Dimethyl fumarate DR is under clinical development by Biogen and currently in Phase I for Systemic Sclerosis (Scleroderma). According to GlobalData, Phase I drugs for Systemic Sclerosis (Scleroderma) have an 84% phase transition success rate (PTSR) indication benchmark for progressing into Phase II. GlobalData’s report assesses how Dimethyl fumarate DR’s drug-specific PTSR and Likelihood of Approval (LoA) scores compare to the indication benchmarks. Buy the report here.

GlobalData tracks drug-specific phase transition and likelihood of approval scores, in addition to indication benchmarks based off 18 years of historical drug development data. Attributes of the drug, company and its clinical trials play a fundamental role in drug-specific PTSR and likelihood of approval.

Dimethyl fumarate DR overview

Dimethyl fumarate (Tecfidera) is the methyl ester of fumaric acid, acts as an anti-inflammatory and immunomodulatory agent. It is formulated as gastro-resistant hard capsules or delayed release capsules for oral route of administration. Tecfidera is indicated for the treatment of relapsing – remitting multiple sclerosis (RRMS).

The drug candidate is under development for the treatment of primary progressive multiple sclerosis and systemic sclerosis-associated pulmonary arterial hypertension (SSc-PAH). It is administered through oral route. It was also under development for the treatment of psoriasis, rheumatoid arthritis and relapsed/refractory chronic lymphocytic leukemia or small lymphocytic leukemia.

Biogen overview

Biogen is a biopharmaceutical company that discovers, develops, and delivers drugs and biosimilars for the treatment of various neurological and neurodegenerative diseases. The company’s marketed products include Avonex (interferon beta-1a), Vumerity (diroximel fumarate), Tysabri (natalizumab), Tecfidera (dimethyl fumarate), Fampyra (prolonged-release fampridine tablets), and Plegridy (peginterferon beta-1a) for the treatment of multiple sclerosis (MS); Spinraza (nusinersen) for spinal muscular atrophy (SMA); Aduhelm (aducanumab-avwa) for alzheimer’s disease, and Fumaderm (fumaric acid esters) for severe plaque psoriasis. It has several product candidates targeting various indications such as MS, Parkinson’s disease, Lupus, Depression, CNS and neuromuscular disorders, Amyotrophic Lateral Sclerosis, and Alzheimer’s disease. The company sells its products through direct sales force, marketing groups, and distributors in the Americas, Europe, Asia, and other territories. Biogen is headquartered in Cambridge, Massachusetts, the US.

For a complete picture of Dimethyl fumarate DR’s drug-specific PTSR and LoA scores, buy the report here.

This content was updated on 20 February 2024

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GlobalData, the leading provider of industry intelligence, provided the underlying data, research, and analysis used to produce this article.

GlobalData’s Likelihood of Approval analytics tool dynamically assesses and predicts how likely a drug will move to the next stage in clinical development (PTSR), as well as how likely the drug will be approved (LoA). This is based on a combination of machine learning and a proprietary algorithm to process data points from various databases found on GlobalData’s Pharmaceutical Intelligence Center.