Drugs / Ritlecitinib
Ritlecitinib
also known as
PF-06651600 · Litfulo · Pf-06651600 tosylate · Ritlecitinib tosilate · Ritlecitinib toslate · RITLECITINIB TOSYLATE
Small molecule targets JAK3, TEC via inhibition
Regulatory milestones approvals, filings & regulatory actions · 2 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Approved | EU (EMA) | Litfulo | — | 2023-09-15 | europa.eu ↗ |
| Approved | US (FDA) | LITFULO | — | 2023-06-23 | fda.gov ↗ |
Trials 46 · a red edge is where a trial was stopped
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 124 trials | ||||||
| Phase 1 | NCT06369454 | May → Jul 2024 | — | Pfizer | Completed | No outcome recorded |
| Phase 1 | NCT06172348 | Feb → Mar 2024 | — | Pfizer | Completed | No outcome recorded |
| Phase 1 | NCT05650333 | Mar → Aug 2023 | alopecia areata | Pfizer | Completed | No outcome recorded |
| Phase 1 | NCT05097716 | Nov 2021 → Jan 2022 | — | Pfizer | Completed | No outcome recorded |
| Phase 1 | NCT05128058 | Oct 2021 → Jan 2022 | — | Pfizer | Completed | No outcome recorded |
| Phase 1 | NCT05040295 | Sep → Nov 2021 | — | Pfizer | Completed | No outcome recorded |
| Phase 1 | NCT04655040 | Dec 2020 → Mar 2021 | — | Pfizer | Completed | No outcome recorded |
| Phase 1 | NCT04634565 | Oct → Nov 2020 | — | Pfizer | Completed | No outcome recorded |
| Phase 1 | NCT04266509 | Jun → Sep 2020 | — | Pfizer | Completed | No outcome recorded |
| Phase 1 | NCT04355845 | Jun → Aug 2020 | — | Pfizer | Completed | No outcome recorded |
| Phase 1 | NCT04092595 | Sep 2019 → Jan 2020 | — | Pfizer | Completed | No outcome recorded |
| Phase 1 | NCT04037865 | Aug 2019 → Mar 2020 | impaired renal function disease | Pfizer | Terminated | No outcome recorded |
| Phase 1 | NCT04018274 | Aug → Oct 2019 | — | Pfizer | Completed | No outcome recorded |
| Phase 1 | NCT04016077 | Jul 2019 → Mar 2020 | — | Pfizer | Completed | No outcome recorded |
| Phase 1 | NCT04004663 | Jul → Oct 2019 | — | Pfizer | Completed | No outcome recorded |
| Phase 1 | NCT03929510 | Apr → Jul 2019 | — | Pfizer | Completed | No outcome recorded |
| Phase 1 | NCT03916393 | Apr → May 2019 | — | Pfizer | Completed | No outcome recorded |
| Phase 1 | NCT03821493 | Feb → Apr 2019 | — | Pfizer | Completed | No outcome recorded |
| Phase 1 | NCT03827668 | Feb → Apr 2019 | — | Pfizer | Completed | No outcome recorded |
| Phase 1 | NCT03762928 | Dec 2018 → Jan 2019 | — | Pfizer | Completed | No outcome recorded |
| Phase 1 | NCT03608241 | Sep → Nov 2018 | — | Pfizer | Completed | No outcome recorded |
| Phase 1 | NCT03232905 | Aug → Oct 2017 | — | Pfizer | Completed | No outcome recorded |
| Phase 1 | NCT02684760 | Feb → May 2016 | — | Pfizer | Completed | No outcome recorded |
| Phase 1 | NCT02309827 | Dec 2014 → Apr 2016 | — | Pfizer | Completed | No outcome recorded |
| Phase 214 trials | ||||||
| Phase 2 | NCT06795373 | Dec 2025 → Mar 2026 | chronic idiopathic urticaria | Ahuva D Cices | Withdrawn | No outcome recorded |
| Phase 2 | NCT07228390 | Nov 2025 → Mar 2027 expected | hidradenitis suppurativa | Pfizer | Recruiting | No outcome recorded |
| Phase 2 | NCT07219615 | Oct 2025 → Dec 2026 expected | chronic urticaria | Pfizer | Recruiting | No outcome recorded |
| Phase 2 | NCT06373458 | Aug 2024 → Aug 2027 expected | keloid | Icahn School of Medicine at Mount Sinai | 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 | NCT05879458 | May 2023 → Jun 2025 | Sezary syndrome, mycosis fungoides | Icahn School of Medicine at Mount Sinai | Terminated | No outcome recorded |
| Phase 2 | NCT05549934 | Dec 2022 → Mar 2025 | alopecia | Emma Guttman | Completed | No outcome recorded |
| Phase 2 | NCT04517864 | Sep 2020 → Jan 2022 | alopecia areata | Pfizer | Terminated | No outcome recorded |
| Phase 2 | NCT04413617 | Jul 2020 → Feb 2022 | rheumatoid arthritis | Pfizer | Completed | No outcome recorded |
| Phase 2 | NCT03715829 | Nov 2018 → Feb 2021 | vitiligo | Pfizer | Completed | No outcome recorded |
| Phase 2 | NCT03395184 | Feb 2018 → Oct 2023 | Crohn disease | Pfizer | Completed | No outcome recorded |
| Phase 2 | NCT02958865 | Feb 2017 → May 2021 | ulcerative colitis | Pfizer | Completed | No outcome recorded |
| Phase 2 | NCT02969044 | Dec 2016 → Dec 2017 | rheumatoid arthritis | Pfizer | Completed | No outcome recorded |
| Phase 2 | NCT02974868 | Dec 2016 → May 2019 | alopecia areata | Pfizer | Completed | No outcome recorded |
| Phase 37 trials | ||||||
| Phase 3 | NCT07029828 | Sep 2025 → Jun 2030 expected | alopecia areata | Pfizer | Recruiting | No outcome recorded |
| Phase 3 | NCT07029711 | Jul 2025 → Dec 2026 expected | alopecia areata | Pfizer | Active not recruiting | No outcome recorded |
| Phase 3 | NCT06873945 | Apr 2025 → Dec 2026 expected | alopecia areata | Pfizer | Active not recruiting | No outcome recorded |
| Phase 3 | NCT06163326 | Jan 2024 → Mar 2027 expected | vitiligo | Pfizer | Active not recruiting | No outcome recorded |
| Phase 3 | NCT06072183 | Nov 2023 → Jul 2027 expected | vitiligo | Pfizer | Active not recruiting | No outcome recorded |
| Phase 3 | NCT05583526 | Dec 2022 → Feb 2026 | vitiligo | Pfizer | Completed | No outcome recorded |
| Phase 3 | NCT04006457 | Jul 2019 → Jun 2024 | alopecia areata | Pfizer | Completed | No outcome recorded |
| Phase not stated1 trial | ||||||
| — | NCT05522556 | — | alopecia areata | Pfizer | Available | No outcome recorded |
Also used as a comparator or background therapy in 3 trials
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial | ||||||
| Phase 1 | NCT05852340 Comparator | May → Jun 2023 | — | Pfizer | Completed | No outcome recorded |
| Phase 22 trials | ||||||
| Phase 2 | NCT07152626 Comparator | Mar 2026 → Jan 2029 expected | vitiligo | Centre Hospitalier Universitaire de Nice | Recruiting | No outcome recorded |
| Phase 2 | NCT05636293 Comparator | Mar 2023 → Dec 2025 | celiac disease | Massachusetts General Hospital | Completed | No outcome recorded |
Press releases naming this drug 7 releases
| Date | Issuer | Release |
|---|---|---|
| 2026-07-30 | Pfizer | Pfizer Announces Positive Topline Phase 3 Results for LITFULO in Patients with Nonsegmental Vitiligo pfizer.com ↗ |
| 2023-09-19 | Pfizer | European Commission Approves Pfizer’s LITFULO™ for Adolescents and Adults With Severe Alopecia Areata pfizer.com ↗ |
| 2023-06-23 | Pfizer | FDA Approves Pfizer’s LITFULO™ (Ritlecitinib) for Adults and Adolescents With Severe Alopecia Areata pfizer.com ↗ |
| 2022-09-09 | Pfizer | FDA and EMA Accept Regulatory Submission for Pfizer’s Ritlecitinib for Individuals 12 Years and Older with Alopecia Areata pfizer.com ↗ |
| 2021-08-04 | Pfizer | Pfizer Announces Positive Top-Line Results from Phase 2b/3 Trial of Ritlecitinib in Alopecia Areata pfizer.com ↗ |
| 2019-01-03 | Pfizer | Pfizer Initiates Phase 2b/3 Clinical Trial for PF-06651600, an Oral JAK3 Inhibitor, for the Treatment of Patients with Moderate to Severe Alopecia Areata pfizer.com ↗ |
| 2018-09-05 | Pfizer | Pfizer Receives Breakthrough Therapy Designation from FDA for PF-06651600, an oral JAK3 Inhibitor, for the Treatment of Patients with Alopecia Areata pfizer.com ↗ |
Evidence & citations 11 cited values
Every value below carries the sentence it was read from. 54 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | ritlecitinib | “To evaluate the efficacy and safety of PF-06651600 (ritlecitinib), an irreversible inhibitor of JAK3 and the tyrosine kinase expressed in hepatocellular carcinoma (TEC) kinase...” PMID 32419304 ↗ Sep 202028“Ritlecitinib is an oral Janus kinase 3/tyrosine kinase expressed in hepatocellular carcinoma family inhibitor undergoing parallel clinical development for alopecia areata,...” PMID 37917289 ↗ Nov 2023 “Ritlecitinib, an oral Janus kinase 3/tyrosine kinase expressed in hepatocellular carcinoma family inhibitor, was evaluated in patients with ulcerative colitis (UC) in a phase 2b trial.” PMID 38627914 ↗ Apr 2024 “Ritlecitinib, an orally administered inhibitor of JAK3 (Janus kinase)/ TEC (tyrosine kinase expressed in hepatocellular carcinoma)” NCT07152626 ↗ “Ritlecitinib, a JAK3/TEC family kinase inhibitor, stabilizes active lesions and repigments stable lesions in vitiligo.” PMID 39023568 ↗ Jul 2024 “single oral administration of ritlecitinib 200 milligram (mg) tablet” NCT04655040 ↗ “Ritlecitinib, an oral JAK3/TEC family kinase inhibitor” PMID 41917311 ↗ Mar 2026 “PF-06651600 (RITLECITINIB)” NCT04413617 ↗ |
| Known as | Litfulo | ChEMBL registry synonym — accepted as the source's own label CHEMBL4085457 ↗ |
| Known as | PF-06651600 | “Pre-approval Single-patient Expanded Access for Ritlecitinib (PF-06651600)” NCT05522556 ↗24“Ritlecitinib (PF-06651600)” NCT05879458 ↗ |
| Known as | Pf-06651600 tosylate | ChEMBL registry synonym — accepted as the source's own label CHEMBL4085457 ↗ |
| Known as | Ritlecitinib tosilate | ChEMBL registry synonym — accepted as the source's own label CHEMBL4085457 ↗ |
| Known as | Ritlecitinib toslate | ChEMBL registry synonym — accepted as the source's own label CHEMBL4085457 ↗ |
| Known as | RITLECITINIB TOSYLATE | ChEMBL registry synonym — accepted as the source's own label CHEMBL4085457 ↗ |
| Action | Inhibit | “PF-06651600, a newly discovered potent JAK3-selective inhibitor” PMID 27791347 ↗ Nov 2016 |
| Modality | Small molecule | “Ritlecitinib, an oral JAK3/TEC family kinase inhibitor” PMID 41917311 ↗ Mar 2026 |
| Route | Oral | “Delivered orally for 8 weeks.” NCT02958865 ↗ |
| Target | JAK3 | “PF-06651600, a newly discovered potent JAK3-selective inhibitor” PMID 27791347 ↗ Nov 2016 |