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 · 7 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed alopecia areata 5 milestones | |||||
| Filed | China (NMPA) | — | alopecia areata | 2022-09-09 | “Pfizer has also completed regulatory submissions for ritlecitinib in the United Kingdom, China and Japan” pfizer.com ↗ |
| Filed | EU (EMA) | — | alopecia areata | 2022-09-09 | “The European Medicines Agency (EMA) has also accepted the Marketing Authorization Application (MAA) for ritlecitinib in the same patient population” pfizer.com ↗ |
| Filed | Japan (PMDA) | — | alopecia areata | 2022-09-09 | “Pfizer has also completed regulatory submissions for ritlecitinib in the United Kingdom, China and Japan” pfizer.com ↗ |
| Filed | UK (MHRA) | — | alopecia areata | 2022-09-09 | “Pfizer has also completed regulatory submissions for ritlecitinib in the United Kingdom, China and Japan” pfizer.com ↗ |
| Filed | US (FDA) | — | alopecia areata | 2022-09-09 | “The U.S. Food and Drug Administration (FDA) accepted for filing the New Drug Application (NDA) for ritlecitinib for adults and adolescents 12 years of age and older with...” pfizer.com ↗ |
| Approved Indication not stated 2 milestones | |||||
| Approved | EU (EMA) | Litfulo | — | 2023-09-15 | europa.eu ↗ |
| Approved | US (FDA) | LITFULO | — | 2023-06-23 | fda.gov ↗ |
Trials 47
| 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 · 5 met primary | ||||||
| Phase 2 | NCT06795373 | Dec 2025 → Mar 2026 | chronic idiopathic urticaria | Ahuva D Cices | Withdrawn | No outcome recorded |
| Phase 2 | NCT07228390 | Nov 2025 → Dec 2026 expected | hidradenitis suppurativa | Pfizer | Active not 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 → 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 | 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 Stop: Business |
| Phase 2 | NCT04413617 | Jul 2020 → Feb 2022 | rheumatoid arthritis | Pfizer | Completed | Mixed |
| Phase 2 | NCT03715829 | Nov 2018 → Feb 2021 | vitiligo | Pfizer | Completed | Met primary |
| Phase 2 | NCT03395184 | Feb 2018 → Oct 2023 | Crohn disease | Pfizer | Completed | Met primary |
| Phase 2 | NCT02958865 | Feb 2017 → May 2021 | ulcerative colitis | Pfizer | Completed | Met primary |
| Phase 2 | NCT02969044 | Dec 2016 → Dec 2017 | rheumatoid arthritis | Pfizer | Completed | Met primary |
| Phase 2 | NCT02974868 | Dec 2016 → May 2019 | alopecia areata | Pfizer | Completed | Met primary |
| Phase 38 trials · 2 met primary | ||||||
| Phase 3 | NCT07733765 | Jul 2026 → Apr 2028 expected | alopecia areata | Pfizer | Recruiting | No outcome recorded |
| 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 → Mar 2028 expected | alopecia areata | Pfizer | 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 | Met primary |
| Phase 3 | NCT05583526 | Dec 2022 → Feb 2026 | vitiligo | Pfizer | Completed | Met primary |
| 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 |
| Comparator or background therapy3 trials | ||||||
| Phase 1 | NCT05852340 Comparator | May → Jun 2023 | — | Pfizer | Completed | No outcome recorded |
| 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 → Apr 2026 | celiac disease | Massachusetts General Hospital | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 8
| Date | Issuer | Release |
|---|---|---|
| 2026-10-02 | Pfizer | Results Pfizer’s LITFULO Significantly Improved Facial and Total Body Repigmentation in Patients with Nonsegmental Vitiligo pfizer.com ↗
In the two studies, TRANQUILLO 2 and TRANQUILLO, LITFULO 100 mg and 50 mg, respectively, significantly improved facial and total body repigmentation compared to placebo. |
| 2026-07-30 | Pfizer | Results Pfizer Announces Positive Topline Phase 3 Results for LITFULO in Patients with Nonsegmental Vitiligo pfizer.com ↗
Two pivotal studies of LITFULO™ (ritlecitinib) in nonsegmental vitiligo met their co-primary endpoints, showing significant improvement in facial and total repigmentation versus placebo at Week 52 |
| 2023-09-19 | Pfizer | Regulatory European Commission Approves Pfizer’s LITFULO™ for Adolescents and Adults With Severe Alopecia Areata pfizer.com ↗
Pfizer Inc. (NYSE: PFE) today announced that the European Commission (EC) has granted marketing authorization for LITFULO™ (ritlecitinib) to treat adults and adolescents 12 years of age and older with severe alopecia areata. |
| 2023-06-23 | Pfizer | Regulatory FDA Approves Pfizer’s LITFULO™ (Ritlecitinib) for Adults and Adolescents With Severe Alopecia Areata pfizer.com ↗
Pfizer Inc. (NYSE: PFE) announced today that the U.S. Food and Drug Administration (FDA) has approved LITFULO ™ (ritlecitinib), a once-daily oral treatment, for individuals 12 years of age and older with severe alopecia areata. |
| 2022-09-09 | Pfizer | Regulatory FDA and EMA Accept Regulatory Submission for Pfizer’s Ritlecitinib for Individuals 12 Years and Older with Alopecia Areata pfizer.com ↗
Pfizer Inc. (NYSE: PFE) announced today that the U.S. Food and Drug Administration (FDA) accepted for filing the New Drug Application (NDA) for ritlecitinib for adults and adolescents 12 years of age and older with alopecia areata. |
| 2021-08-04 | Pfizer | Results Pfizer Announces Positive Top-Line Results from Phase 2b/3 Trial of Ritlecitinib in Alopecia Areata pfizer.com ↗
The Phase 2b/3 ALLEGRO trial met the primary efficacy endpoint of improving scalp hair regrowth. |
| 2018-09-14 | Pfizer | Results Pfizer Presents Positive Phase 2 Data in Alopecia Areata During Late-Breaker Session at the 27th European Academy of Dermatology and Venereology (EADV) Congress pfizer.com ↗
The findings were presented during a Late-Breaking News session at the 27th European Academy of Dermatology and Venereology (EADV) Congress in Paris, France. |
| 2018-09-05 | Pfizer | Regulatory Pfizer Receives Breakthrough Therapy Designation from FDA for PF-06651600, an oral JAK3 Inhibitor, for the Treatment of Patients with Alopecia Areata pfizer.com ↗
Pfizer Inc. (NYSE:PFE) today announced its investigational oral Janus kinase 3 (JAK3) inhibitor PF-06651600 received Breakthrough Therapy designation from the U.S. Food and Drug Administration (FDA) for the treatment of patients with alopecia areata, a chronic autoimmune skin disease that causes hair loss on the scalp, face, or body. |
All press releases naming this drug 9 releases
Evidence & citations 11 cited values
Every value below carries the sentence it was read from. 55 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 202029“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 ↗ |
| 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 |