Mirogabalin besylate is under clinical development by Daiichi Sankyo and currently in Phase II for Chemotherapy Induced Peripheral Neuropathy. According to GlobalData, Phase II drugs for Chemotherapy Induced Peripheral Neuropathy does not have sufficient historical data to build an indication benchmark PTSR for Phase II. GlobalData uses proprietary data and analytics to create drugs-specific PTSR and LoA in the Mirogabalin besylate LoA Report. 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.

Mirogabalin besylate overview

Mirogabalin besylate (Tarlige) is a gamma-aminobutyric acid (GABA) derivative, acts as an anti convulsant agent. It is formulated as film coated tablets for oral route of administration. Tarlige is indicated for the treatment of neuropathic pain.

Mirogabalin (DS-5565, A200-0700) is under development for the treatment of diabetic peripheral neuropathic pain, chemotherapy-induced peripheral neuropathy, central neuropathic pain after spinal cord injury, diabetic peripheral neuropathy and postherpetic neuralgia. The drug candidate is administered orally as a film coated tablet. The drug candidate acts on alpha(2) delta-1 subunits of voltage-gated calcium channel. It was also under development for treatment of pain associated with fibromyalgia.

Daiichi Sankyo overview

Daiichi Sankyo is a holding company, which carries out the research, development, manufacture, and marketing of pharmaceutical products. The company offers a wide range of prescription drugs, over the counter (OTC) drugs, vaccines, and others. Its portfolio encompasses medicines for cardiovascular, neurological, nephrological, diabetic, metabolic, and infectious diseases, and various types of cancers. Besides cancer, the company’s other research areas include rare diseases and immune disorders. Daiichi Sankyo sells its products through its group companies, and an extensive network of medical representatives. It has operations in North America, South and Central America, Europe, and Asia. Daiichi Sankyo is headquartered in Tokyo, Japan.

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

This content was updated on 2 September 2023

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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.