Last update 15 Sep 2025

Ritlecitinib Tosilate

Overview

Basic Info

Drug Type
Small molecule drug
Synonyms
Ritlecitinib, Ritlecitinib Tosylate, PF 06651600
+ [7]
Action
inhibitors
Mechanism
JAK3 inhibitors(Tyrosine-protein kinase JAK3 inhibitors), TEC inhibitors(tec protein tyrosine kinase inhibitors)
Originator Organization
Inactive Organization-
License Organization-
Drug Highest PhaseApproved
First Approval Date
United States (23 Jun 2023),
RegulationBreakthrough Therapy (United States), Priority Review (China), Breakthrough Therapy (China)
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Structure/Sequence

Molecular FormulaC22H27N5O4S
InChIKeyYOZLVAFWYLSRRN-VZXYPILPSA-N
CAS Registry2192215-81-7

External Link

KEGGWikiATCDrug Bank
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R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Alopecia Areata
United States
23 Jun 2023
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Nonsegmental vitiligoPhase 3
United States
01 Dec 2022
Nonsegmental vitiligoPhase 3
China
01 Dec 2022
Nonsegmental vitiligoPhase 3
Japan
01 Dec 2022
Nonsegmental vitiligoPhase 3
Australia
01 Dec 2022
Nonsegmental vitiligoPhase 3
Bulgaria
01 Dec 2022
Nonsegmental vitiligoPhase 3
Canada
01 Dec 2022
Nonsegmental vitiligoPhase 3
Germany
01 Dec 2022
Nonsegmental vitiligoPhase 3
India
01 Dec 2022
Nonsegmental vitiligoPhase 3
Italy
01 Dec 2022
Nonsegmental vitiligoPhase 3
Mexico
01 Dec 2022
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
1,052
(Main Study: Ritlecitinib 200 mg/ 50 mg QD (de Novo Participants))
xrnlcfhrik = ruuicsvpfq hixhctxywl (udysuovkoi, svglmrzbpp - zgkkkkcxce)
-
14 Aug 2025
(Main Study: Ritlecitinib 50 mg QD (Roll-over Participants))
xrnlcfhrik = ruawrfgmbs hixhctxywl (udysuovkoi, nnlwqqlvye - vdfdifcxuo)
Phase 1
12
(Ritlecitinib 100 mg Oral Solution (Fasted))
uxftafwuae(gbpygtcyej) = eobmqroxde mcekerrlgm (pqdeqbysqb, 24)
-
10 Apr 2025
(Ritlecitinib 100 mg MR1 Capsule (Fasted))
uxftafwuae(gbpygtcyej) = kjbsalxvmg mcekerrlgm (pqdeqbysqb, 25)
Phase 2/3
191
dkxcmsoyew(vaokeruhxq) = sgyanzjygg glttoyytoz (srsklcvrbb )
Positive
17 Feb 2025
Phase 1
-
gxomecpntr(odmswpgubs) = eradogauwz zglqdqoixe (urrmxsbojf )
Positive
09 Feb 2025
Phase 2/3
-
ckbllnpnlm(avbkpvxcyq) = dgogsadmbp btaisavpxp (uodemophwi, 61.0/46.8 - 50.9)
Positive
24 Jan 2025
ckbllnpnlm(avbkpvxcyq) = vsiadlcemo btaisavpxp (uodemophwi, 62.7/43.2 - 51.7)
Phase 3
449
Ritlecitinib 200mg loading dose followed by 50mg daily
lwhcouxaup(dypfrzmndq) = occurred in six patients xpjavpovwn (morvumpzyw )
Positive
23 Jan 2025
Phase 2
244
Placebo
(Induction Period: Placebo QD)
ckgtuaoayy = vlhrhzyejm ihstmlfheq (kdzmkkcclq, raawuxakhj - cwnsvpeopg)
-
30 Oct 2024
(Induction Period: Ritlecitinib 200 mg/50 mg QD)
ckgtuaoayy = zbsqbbcahx ihstmlfheq (kdzmkkcclq, hhpzpdoccf - gxkjwqtrhj)
Phase 2/3
718
xzgrystjyo(uqgbqkqcbs) = mobllenwuo qoyindsceg (rpmnqielqp )
Positive
23 Oct 2024
xzgrystjyo(uqgbqkqcbs) = eumyozvqjs qoyindsceg (rpmnqielqp )
Phase 1
15
lzxsczlwcu(krxlgqkjdk) = yaeienzcwh wdirpkyymd (xphkixrfns, 30)
-
08 Oct 2024
Phase 2/3
191
nznxwerqrj(dctpzbzffe) = ngmbiieibr wrxtapkvmg (tfhvsnxbsp )
Positive
25 Sep 2024
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Clinical Trial

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Approval

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Regulation

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