baricitinib

Trade name: olumiant

Small moleculeapproved

Approved

May 31, 2018

Baricitinib (trade name Olumiant) is an investigational drug for rheumatoid arthritis (RA), being developed by Incyte and Eli Lilly. Baricitinib is a selective JAK1 and JAK2 inhibitor with IC50 of 5.9 nM and 5.7 nM in cell-free assays. In February 2017 Baricitinib was approved for use in the European Union as a second-line therapy for moderate to severe active rheumatoid arthritis in adults, either alone or in combination with methotrexate. On 31 May 2018 FDA approved Barictinib for the treatment of adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response to one or more TNF antagonist therapies. — NCATS

Clinical trial activity

148 trials · 97 clinical orgs · 3 marketing orgs

Phase 1
27
Phase 2
100
Phase 3
52
Phase 4
10

Earliest trial started May 1, 2009 (NCT00902486)

Timeline

2000s

  1. Jan 1, 2009

    Earliest Phase 2 Sponsor(trial)

2010s

  1. Jan 1, 2010

    Eli Lilly — Earliest Phase 1 Sponsor(trial)

  2. Jan 1, 2012

    Eli Lilly — Earliest Phase 3 Sponsor(trial)

  3. May 31, 2018

    Eli Lilly — Earliest FDA Approval

  4. May 31, 2018

    Eli Lilly — NDA Secondary Org

  5. May 31, 2018

    Eli Lilly — NDA Organization

2020s

  1. Jul 22, 2024

    Aurobindo Pharma — Marketing Organization

  2. Aug 8, 2025

    MSN Laboratories — Marketing Organization

Indications

Studied for

Mechanism of action

Approval history

  • approvedMay 31, 2018

Chemistry & pharmacology

Loading structure…

SMILES

CCS(=O)(=O)N1CC(CC#N)(C1)N2C=C(C=N2)C3=C4C=CNC4=NC=N3
Mol. weight
371.417 g/mol
Lipinski Ro5
Pass
Rule of 3
No
Chirality
Achiral Molecule
Inorganic
No
Polymer
No
Delivery
Oral
Availability
Prescription Only

Oral

Yes

Parenteral

No

Topical

No

Black box warning

Sources

Also known as

  • baricitinib
  • baricitinib
  • baricitinib
  • baricitinib
  • baricitinib
  • baricitinib
  • baricitinib
  • baricitinib
  • incb028050
  • incb028050
  • incb028050
  • incb-028050
  • incb-028050
  • incb-28050
  • incb-28050
  • ly3009104
  • ly3009104
  • ly3009104
  • ly-3009104
  • ly-3009104

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT07081763Phase 2May 31, 2026Government of France
NCT07268534Phase 2Apr 1, 2026Assistance Publique - Hôpitaux de Paris
NCT07222332Phase 3Mar 31, 2026Eli Lilly
NCT07222137Phase 3Jan 31, 2026Eli Lilly
NCT07262983Phase 1Dec 14, 2025National Institute of Allergy and Infectious Diseases (NIAID)
NCT07279688Phase 3Dec 12, 2025Eli Lilly, University of Western Brittany
NCT06923072Phase 2Dec 2, 2025National Heart, Lung, and Blood Institute (NHLBI)
NCT07209267Phase 2Nov 30, 2025Eli Lilly, Emory University
NCT07028385Phase 2Sep 30, 2025Badalona Hospital Germans Trias i Pujol, FUNDACIÓN FLS DE LUCHA CONTRA EL SIDA, LAS ENFERMEDADES INFECCIOSAS Y LA PROMOCIÓN DE LA SALUD Y LA CIENCIA, IrsiCaixa, Universidad Carlos III Madrid, University of Turin
NCT07003997Phase 2Sep 3, 2025Emory University, National Institute of Mental Health (NIMH)
NCT06868381Phase 2Apr 1, 2025Eli Lilly, Stanford University
NCT06768294Phase 2Jan 31, 2025I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio
NCT06797310Phase 2Jan 23, 2025Eli Lilly, National Taiwan University
NCT06687551Phase 4Jan 1, 2025University of Toulouse
NCT06737705Phase 2Dec 18, 2024Fujian Medical University, Tianjin Medical University
NCT06849908Phase 2Nov 8, 2024Chinese Academy of Medical Sciences
NCT06631287Phase 3Oct 11, 2024National Institute on Aging (NIA), National Institutes of Health (NIH), Vanderbilt University
NCT06768840Phase 2/Phase 3 (Phase 3)Oct 2, 2024South Valley University
NCT06490757Phase 2Sep 2, 2024Assistance Publique - Hôpitaux de Paris
NCT06439615Phase 2Aug 1, 2024People's Liberation Army of China, Tangdu Hospital
Showing 20 of 148 trials
Page 1 / 8

Organizations

Research & Development (97)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
Eli LillyFor profit705652010
IncyteFor profit21142009
Assistance Publique - Hôpitaux de ParisAcademic/Hospital5532021
Bangladesh Medical UniversityAcademic/Hospital5432021
Emory UniversityAcademic/Hospital5412023
Chinese Academy of Medical SciencesAcademic/Hospital4422020
Peking UniversityAcademic/Hospital4412022
People's Liberation Army of ChinaGovernment4212023
Capital Medical UniversityAcademic/Hospital3022023
National Institute of Allergy and Infectious Diseases (NIAID)Government3322020
National Institute of Mental Health (NIMH)Government3012023
Tianjin Medical UniversityAcademic/Hospital3212023
Azienda USL 4 PratoAcademic/Hospital2212020
Fujian Medical UniversityAcademic/Hospital2112024
Government of ChinaGovernment2012023
Government of FranceGovernment2122021
Huazhong University of Science and TechnologyAcademic/Hospital2122022
Mayo ClinicAcademic/Hospital2212017
National Cancer Institute (NCI)Government2112016
National Institutes of Health (NIH)Government2022023
97 organizations
Page 1 / 5

Marketing (4)

OrganizationOrg typeRelationshipDate
Aurobindo PharmaFor profitMKTGJul 22, 2024
Eli LillyFor profitNDA2May 31, 2018
Eli LillyFor profitNDAMay 31, 2018
MSN LaboratoriesFor profitMKTGAug 8, 2025