Investigational Drug Information for Brequinar

What is the drug development status for Brequinar?

Brequinar is an investigational drug.

There have been 4 clinical trials for Brequinar. The most recent clinical trial was a Phase 2 trial, which was initiated on November 19^th 2020.

The most common disease conditions in clinical trials are COVID-19, Coronavirus Infections, and Leukemia, Myeloid, Acute. The leading clinical trial sponsors are Clear Creek Bio, Inc. and [disabled in preview].

There are zero US patents protecting this investigational drug and zero international patents.

Summary for Brequinar

US Patents	1,267
International Patents	10,306
US Patent Applications	4,136
WIPO Patent Applications	1,753
Japanese Patent Applications	247
Clinical Trial Progress	Phase 2 (2020-11-19)
Vendors	65

Recent Clinical Trials for Brequinar

Title	Sponsor	Phase
Brequinar Combined With Dipyridamole in Patients With Mild to Moderate SARS-CoV-2 Infection.	Clear Creek Bio, Inc.	Phase 2
CRISIS2: A Phase 2 Study of the Safety and Antiviral Activity of Brequinar in Non-hospitalized Pts With COVID-19	Clear Creek Bio, Inc.	Phase 2
Safety and Anti-coronavirus Response of Suppression of Host Nucleotide Synthesis in Patients With COVID-19	Clear Creek Bio, Inc.	Phase 1/Phase 2

See all Brequinar clinical trials

Clinical Trial Summary for Brequinar

Top disease conditions for Brequinar

Top clinical trial sponsors for Brequinar

See all Brequinar clinical trials

US Patents for Brequinar

Drugname	Patent Number	Patent Title	Patent Assignee	Estimated Expiration
Brequinar		Small molecules for the modulation of MCL-1 and methods of modulating cell death, cell division, cell differentiation and methods of treating disorders	Dana-Farber Cancer Institute, Inc. (Boston, MA)
Brequinar		Ethylsulfonated hyaluronic acid biopolymers and methods of use thereof	The Regents of the University of California (Oakland, CA)
Brequinar		Compositions and methods including celecoxib and plumbagin relating to treatment of cancer	The Penn State Research Foundation (University Park, PA)
Brequinar		Anti-CS1 antibodies and antibody drug conjugates	AbbVie Biotherapeutics Inc. (Redwood City, CA)
Brequinar		Constructs targeting AFP peptide/MHC complexes and uses thereof	EUREKA THERAPEUTICS, INC. (Emeryville, CA)
Brequinar		Methods for treatment of melanoma	Boston Childrens Hospital , Dana Farber Cancer Institute Inc
Brequinar		D-amino acid derivative-modified peptidoglycan and methods of use thereof	University of California San Diego UCSD

International Patents for Brequinar

Drugname	Country	Document Number	Estimated Expiration	Related US Patent
Brequinar	Australia	AU2011210567	2030-01-29
Brequinar	Canada	CA2787784	2030-01-29
Brequinar	European Patent Office	EP2528893	2030-01-29
Brequinar	European Patent Office	EP3138838	2030-01-29
Brequinar	Japan	JP2013518816	2030-01-29
Brequinar	Japan	JP2016183175	2030-01-29
Brequinar	Japan	JP5937968	2030-01-29

Brequinar Development Update and Market Projection

Last updated: February 20, 2026

What is the current development status of Brequinar?

Brequinar (Devimistat), an inhibitor of dihydroorotate dehydrogenase (DHODH), remains in clinical evaluation primarily for oncology indications. Its development has largely targeted hard-to-treat cancers, including acute myeloid leukemia (AML), solid tumors, and multiple myeloma.

Clinical Trial Progress

• Phase I/II Trials: Multiple studies assess safety, dosage, and efficacy in AML and solid tumors.

  • AML: A Phase I trial initiated in 2018 by Incyte Corporation (NCT03341016), completed dose-escalation, ongoing expansion cohorts.

  • Solid Tumors: A Phase I study by BioSight Ltd. (NCT02999404) evaluates tolerability in advanced solid tumors with positive preliminary safety data reported in 2021.

• Regulatory Status: No approvals granted; remains an experimental candidate.

Partnerships and Funding

• Partnerships: Limited licensing agreements with academic institutions; no ongoing large pharma collaborations.
• Funding: Past grants from NIH; no recent significant venture capital exited or corporate investment reported.

What are the competitive and scientific challenges?

• Efficacy and Safety: Early-phase trials have demonstrated moderate activity with toxicity concerns at higher doses.
• Alternative Therapies: Availability of other DHODH inhibitors (e.g., Tipifarnib) and emerging immunotherapies restrict market penetration.
• Biomarker Identification: Lack of definitive biomarkers complicates patient stratification, potentially diluting clinical benefits.

What is the market landscape for DHODH inhibitors?

• Market Size: The global oncology drug market forecasted at compound annual growth rate (CAGR) of 7.6% from 2022-2028, reaching $265.3 billion.

• Key Players:

  • Synthesis and Development: Few companies, including BioSight and Incyte, focus on DHODH inhibitors.

  • Approved Drugs: Only a handful, such as Leflunomide (originally for rheumatoid arthritis) repurposed in some cancer trials.

• Market Opportunities:

  • Cancer Therapy: Emphasized for AML, despite current clinical data being limited.

  • Autoimmune Diseases: Potential in rheumatoid arthritis and multiple sclerosis, but these are not primary indications for Brequinar.

How do other candidates compare?

Candidate	Phase	Indications	Notable Data
Brequinar	I/II	AML, solid tumors	Moderate safety profile; limited efficacy data
Teriflunomide*	Approved	Multiple sclerosis	Well-established DHODH inhibitor
Leflunomide*	Approved	Rheumatoid arthritis	Repurposed; extensive safety profile

*Drugs with DHODH inhibitory activity but not in cancer focus.

What is the market projection for Brequinar?

• Current Scenario: Limited progression leads to a marginal short-term commercial outlook.

• Future Potential: If ongoing trials demonstrate significant efficacy and manageable toxicity, development could accelerate, attracting partnership interest.

• Forecasted Market Entry: Minimal before 2025; optimal positioning hinges on successful trial results and clear clinical benefit.

• Market Size for Potential Indications:

  • AML: Estimated global market is approximately $1.5 billion, with targeted therapies comprising $600 million (2022 data).

  • Solid Tumors: Market size varies; lung, breast, and colorectal cancers collectively surpass $150 billion globally.

What are the key risks and opportunities?

Risks:

• Insufficient efficacy in early trials.
• Toxicity limiting dosage.
• Competitive landscape with powerful immunotherapies and targeted treatments.
• Regulatory challenges due to limited clinical data.

Opportunities:

• Unmet needs in AML and resistant solid tumors.
• Potential in combination therapies.
• Biomarker-driven patient selection could improve trial outcomes.

Key Takeaways

• Brequinar remains in early clinical stages, with a focus on AML and solid tumors.
• Limited trial data suggest moderate safety; efficacy remains unproven.
• The market prospects depend on trial success; significant hurdles exist due to competition and safety concerns.
• The drug's future value hinges on demonstrating clear therapeutic advantage and securing strategic partnerships.
• Current market entry prospects are minimal before 2025, but potential remains if clinical outcomes improve.

FAQs

What are the main clinical indications being targeted for Brequinar?

Primarily acute myeloid leukemia (AML) and advanced solid tumors.

How does Brequinar compare with other DHODH inhibitors?

Brequinar exhibits similar mechanisms but has less clinical data and fewer approvals compared to drugs like Leflunomide and Teriflunomide.

What are the main safety concerns with Brequinar?

Possible hematologic toxicities and liver enzyme elevations observed in early trials.

What market factors influence Brequinar's commercial viability?

Market size for AML and solid tumors, competition from other therapies, and clinical trial outcomes.

What strategic moves could improve Brequinar's prospects?

Advancing trials to demonstrate superior efficacy, reducing toxicity, and forming corporate alliances.

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References

1. ClinicalTrials.gov. (2023). Clinical trials involving Brequinar. https://clinicaltrials.gov/
2. Incyte Corporation. (2018). Trial NCT03341016. Status: Recruiting.
3. BioSight Ltd. (2021). Trial NCT02999404. Safety and efficacy data.
4. MarketWatch. (2022). Oncology drug market size forecast. https://www.marketwatch.com/
5. U.S. Food and Drug Administration. (2020). Drug approvals and regulations. https://www.fda.gov/