Drugs / Abrocitinib
Regulatory milestones approvals, filings & regulatory actions · 4 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| 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 43 · a red edge is where a trial was stopped
| 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 | ||||||
| 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 overdue | granuloma annulare | William Damsky | Active not recruiting | No outcome recorded |
| Phase 2 | NCT05743244 | Oct 2023 → Jun 2026 overdue | 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 | No outcome recorded |
| 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 | No outcome recorded |
| Phase 2 | NCT02201524 | Nov 2014 → Sep 2015 | psoriasis | Pfizer | Terminated | No outcome recorded |
| Phase 310 trials | ||||||
| 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 | No outcome recorded |
| Phase 3 | NCT03796676 | Feb 2019 → Apr 2020 | atopic eczema | Pfizer | Completed | No outcome recorded |
| Phase 3 | NCT03720470 | Oct 2018 → Dec 2019 | atopic eczema | Pfizer | Completed | No outcome recorded |
| Phase 3 | NCT03575871 | Jun 2018 → Aug 2019 | atopic eczema | Pfizer | Completed | No outcome recorded |
| Phase 3 | NCT03627767 | Jun 2018 → Sep 2020 | IgE responsiveness, atopic, atopic eczema | Pfizer | Completed | No outcome recorded |
| 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 | No outcome recorded |
| Phase 43 trials | ||||||
| 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 |
Also used as a comparator or background therapy in 2 trials
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial | ||||||
| Phase 1 | NCT05069831 Comparator | May 2022 → Jun 2025 | food allergy | Icahn School of Medicine at Mount Sinai | Completed | No outcome recorded |
| Phase not stated1 trial | ||||||
| — | NCT05466578 Background | — | atopic eczema | Pfizer | Available | No outcome recorded |
Press releases naming this drug 21 releases
| Date | Issuer | Release |
|---|---|---|
| 2023-02-10 | Pfizer | FDA Approves Pfizer's Supplemental New Drug Application for CIBINQO® (abrocitinib) pfizer.com ↗ |
| 2022-01-14 | Pfizer | U.S. FDA Approves Pfizer’s CIBINQO® (abrocitinib) for Adults with Moderate-to-Severe Atopic Dermatitis pfizer.com ↗ |
| 2021-12-10 | Pfizer | European Commission Approves Pfizer’s Cibinqo® (abrocitinib) for the Treatment of Adults with Moderate-to-Severe Atopic Dermatitis pfizer.com ↗ |
| 2021-10-15 | Pfizer | Pfizer’s Abrocitinib Receives Positive CHMP Opinion for the Treatment of Adults with Moderate to Severe Atopic Dermatitis pfizer.com ↗ |
| 2021-09-30 | Pfizer | Japan’s MHLW Approves Pfizer’s CIBINQO® (abrocitinib) for Adults and Adolescents with Moderate to Severe Atopic Dermatitis pfizer.com ↗ |
| 2021-09-09 | Pfizer | UK’s MHRA Grants Marketing Authorisation for Pfizer’s CIBINQO® (abrocitinib) for Adults and Adolescents With Moderate to Severe Atopic Dermatitis pfizer.com ↗ |
| 2021-08-30 | Pfizer | 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 ↗ |
| 2021-07-21 | Pfizer | Pfizer Provides Update on U.S. FDA Review of Abrocitinib and XELJANZ® Filings pfizer.com ↗ |
| 2021-04-07 | Pfizer | Pfizer Announces Extension of Review of New Drug Application of Abrocitinib for the Treatment of Moderate to Severe Atopic Dermatitis pfizer.com ↗ |
| 2021-03-25 | Pfizer | 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 ↗ |
| 2020-11-11 | Pfizer | Pfizer Announces Positive Results from Fifth Phase 3 Trial of Abrocitinib, Evaluating Safety and Efficacy Across Different Dosing Regimens pfizer.com ↗ |
| 2020-10-27 | Pfizer | 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 ↗ |
| 2020-06-10 | Pfizer | Pfizer Announces Positive Top-Line Results from JADE TEEN Trial of Abrocitinib in Adolescents with Moderate-to-Severe Atopic Dermatitis pfizer.com ↗ |
| 2020-06-03 | Pfizer | Complete Results from Second Pivotal Monotherapy Study of Abrocitinib Published in JAMA Dermatology pfizer.com ↗ |
| 2020-03-18 | Pfizer | 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 ↗ |
| 2020-03-18 | Pfizer | 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 ↗ |
| 2019-10-12 | Pfizer | 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 ↗ |
| 2019-09-27 | Pfizer | 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 ↗ |
| 2019-05-15 | Pfizer | 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 ↗ |
| 2018-02-14 | Pfizer | 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 ↗ |
| 2017-12-14 | Pfizer | Pfizer Initiates Phase 3 Program for PF-04965842, a JAK1 Inhibitor in Development for Moderate-to-Severe Atopic Dermatitis pfizer.com ↗ |
Evidence & citations 7 cited values
Every value below carries the sentence it was read from. 49 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 ↗25“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.” NCT05650736 ↗1“Abrocitinib (Cibinqo) is FDA approved at 200 mg dose once daily for the treatment of atopic dermatitis.” NCT05696795 ↗ |
| 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 ↗ “Pre-approval Single-patient Expanded Access for Abrocitinib (PF-04965842)” NCT05466578 ↗ “Drug: PF04965842” NCT03796676 ↗ |
| 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 ↗ |