo® (abrocitinib) for the Treatment of Adults with Moderate-to-Severe Atopic Dermatitis pfizer.com ↗
Pfizer Inc. (NYSE: PFE) today announced that the European Commission (EC) has approved the 100 mg and 200 mg doses of Cibinqo ® (abrocitinib), an oral, once-daily, Janus kinase 1 (JAK1) inhibitor, for the treatment of moderate-to-severe atopic dermatitis (AD) in adults who are candidates for systemic therapy. |
| 2021-10-15 | Pfizer | Regulatory Pfizer’s Abrocitinib Receives Positive CHMP Opinion for the Treatment of Adults with Moderate to Severe Atopic Dermatitis pfizer.com ↗
Pfizer Inc. (NYSE: PFE) today announced that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending the 100 mg and 200 mg doses of abrocitinib, an oral, once-daily, Janus kinase 1 (JAK1) inhibitor, for marketing authorization to treat moderate to severe atopic dermatitis (AD) in adults who are candidates for systemic therapy. |
| 2021-09-30 | Pfizer | Regulatory Japan’s MHLW Approves Pfizer’s CIBINQO® (abrocitinib) for Adults and Adolescents with Moderate to Severe Atopic Dermatitis pfizer.com ↗ |
| 2021-09-09 | Pfizer | Regulatory UK’s MHRA Grants Marketing Authorisation for Pfizer’s CIBINQO® (abrocitinib) for Adults and Adolescents With Moderate to Severe Atopic Dermatitis pfizer.com ↗
Pfizer Inc. (NYSE: PFE) today announced that the UK Medicines and Healthcare products Regulatory Agency (MHRA) has granted Great Britain marketing authorization for CIBINQO ® (abrocitinib), an oral, once-daily, Janus kinase 1 (JAK1) inhibitor, for the treatment of moderate to severe atopic dermatitis (AD) in adults and adolescents aged 12 years and over, who are candidates for systemic therapy. |
| 2021-08-30 | Pfizer | Results Positive Top-Line Results From Pfizer’s Phase 3 JADE DARE Trial Comparing the Efficacy of Abrocitinib and Dupilumab for Moderate to Severe Atopic Dermatitis pfizer.com ↗
The study showed that abrocitinib was statistically superior compared to dupilumab in each evaluated efficacy measure and had a safety profile consistent with previous studies. |
| 2021-07-21 | Pfizer | Regulatory Pfizer Provides Update on U.S. FDA Review of Abrocitinib and XELJANZ® Filings pfizer.com ↗
The FDA cited its ongoing review of Pfizer's post-marketing safety study, ORAL Surveillance, evaluating tofacitinib in rheumatoid arthritis patients, as a factor for the extensions. |
| 2021-04-07 | Pfizer | Regulatory Pfizer Announces Extension of Review of New Drug Application of Abrocitinib for the Treatment of Moderate to Severe Atopic Dermatitis pfizer.com ↗
Pfizer Inc. (NYSE: PFE) today announced that the U.S. Food and Drug Administration (FDA) has extended the priority review period for the New Drug Application (NDA) for abrocitinib for the treatment of adults and adolescents with moderate to severe atopic dermatitis. |
| 2021-03-25 | Pfizer | Results Results from Pfizer’s Phase 3 Jade Compare Study of Abrocitinib in Moderate to Severe Atopic Dermatitis Published in New England Journal of Medicine pfizer.com ↗
Both doses of abrocitinib met the co-primary study endpoints. |
| 2020-11-11 | Pfizer | Results Pfizer Announces Positive Results from Fifth Phase 3 Trial of Abrocitinib, Evaluating Safety and Efficacy Across Different Dosing Regimens pfizer.com ↗
Both doses of abrocitinib met the primary endpoint, resulting in significantly fewer patients experiencing a loss of response requiring rescue treatment, or “flaring,” compared to those randomized to placebo. |
| 2020-10-27 | Pfizer | Regulatory FDA Grants Priority Review and EMA Accepts Regulatory Submission for Pfizer’s Abrocitinib, an Oral Once-Daily JAK1 Inhibitor, for Patients 12 and Up with Moderate to Severe Atopic Dermatitis pfizer.com ↗
The European Medicines Agency (EMA) has also accepted the Marketing Authorization Application (MAA) for abrocitinib in the same patient population with a decision anticipated in the second half of 2021. |
| 2020-06-10 | Pfizer | Results Pfizer Announces Positive Top-Line Results from JADE TEEN Trial of Abrocitinib in Adolescents with Moderate-to-Severe Atopic Dermatitis pfizer.com ↗
Both doses of abrocitinib met the co-primary endpoints and were generally well tolerated. |
| 2020-06-03 | Pfizer | Results Complete Results from Second Pivotal Monotherapy Study of Abrocitinib Published in JAMA Dermatology pfizer.com ↗
Consistent with the first Phase 3 monotherapy study ( JADE MONO-1 ), both doses of abrocitinib met all co-primary and key secondary endpoints and were generally well tolerated. |
| 2020-03-18 | Pfizer | Results Pfizer Announces Positive Top-Line Results from Third Phase 3 Trial of Abrocitinib for Moderate to Severe Atopic Dermatitis, Which Showed Improvements in Skin Clearance, Disease Extent and Severity, and Itch pfizer.com ↗
Results showed that the percentage of patients achieving each co-primary efficacy endpoint at Week 12 was statistically superior with both doses of abrocitinib than with placebo. |
| 2020-03-18 | Pfizer | Results Pfizer Announces Positive Top-Line Results from Third Phase 3 Trial of Abrocitinib for Moderate to Severe Atopic Dermatitis, Which Showed Improvements in Skin Clearance, Disease Extent and Severity, and Itch pfizer.com ↗
Results showed that the percentage of patients achieving each co-primary efficacy endpoint at Week 12 was statistically superior with both doses of abrocitinib than with placebo. |
| 2019-10-12 | Pfizer | Results Pfizer Presents Positive Phase 3 Data at the 28th Congress of the European Academy of Dermatology and Venereology for Abrocitinib in Moderate to Severe Atopic Dermatitis pfizer.com ↗
Abrocitinib, an investigational oral Janus kinase 1 (JAK1) inhibitor, met all the co-primary and key secondary endpoints, which were related to skin clearance and itch relief compared to placebo. |
| 2019-09-27 | Pfizer | Results Pfizer Announces Positive Top-Line Results from Second Pivotal Phase 3 Study of Investigational Oral JAK1 Candidate, Abrocitinib, in Patients Aged 12 and Older with Moderate to Severe Atopic Dermatitis pfizer.com ↗
Consistent with JADE MONO-1, results showed that by week 12 the percentage of patients achieving each co-primary efficacy endpoint and each key secondary endpoint with either dose of abrocitinib was statistically significantly higher than placebo. |
| 2019-05-15 | Pfizer | Results Pfizer Announces Positive Top-Line Results from Phase 3 Study of Investigational Oral JAK1 Candidate, Abrocitinib (PF-04965842), in Patients Aged 12 and Older with Moderate to Severe Atopic Dermatitis pfizer.com ↗
Top-line results showed that by week 12 the percentage of patients achieving each co-primary efficacy endpoint and each key secondary endpoint with either dose of abrocitinib was statistically significantly higher than placebo. |
| 2018-02-14 | Pfizer | Regulatory Pfizer Receives Breakthrough Therapy Designation from FDA for PF-04965842, an oral JAK1 Inhibitor, for the Treatment of Patients with Moderate-to-Severe Atopic Dermatitis pfizer.com ↗
Pfizer Inc. (NYSE:PFE) today announced its once-daily oral Janus kinase 1 (JAK1) inhibitor PF-04965842 received Breakthrough Therapy designation from the U.S. Food and Drug Administration (FDA) for the treatment of patients with moderate-to-severe atopic dermatitis (AD). |
All press releases naming this drug 22 releases
Evidence & citations 7 cited values
Every value below carries the sentence it was read from. 51 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | abrocitinib | “Patients with moderate to severe atopic dermatitis refractory to topical medication, who also have previous experience with cyclosporine and an unsatisfactory response, or in...” NCT06366932 ↗27“BACKGROUND AND OBJECTIVE: Abrocitinib is an oral small-molecule Janus kinase (JAK)-1 inhibitor approved for the treatment of moderate-to-severe atopic dermatitis.” PMID 38554232 ↗ Mar 2024 “Abrocitinib is an oral once-daily Janus kinase 1 selective inhibitor being developed for the treatment of moderate-to-severe atopic dermatitis.” PMID 35701182 ↗ Jun 2022 “Abrocitinib (PF-04965842) is an oral Janus kinase 1 selective inhibitor under investigation for the treatment of atopic dermatitis.” PMID 31577341 ↗ Dec 2019 “Abrocitinib is a selective Janus kinase 1 inhibitor for the treatment of moderate-to-severe atopic dermatitis.” PMID 35342978 ↗ Apr 2022 “Abrocitinib is a Janus kinase 1-selective inhibitor for the treatment of moderate-to-severe atopic dermatitis.” PMID 35226304 ↗ Feb 2022 |
| Known as | Cibinqo | “Abrocitinib (Cibinqo) is FDA approved at 200 mg dose once daily for the treatment of atopic dermatitis.” NCT05696795 ↗1“Abrocitinib (Cibinqo) is FDA approved at 200 mg dose once daily for the treatment of atopic dermatitis.” NCT05650736 ↗ |
| Known as | PF-04965842 | “For subjects whose dose was changed from 200 mg Abrocitinib to 100 mg PF-04965842, one tablet will be administered to be taken orally once daily for the remainder of the study.” NCT03422822 ↗27“Abrocitinib (PF-04965842) is an oral Janus kinase 1 selective inhibitor under investigation for the treatment of atopic dermatitis.” PMID 31577341 ↗ Dec 2019 “PF 04965842 is a janus kinase (JAK) 1 inhibitor that is currently being developed for the treatment of atopic dermatitis (AD).” NCT03660241 ↗ “PF 04965842 is an orally bioavailable small molecule that selectively inhibits JAK1.” NCT03626415 ↗ “200 mg (2 × 100 mg) PF-04965842 Phase 3 tablet formulation under fasted conditions” NCT04065633 ↗ “evaluate the efficacy and safety of PF 04965842 in adolescent participants” NCT03796676 ↗ “Pre-approval Single-patient Expanded Access for Abrocitinib (PF-04965842)” NCT05466578 ↗ |
| Action | Inhibit | “Abrocitinib is a selective Janus kinase 1 inhibitor” PMID 35342978 ↗ Apr 2022 |
| Modality | Small molecule | “orally bioavailable small molecule” NCT03626415 ↗ |
| Route | Oral | “orally administered abrocitinib” PMID 35061234 ↗ Jan 2022 |
| Target | JAK1 | “JAK1 inhibitor” NCT02201524 ↗ |