Vumerity

(Diroximel fumarate)

Phase 3Small molecule

Biogen

Vumerity is one of 80 small molecule programs targeting Schizophrenia. It is currently in Phase 3.

Indications

Total Trials

Active Trials

Competitors

FDA Application

NDA/BLA/ANDA regulatory filings

Patents

Pipeline

Status by Indication[3][1]

Indication

SchizophreniaActive, not recruiting

Peripheral Artery DiseaseRecruiting

Multiple SclerosisNot yet recruiting

SchizophreniaPreclinical

Active, not recruiting

Peripheral Artery DiseasePhase 1

Recruiting

Multiple SclerosisPhase 3

Not yet recruiting

Competition

Competitive Landscape

174 competitors in Schizophrenia

#DrugCompanyPhaseTrials

Vumerity

Biogen

Phase 3

1 2

Ozempic

Novo Nordisk

Preclinical

1 3

Resotran

Takeda

Preclinical

1 4

Inapsine

Jazz Pharmaceuticals

Preclinical

1 5

Depakote

Ibrance

Lunesta

3 8

Luvox

SSolvay Pharmaceuticals

Preclinical

1 9

Catapres

Boehringer Ingelheim

Preclinical

1 10

Rapamune

PPrism Pharmaceuticals

Preclinical

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q4 2026

Active, not recruiting

Multiple Sclerosis (MS) - Relapsing-Remitting

NCT07757568

Phase 1Recruiting

Peripheral Artery Disease

NCT06319339

Q1 2027

N/ARecruiting

Schizophrenia

NCT06957808

Q1 2031

Recruiting

Pregnancy

NCT05688436

Q3 2032

Recruiting

Multiple Sclerosis

NCT05658497

Clinical

Trials by Indication[1]

Multiple Sclerosis4 trials

A Study to Learn About the Safety of Diroximel Fumarate (DRF) and Dimethyl Fumarate (DMF) and Their Effects on Relapses in Pediatric Participants With Relapsing Forms of Multiple Sclerosis (RMS)

Not yet recruiting· Biogen logo

Biogen·Phase 3·NCT07483632·185 enrolled

A Study of Diroximel Fumarate (DRF) in Adult Participants From the Asia-Pacific Region With Relapsing Forms of Multiple Sclerosis (RMS)

Completed· Biogen logo

Biogen·Phase 3·NCT05083923·136 enrolled

A Study to Evaluate Long-Term Safety of Vumerity and Tecfidera in Participants With Multiple Sclerosis (MS)

Active, not recruiting· Biogen logo

Biogen··NCT05767736·10,500 enrolled

Show 1 more trial

Vumerity (Diroximel Fumarate) Prospective MS Pregnancy Exposure Registry

Recruiting· Biogen logo

Biogen··NCT05658497·908 enrolled

Oral1 trial

Relationship Between Oral DMT Burden and Adherence in MS

Enrolling by invitation·MMonash University··NCT04676204·323 enrolled

Schizophrenia1 trial

Investigating the Effect of Diroximel Fumarate on Glutathione in Schizophrenia

Recruiting·KKing's College London·N/A·NCT06957808·30 enrolled

Pregnancy1 trial

A Study to Learn More About The Safety of Diroximel Fumarate (VUMERITY®) in Participants Who Took it During Pregnancy And About the Health of Their Babies

Recruiting· Biogen logo

Biogen··NCT05688436·1,178 enrolled

Adult1 trial

A Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Diroximel Fumarate (DRF) in Chinese and Caucasian Adult Healthy Participants

Completed· Biogen logo

Biogen·Phase 1·NCT05127564·32 enrolled

3 more indications

Multiple Sclerosis (MS) - Relapsing-remitting1 trial

Prospective Evaluation of De-Escalation From antiCD-20 Therapies to Dimethyl Fumarate (Tecfidera) or Diroximel Fumarate (Vumerity)

Active, not recruiting·UUniversity of Colorado, Denver··NCT07757568·11 enrolled

Peripheral Artery Disease1 trial

Impact of Nrf2 Activation on Macrovascular Function, Microvascular Function, Leg Function, and Walking Capacity in Patients With Peripheral Artery Disease

Recruiting·UUniversity of Nebraska·Phase 1·NCT06319339·20 enrolled

Unspecified3 trials

Study of Diroximel Fumarate in the Real-World Setting

Terminated· Biogen logo

Biogen··NCT04746976·75 enrolled

Exploring Diroximel Fumarate Real-world Experience in Canada and Israel

Terminated· Biogen logo

Biogen··NCT04948606·64 enrolled

Bioequivalence Study of Bafiertam 190 mg and Vumerity® 462 mg Delayed-Release Capsules in Fasting Healthy Subjects

Completed·BBanner Life Sciences LLC·Phase 1·NCT05181215·46 enrolled

Regulatory

FDA Approval Timeline[4]

Oct 29, 2019

VUMERITY

NDA NDA211855

Sources

References

[1]
ClinicalTrials.gov — 13 trial records for Diroximel fumarate. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Diroximel fumarate compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Diroximel fumarate. EMBL-EBI & Wellcome Sanger Institute.
[4]
OpenFDA — FDA approval records (NDA NDA211855). U.S. Food & Drug Administration.
[5]
FDA Orange Book — Patent and exclusivity data for Vumerity. U.S. Food & Drug Administration.
[6]
SEC EDGAR — Biogen company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Highest Phase: Phase 3[1]
Company: Biogen

Patent Landscape[5]

Patent Cliff

Sep 20, 2033

Earliest patent expiration — generic entry possible after this date

Patent #Expires

9090558Sep 20, 2033

10080733Sep 20, 2033

8669281Oct 29, 2033

Vumerity

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q4 2026

Q1 2027

Q1 2031

Q3 2032

Trials by Indication[1]

Multiple Sclerosis4 trials

Oral1 trial

Schizophrenia1 trial

Pregnancy1 trial

Adult1 trial

Multiple Sclerosis (MS) - Relapsing-remitting1 trial

Peripheral Artery Disease1 trial

Unspecified3 trials

FDA Approval Timeline[4]

References

Drug Info

Quick Facts

Patent Landscape[5]

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