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.

Baricitinib was first approved by the European Commission (EC) in February 2017 for the treatment of rheumatoid arthritis in adults and was later approved by the FDA in 2018. The EC later approved baricitinib for the treatment of atopic dermatitis, making it the first JAK inhibitor used for this indication in Europe. While baricitinib was granted emergency use as a treatment for COVID-19 in combination with remdesivir under the Emergency Use Authorization (EUA) in November 2020, the FDA fully approved the use of baricitinib for the treatment of COVID-19 in May 2022.

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.

In Europe, baricitinib is indicated for the treatment of moderate to severe atopic dermatitis in adult patients who are candidates for systemic therapy.

In the US, baricitinib is also indicated for the treatment of coronavirus disease 2019 (COVID-19) in hospitalized adults requiring supplemental oxygen, non-invasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation. Recently, it is also approved as the treatment for severe alopecia areata in adults.

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 to Measure Baricitinib (LY3009104) Absorption in Healthy Participants

Phase 1

Completed

Conditions: Healthy Volunteers

Interventions: Drug: Baricitinib
Drug: [^13C4D3^15N]-baricitinib

First Posted Date: 2015-01-16

Last Posted Date: 2017-06-01

Lead Sponsor: Eli Lilly and Company

Target Recruit Count: 8

Registration Number: NCT02340104

Locations: 🇬🇧
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY, Leeds, Yorkshire, United Kingdom

A Study of Baricitinib (LY3009104) in Participants With Rheumatoid Arthritis (RA)

Phase 3

Completed

Conditions: Rheumatoid Arthritis

Interventions: Drug: Placebo
Drug: Baricitinib

First Posted Date: 2014-10-16

Last Posted Date: 2019-09-11

Lead Sponsor: Eli Lilly and Company

Target Recruit Count: 290

Registration Number: NCT02265705

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., ZhuZhou, China

A Study of Baricitinib in Healthy Japanese Participants

Phase 1

Completed

Conditions: Healthy Participants

Interventions: Drug: Baricitinib

First Posted Date: 2014-10-13

Last Posted Date: 2017-06-06

Lead Sponsor: Eli Lilly and Company

Target Recruit Count: 16

Registration Number: NCT02263911

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., Hachioji, Tokyo, Japan

A Study of Baricitinib and Ciclosporin in Healthy Participants

Phase 1

Completed

Conditions: Healthy Volunteers

Interventions: Drug: Baricitinib
Drug: Ciclosporin

First Posted Date: 2013-10-23

Last Posted Date: 2017-06-06

Lead Sponsor: Eli Lilly and Company

Target Recruit Count: 18

Registration Number: NCT01968057

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 Simvastatin in Healthy Participants

Phase 1

Completed

Conditions: Healthy Volunteers

Interventions: Drug: Simvastatin
Drug: Baricitinib

First Posted Date: 2013-10-10

Last Posted Date: 2017-06-06

Lead Sponsor: Eli Lilly and Company

Target Recruit Count: 40

Registration Number: NCT01960140

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 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

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