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Last Updated: March 14, 2025

CLINICAL TRIALS PROFILE FOR BARICITINIB


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505(b)(2) Clinical Trials for BARICITINIB

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials
Trial TypeTrial IDTitleStatusSponsorPhaseStart DateSummary
New Dosage NCT05187793 ↗ Randomized Study of Efficacy of Different Treatment Regimens of Olokizumab Recruiting Federal Budget Institution of Science "Central Research Institute of Epidemiology" of the Rospotrebnadzor Phase 3 2021-07-08 The primary objective of the study is to evaluate the efficacy and safety of Artlegia (INN: olokizumab) new dosing regimen in patients with moderate coronavirus infection (COVID-19) with signs of hyperinflammation. This study is a multicentre, open-label, randomized, comparative, parallel group, active-controlled clinical trial.
New Dosage NCT05187793 ↗ Randomized Study of Efficacy of Different Treatment Regimens of Olokizumab Recruiting Group of companies Medsi, JSС Phase 3 2021-07-08 The primary objective of the study is to evaluate the efficacy and safety of Artlegia (INN: olokizumab) new dosing regimen in patients with moderate coronavirus infection (COVID-19) with signs of hyperinflammation. This study is a multicentre, open-label, randomized, comparative, parallel group, active-controlled clinical trial.
New Dosage NCT05187793 ↗ Randomized Study of Efficacy of Different Treatment Regimens of Olokizumab Recruiting R-Pharm Phase 3 2021-07-08 The primary objective of the study is to evaluate the efficacy and safety of Artlegia (INN: olokizumab) new dosing regimen in patients with moderate coronavirus infection (COVID-19) with signs of hyperinflammation. This study is a multicentre, open-label, randomized, comparative, parallel group, active-controlled clinical trial.
>Trial Type>Trial ID>Title>Status>Phase>Start Date>Summary
Showing 1 to 3 of 3 entries

All Clinical Trials for BARICITINIB

Trial IDTitleStatusSponsorPhaseStart DateSummary
NCT01185353 ↗ A Study in Participants With Rheumatoid Arthritis on Background Methotrexate Therapy Completed Incyte Corporation Phase 2 2010-10-01 The purpose of this trial is to evaluate the safety and efficacy of LY3009104 in participants with Rheumatoid Arthritis (RA).
NCT01185353 ↗ A Study in Participants With Rheumatoid Arthritis on Background Methotrexate Therapy Completed Eli Lilly and Company Phase 2 2010-10-01 The purpose of this trial is to evaluate the safety and efficacy of LY3009104 in participants with Rheumatoid Arthritis (RA).
NCT00902486 ↗ INCB028050 Compared to Background Therapy in Patients With Active Rheumatoid Arthritis (RA) With Inadequate Response to Disease Modifying Anti-Rheumatic Drugs Completed Incyte Corporation Phase 2 2009-05-01 This was a randomized, double blind, placebo controlled, dose ranging, parallel group study. Participants who had active rheumatoid arthritis (RA) who had inadequate response to any disease modifying anti-rheumatic drug (DMARD) therapy including biologics were enrolled. Screening evaluations were performed within approximately 28 days of randomization. The duration of the study was 6 months with the primary endpoint assessed at 3 months. Eligible participants were randomly assigned to one of three doses (4, 7 or 10 mg QD) of INCB028050 (Baricitinib) or placebo.
>Trial ID>Title>Status>Phase>Start Date>Summary
Showing 1 to 3 of 3 entries

Clinical Trial Conditions for BARICITINIB

Condition Name

191210002468101214161820Rheumatoid ArthritisHealthy VolunteersAtopic Dermatitis[disabled in preview]
Condition Name for BARICITINIB
Intervention Trials
Rheumatoid Arthritis 19
Healthy Volunteers 12
Atopic Dermatitis 10
[disabled in preview] 0
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Condition MeSH

24212000510152025ArthritisArthritis, RheumatoidCOVID-19[disabled in preview]
Condition MeSH for BARICITINIB
Intervention Trials
Arthritis 24
Arthritis, Rheumatoid 21
COVID-19 20
[disabled in preview] 0
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Clinical Trial Locations for BARICITINIB

Trials by Country

+
Trials by Country for BARICITINIB
Location Trials
United States 553
Japan 154
Germany 91
United Kingdom 87
India 67
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Trials by US State

+
Trials by US State for BARICITINIB
Location Trials
Florida 28
California 26
Texas 25
New York 25
Pennsylvania 24
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Clinical Trial Progress for BARICITINIB

Clinical Trial Phase

16.4%69.1%14.5%00510152025303540Phase 4Phase 3Phase 2/Phase 3[disabled in preview]
Clinical Trial Phase for BARICITINIB
Clinical Trial Phase Trials
Phase 4 9
Phase 3 38
Phase 2/Phase 3 8
[disabled in preview] 0
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Clinical Trial Status

37.5%34.6%27.9%00510152025303540CompletedRecruitingNot yet recruiting[disabled in preview]
Clinical Trial Status for BARICITINIB
Clinical Trial Phase Trials
Completed 39
Recruiting 36
Not yet recruiting 29
[disabled in preview] 0
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Clinical Trial Sponsors for BARICITINIB

Sponsor Name

trials0102030405060Eli Lilly and CompanyIncyte CorporationBangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh[disabled in preview]
Sponsor Name for BARICITINIB
Sponsor Trials
Eli Lilly and Company 63
Incyte Corporation 20
Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh 3
[disabled in preview] 0
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Sponsor Type

51.0%45.7%0-100102030405060708090100110OtherIndustryNIH[disabled in preview]
Sponsor Type for BARICITINIB
Sponsor Trials
Other 106
Industry 95
NIH 7
[disabled in preview] 0
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Baricitinib: Clinical Trials, Market Analysis, and Projections

Introduction to Baricitinib

Baricitinib, a Janus kinase (JAK) inhibitor, has garnered significant attention in recent years for its versatility in treating various autoimmune and inflammatory conditions. Initially developed to treat rheumatoid arthritis, baricitinib has expanded its therapeutic scope to include severe COVID-19 and other autoimmune diseases.

Clinical Trials and Efficacy

ACTT Trials and FDA Approval

Baricitinib's efficacy in treating COVID-19 was notably demonstrated in the Adaptive COVID-19 Treatment Trial (ACTT-2) conducted by Stanford's division of Hospital Medicine. This trial showed that baricitinib, when combined with remdesivir, was effective in treating moderate to severe COVID-19 patients. The results led to the FDA's emergency use approval for baricitinib in treating COVID-19 patients[1].

TACTIC-R Trial

In contrast, the TACTIC-R trial, a phase 4 randomised trial conducted in the UK, did not show significant efficacy of baricitinib in reducing disease severity in patients with severe COVID-19. However, this trial had limitations, including a short dosing period and relatively small numbers, which might explain the discrepancy with other trials like RECOVERY and ACTT-2[4].

Ongoing and Future Trials

The adaptive trial approach continues, with trials like ACTT-3 and ACTT-4 exploring other therapeutic agents and combinations. For instance, ACTT-4 will compare baricitinib with dexamethasone, further expanding the understanding of baricitinib's efficacy in different contexts[1].

Mechanism of Action

Baricitinib works by inhibiting the activity of JAK1 and JAK2 enzymes, which are crucial in the signaling pathways leading to inflammation and immune responses. By blocking these enzymes, baricitinib reduces the inflammatory response, making it effective in treating autoimmune conditions and potentially severe viral infections[2].

Market Analysis

Global Market Size and Projections

The global baricitinib market is experiencing rapid growth. By 2026, the market is projected to reach approximately $4.2 billion, growing at a compound annual growth rate (CAGR) of around 15%[2]. More long-term projections indicate that the market could reach $17.48 billion by 2031, with a CAGR of 17% from 2024 to 2031[3].

Key Drivers of Growth

Several factors are driving this growth:

  • Expanding Indications: Baricitinib's applications have extended beyond rheumatoid arthritis to include conditions like atopic dermatitis, psoriatic arthritis, and severe COVID-19[3].
  • Increasing Demand: Rising incidences of autoimmune diseases and the ongoing need for effective treatments for COVID-19 are driving global demand[2].
  • Innovations in Formulation and Delivery: New formulations and delivery methods are enhancing the drug's efficacy and patient compliance[2].

Market Segmentation

The baricitinib market can be segmented by indication (rheumatoid arthritis, atopic dermatitis, psoriatic arthritis, COVID-19), route of administration (oral, intravenous), end user (hospitals, clinics, homecare), and distribution channel (retail pharmacies, hospital pharmacies, online pharmacies)[5].

Investment Opportunities

Research and Development

Investing in ongoing research and development is crucial, as it explores new therapeutic indications and optimizes treatment outcomes. Strategic partnerships and collaborations can also enhance the safety and efficacy of baricitinib[3].

Expanding Therapeutic Applications

The expanding range of applications for baricitinib creates new revenue streams. Investors are attracted by the drug’s proven efficacy and the broadening therapeutic landscape[2].

Innovations in Drug Formulation

Innovations in drug formulation and administration are enhancing patient compliance and therapeutic outcomes. These advancements are contributing to the drug’s growing popularity and acceptance in the medical community[2].

Recent Innovations

New Formulations and Delivery Methods

Recent developments include new formulations of baricitinib that offer improved dosing schedules and enhanced bioavailability. Combination therapies that incorporate baricitinib with other agents are also being explored to optimize treatment outcomes[2].

Personalized Medicine

The trend towards personalized medicine and targeted therapies is supporting the growth of the baricitinib market. These approaches provide individualized therapy options for autoimmune illnesses, further increasing the market's appeal[3].

Quotes from Industry Experts

"We need to aggressively continue with our clinical trials until we have an effective vaccine or a definitive treatment, and hopefully both." - Ahuja, highlighting the ongoing need for rigorous clinical trials[1].

Illustrative Statistics

  • Market Size: The global baricitinib market is projected to reach $4.2 billion by 2026, growing at a CAGR of around 15%[2].
  • Long-term Growth: By 2031, the market is expected to reach $17.48 billion, with a CAGR of 17% from 2024 to 2031[3].
  • Clinical Trial Participation: The ACTT-2 trial involved 1033 participants, while the RECOVERY trial had 8156 participants, showcasing the scale of clinical research[4].

Key Takeaways

  • Clinical Trials: Baricitinib has shown efficacy in treating COVID-19 in trials like ACTT-2, but results vary across different studies.
  • Market Growth: The global baricitinib market is projected to grow significantly, driven by expanding indications and increasing demand.
  • Innovations: New formulations and delivery methods, along with personalized medicine approaches, are enhancing the drug's efficacy and market appeal.
  • Investment Opportunities: Research and development, expanding therapeutic applications, and strategic partnerships offer significant growth potential.

FAQs

What is baricitinib primarily used for?

Baricitinib is primarily used to treat rheumatoid arthritis by inhibiting specific enzymes involved in inflammation. It has also been used in managing severe COVID-19 and is being explored for other autoimmune diseases[2].

How does baricitinib work?

Baricitinib works by inhibiting the activity of JAK1 and JAK2 enzymes, which are critical in the signaling pathways leading to inflammation and immune responses[2].

What are the key drivers of the baricitinib market growth?

The key drivers include expanding indications, increasing demand for autoimmune disease treatments, and innovations in drug formulation and delivery[2].

What are the projected market sizes for baricitinib?

By 2026, the market is projected to reach $4.2 billion, and by 2031, it is expected to reach $17.48 billion[2][3].

What are the ongoing clinical trials for baricitinib?

Trials like ACTT-3 and ACTT-4 are ongoing, with ACTT-4 comparing baricitinib with dexamethasone. Other trials are exploring its effectiveness in additional autoimmune diseases[1].

Sources

  1. Stanford Medicine: "After Clinical Trial, Baricitinib Approved for Emergency Use"[1]
  2. Market Research Intellect: "Baricitinib Market Size And Projection"[2]
  3. Market Research Intellect: "Baricitinib Market Size and Projections"[3]
  4. The Lancet: "Efficacy and safety of baricitinib or ravulizumab in adult patients with severe COVID-19"[4]
  5. Market Research Future: "Baricitinib Market Size, Growth Report 2032"[5]

More… ↓

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