Baricitinib in COVID-19

Artificial intelligence technology raised a hypothesis that prompted interest in studying baricitinib for COVID-19. The hypothesis of a host antiviral mechanism in addition to baricitinib’s known anti-inflammatory properties triggered Lilly and the global scientific community to collaborate on lab experiments to validate the hypothesis. Baricitinib’s anti-inflammatory properties were already well-characterized based on research from other conditions. Lilly is committed to understanding baricitinib’s potential use for COVID-19, which included performing nonclinical studies to evaluate its potential host antiviral effects.

Lilly entered into an agreement with the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), to study baricitinib in NIAID’s Adaptive COVID-19 Treatment Trial, ACTT-2. This arm of the randomized, double-blind, placebo-controlled clinical trial began in May 2020 to evaluate the safety and efficacy of a treatment regimen of the investigational antiviral remdesivir plus baricitinib vs. remdesivir plus placebo in hospitalized patients with moderate to severe disease including those on mechanical ventilation.

Lilly also initiated a Phase 3 randomized, double-blind, placebo-controlled study in June 2020 to evaluate the efficacy and safety of baricitinib vs. placebo in hospitalized adults with COVID-19. The study – conducted in the United States, Europe, Latin America and Japan – includes patients hospitalized with COVID-19 infection who have at least one elevated marker of inflammation and evidence of pneumonia or other symptoms but do not require invasive mechanical ventilation at study entry. In parallel, Lilly is collaborating with academic and government institutions who are exploring the efficacy and safety of baricitinib.

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In September 2020, Lilly and Incyte announced initial data emerging from the Adaptive COVID-19 Treatment Trial (ACTT-2) sponsored by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH). Baricitinib in combination with remdesivir met the primary endpoint of reduction of time to recovery in comparison with remdesivir. The study also met a key secondary endpoint.

In June 2020, data was published in EMBO Molecular Medicine highlighting baricitinib’s potential as a COVID-19 treatment. Case reports and retrospective data related to the use of baricitinib in patients with COVID-19 from Europe and the U.S. also has been published. Collectively, the data supports the evaluation of baricitinib in patients with progressing disease in randomized clinical trials.

It is important to note that baricitinib is being investigated to learn whether it may be beneficial in COVID-19 infection. Baricitinib is a JAK1/JAK2 inhibitor approved in more than 70 countries for the treatment of adults with moderately to severely active rheumatoid arthritis (RA). The labels for the approved RA indication includes a warning and precaution to avoid use in patients with active, serious infection and to interrupt therapy until the infection is controlled if a serious infection develops. This is part of a Boxed Warning; see here for full safety information.

Disclaimer About Baricitinib in COVID-19

This contains forward-looking statements (as that term is defined in the Private Securities Litigation Reform Act of 1995) about baricitinib as a potential treatment for patients with COVID-19 and reflects Lilly’s current beliefs. However, as with any pharmaceutical product, there are substantial risks and uncertainties in the process of development and commercialization. Among other things, there can be no guarantee that baricitinib will prove to be an effective treatment for COVID-19 or receive additional regulatory approvals. For further discussion of these and other risks and uncertainties, see Lilly’s most recent Form 10-K and Form 10-Q filings with the United States Securities and Exchange Commission. Except as required by law, Lilly undertakes no duty to update forward-looking statements to reflect events after the date of this release.

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