Clofazimine is under clinical development by MannKind and currently in Phase III for Mycobacterium Infections. According to GlobalData, Phase III drugs for Mycobacterium Infections have a 50% phase transition success rate (PTSR) indication benchmark for progressing into Pre-Registration. GlobalData’s report assesses how Clofazimine’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.

Clofazimine overview

Clofazimine (QRM-003) is under development for the treatment of pulmonary nontuberculous mycobacterial lung infections. It is a reformulated drug candidate. It is administered through inhalation route as a suspension. It acts by targeting DNA.

MannKind overview

MannKind is a biopharmaceutical company primarily engaged in the development and commercialization of inhaled therapeutic products and devices. The company’s main focus is on addressing unmet medical needs for patients with endocrine and orphan lung diseases. MannKind‘s key offerings include dry-powder formulations and inhalation devices, designed to deliver medicines rapidly and conveniently to the deep lung. Its technologies are used in the treatment of diseases such as diabetes, nontuberculous mycobacterial (NTM) lung disease, pulmonary fibrosis, and pulmonary hypertension. Its flagship product, Afrezza is a rapid-action inhaled insulin used to control high blood sugar in adults with type 1 and type-2 diabetes. MannKind has manufacturing facility in Danbury, Connecticut and sells products to wholesale distributors and specialty pharmacies in the US. MannKind is headquartered in Westlake Village, California, the US.

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

This content was updated on 12 April 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.