The FDA granted an orphan drug designation (ODD) to Redx’s zelasudil (RXC007) in August 2023. Zelasudil is an oral, selective rho-associated coiled-coil containing protein kinase 2 (ROCK2) inhibitor for the potential treatment of idiopathic pulmonary fibrosis (IPF). The FDA move will put RedX on the map as one of the key upcoming players in the treatment of IPF, says GlobalData, a leading data and analytics company.

Ramla Salad, Pharma Analyst at GlobalData, comments: “This ODD will support Redx in its development of zelasudil and provide it with commercial incentives such as market exclusivity due to the high unmet need surrounding IPF.”

Key opinion Leaders (KOLs) interviewed by GlobalData have noted that there is a huge unmet need in the IPF space, which is pushing companies to look for incentives such as gaining ODDs and other designations from regulators to support the long-term development of these agents. Phase III agents in development include United Therapeutics’ Tyvaso (treprostinil), Boehringer Ingelheim’s BI-1015550, and FibroGen’s pamrevlumab. All these agents have been awarded ODDs, which support and incentivise their development.

Pamrevlumab is the only agent in the late-stage pipeline with a fast-track designation, meaning FibroGen can frequently meet with the FDA and discuss the drug development plan, which can expedite the review process and potentially lead to faster drug approval.

Salad concludes: “Despite receiving an ODD, it is clear that zelasudil will face intense competition; the agent is still in Phase IIa development while the aforementioned pipeline agents are in Phase III. However, ROCK inhibition has great potential to be a powerful therapeutic tool for the treatment of IPF.”