Baricitinib

Generic Name: Baricitinib

Brand Names: Olumiant

Drug Type: Small Molecule

Chemical Formula: C_₁₆H_₁₇N_₇O_₂S

CAS Number: 1187594-09-7

Unique Ingredient Identifier: ISP4442I3Y

Background: Baricitinib is a Janus kinase (JAK) inhibitor. JAKs are tyrosine protein kinases that play an important role in pro-inflammatory signaling pathways. Overactive JAKs have been implicated in autoimmune disorders, such as rheumatoid arthritis. By inhibiting the actions of JAK1 and JAK2, baricitinib attenuates JAK-mediated inflammation and immune responses.
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Indication: In the US and Europe, baricitinib is indicated for the treatment of adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response to one or more TNF blockers. Baricitinib may be used as monotherapy or in combination with methotrexate or other DMARDs.
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Associated Conditions: Alopecia Areata (AA), Coronavirus Disease 2019 (COVID‑19), Severe Atopic Dermatitis, Moderate Atopic dermatitis, Moderate, active Rheumatoid arthritis, Severe, active Rheumatoid arthritis

Associated Therapies: -

Clinical Trials

A Study of Baricitinib and Probenecid in Healthy Participants

Phase 1

Completed

Conditions: Healthy Volunteers

Interventions: Drug: Baricitinib
Drug: Probenecid

First Posted Date: 2013-09-09

Last Posted Date: 2017-06-06

Lead Sponsor: Eli Lilly and Company

Target Recruit Count: 18

Registration Number: NCT01937026

Locations: 🇬🇧
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Leeds, West Yorkshire, United Kingdom

A Study of Baricitinib and Omeprazole in Healthy Participants

Phase 1

Completed

Conditions: Healthy Volunteers

Interventions: Drug: Baricitinib
Drug: Omeprazole

First Posted Date: 2013-08-19

Last Posted Date: 2017-06-06

Lead Sponsor: Eli Lilly and Company

Target Recruit Count: 30

Registration Number: NCT01925144

Locations: 🇬🇧
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Leeds, West Yorkshire, United Kingdom

A Study of Baricitinib When Administered With Ketoconazole or Fluconazole in Healthy Participants

Phase 1

Completed

Conditions: Healthy Volunteers

Interventions: Drug: Baricitinib
Drug: Ketoconazole
Drug: Fluconazole

First Posted Date: 2013-08-16

Last Posted Date: 2017-06-06

Lead Sponsor: Eli Lilly and Company

Target Recruit Count: 36

Registration Number: NCT01924299

Locations: 🇬🇧
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Leeds, West Yorkshire, United Kingdom

A Study of Baricitinib and Rifampicin in Healthy Participants

Phase 1

Completed

Conditions: Healthy Volunteers

Interventions: Drug: Baricitinib
Drug: Rifampicin

First Posted Date: 2013-07-29

Last Posted Date: 2017-06-06

Lead Sponsor: Eli Lilly and Company

Target Recruit Count: 18

Registration Number: NCT01910311

Locations: 🇬🇧
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Leeds, West Yorkshire, United Kingdom

A Study of Baricitinib and Birth Control Pills in Healthy Females

Phase 1

Completed

Conditions: Healthy Volunteers

Interventions: Drug: Baricitinib
Drug: Microgynon

First Posted Date: 2013-07-11

Last Posted Date: 2017-06-06

Lead Sponsor: Eli Lilly and Company

Target Recruit Count: 20

Registration Number: NCT01896726

Locations: 🇬🇧
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Leeds, West Yorkshire, United Kingdom

An Extension Study in Participants With Moderate to Severe Rheumatoid Arthritis

Phase 3

Completed

Conditions: Rheumatoid Arthritis

Interventions: Drug: Baricitinib
Drug: Placebo

First Posted Date: 2013-06-24

Last Posted Date: 2022-04-25

Lead Sponsor: Eli Lilly and Company

Target Recruit Count: 2877

Registration Number: NCT01885078

Locations: 🇬🇷
Hippokration Hospital of Athens, Athens, Attiki, Greece
🇬🇷
University General Hospital of Larissa, Larissa, Greece
🇺🇸
Diagnostic Rheumatology and Research, Indianapolis, Indiana, United States

and more 404 locations

A Pharmacokinetic Study of Baricitinib in Participants With Liver Disease

Phase 1

Completed

Conditions: Hepatic Insufficiency
Liver Diseases

Interventions: Drug: Baricitinib

First Posted Date: 2013-06-06

Last Posted Date: 2017-06-06

Lead Sponsor: Eli Lilly and Company

Target Recruit Count: 16

Registration Number: NCT01870388

Locations: 🇺🇸
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Orlando, Florida, United States

A Drug Drug Interaction (DDI) Study of Baricitinib (LY3009104) and Digoxin in Healthy Participants

Phase 1

Completed

Conditions: Healthy Volunteers

Interventions: Drug: Baricitinib
Drug: Digoxin

First Posted Date: 2013-05-21

Last Posted Date: 2017-06-06

Lead Sponsor: Eli Lilly and Company

Target Recruit Count: 28

Registration Number: NCT01859078

Locations: 🇬🇧
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Leeds, West Yorkshire, United Kingdom

Compassionate Use Protocol for the Treatment of Autoinflammatory Syndromes

Conditions: Juvenile Dermatomyositis (JDM)
Chronic Atypical Neutrophilic Dermatosis With Lipodystrophy and Elevated Temperature (CANDLE)
Stimulator of Interferon Genes (STING)-Associated Vasculopathy With Onset During Infancy (SAVI)
Aicardi-Goutières Syndrome (AGS)

First Posted Date: 2012-11-12

Last Posted Date: 2023-10-23

Lead Sponsor: Eli Lilly and Company

Registration Number: NCT01724580

Locations: 🇺🇸
Translational Autoinflammatory Disease (TADS), Bethesda, Maryland, United States
🇺🇸
Children's Hospital of Philadelphia, Philadelphia, Pennsylvania, United States
🇬🇧
Great Ormond Street Hospital, London, United Kingdom

A Study in Moderate to Severe Rheumatoid Arthritis Participants

Phase 3

Completed

Conditions: Rheumatoid Arthritis

Interventions: Drug: Placebo
Drug: Baricitinib
Drug: cDMARD

First Posted Date: 2012-11-02

Last Posted Date: 2019-09-18

Lead Sponsor: Eli Lilly and Company

Target Recruit Count: 684

Registration Number: NCT01721057

Locations: 🇬🇧
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., North Shields, Tyneside, United Kingdom

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