ritlecitinib

Trade name: Litfulo

Small moleculeapproved

Approved

Jun 23, 2023

Clinical trial activity

51 trials · 6 clinical orgs · 1 marketing orgs

Phase 1
26
Phase 2
23
Phase 3
9
Phase 4
0

Earliest trial started Oct 1, 2011 (NCT01452373)

Timeline

2010s

  1. Jan 1, 2011

    Earliest Phase 3 Sponsor(trial)

  2. Jan 1, 2014

    Pfizer — Earliest Phase 1 Sponsor(trial)

  3. Jan 1, 2016

    Pfizer — Earliest Phase 2 Sponsor(trial)

2020s

  1. Jun 23, 2023

    Pfizer — Earliest FDA Approval

  2. Jun 23, 2023

    Pfizer — Marketing Organization

  3. Jun 23, 2023

    Pfizer — NDA Secondary Org

  4. Jun 23, 2023

    Pfizer — NDA Organization

Indications

Mechanism of action

Approval history

  • approvedJun 23, 2023

Chemistry & pharmacology

Loading structure…

SMILES

C=CC(=O)N1C[C@H](Nc2ncnc3[nH]ccc23)CC[C@@H]1C
Mol. weight
285.35 g/mol
Lipinski Ro5
Pass
Rule of 3
No
Chirality
Single Stereoisomer
Inorganic
No
Polymer
No
Delivery
Oral
Availability
Prescription Only

Oral

Yes

Parenteral

No

Topical

No

Black box warning

Sources

Also known as

  • 1,1'-((1,3,6,8-tetrahydro-1,3,6,8-tetraoxobenzo(lmn)(3,8)phenanthroline-2,7-diyl)di-4,1-phenylene)bis(1-ethylpiperidinium),
  • acolbifene
  • acolbifene
  • acolbifene
  • acolbifene
  • bis(4-piperidinophenol)diimidonaphthalene-1,4,5,8-tetracarboxylic acid dibenzosulfoethylate
  • bis(p-piperidinophenol)diimidonaphthalene-1,4,5,8-tetracarboxylic acid dibenzosulfoethylate
  • em 652
  • em-652
  • em-652
  • em-652
  • iem 652
  • pf-06651600
  • pf-06651600
  • ritebronii
  • ritebronium
  • ritetronium
  • ritetronium dibenzenesulfonate
  • ritetroniy
  • sch57068
  • sch 57068
  • sch-57068
  • sch-57068

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT07228390Phase 2Nov 13, 2025Pfizer
NCT07219615Phase 2Oct 30, 2025Pfizer
NCT07029828Phase 3Sep 10, 2025Pfizer
NCT07029711Phase 3Jul 31, 2025Pfizer
NCT06873945Phase 3Apr 1, 2025Pfizer
NCT06795373Phase 2Feb 28, 2025Icahn School of Medicine at Mount Sinai
NCT06373458Phase 2Aug 13, 2024Icahn School of Medicine at Mount Sinai, Pfizer
NCT06369454Phase 1May 3, 2024Pfizer
NCT06172348Phase 1Jan 2, 2024Pfizer
NCT06163326Phase 3Dec 22, 2023Pfizer
NCT06072183Phase 3Nov 8, 2023Pfizer
NCT05743244Phase 2Oct 19, 2023National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Pfizer
NCT05879458Phase 2May 17, 2023Icahn School of Medicine at Mount Sinai, Pfizer
NCT05852340Phase 1May 9, 2023Pfizer
NCT05650333Phase 1Jan 16, 2023Pfizer
NCT05636293Phase 2Jan 1, 2023Harvard University, Pfizer
NCT05583526Phase 3Dec 1, 2022Pfizer
NCT05549934Phase 2Sep 30, 2022Icahn School of Medicine at Mount Sinai, Pfizer
NCT05097716Phase 1Nov 2, 2021Pfizer
NCT05128058Phase 1Oct 22, 2021Pfizer
Showing 20 of 51 trials
Page 1 / 3

Organizations

Research & Development (6)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
PfizerFor profit494442014
Icahn School of Medicine at Mount SinaiAcademic/Hospital4412022
EndoCeutics Inc.For profit1112011
Harvard UniversityAcademic/Hospital1112023
Laval UniversityAcademic/Hospital1012011
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Government1112023
6 organizations
Page 1 / 1

Marketing (4)

OrganizationOrg typeRelationshipDate
PfizerFor profitMKTGJun 23, 2023
PfizerFor profitSYNJun 23, 2023
PfizerFor profitNDA2Jun 23, 2023
PfizerFor profitNDAJun 23, 2023