Idience said Tuesday that venadaparib, the company’s novel drug candidate for targeted agents, has been designated as an orphan drug by the U.S. Food and Drug Administration.

Idience said Tuesday that its novel drug substance for targeted agents, venadaparib, has been approved as an orphan drug by the U.S. FDA.
Idience said Tuesday that its novel drug substance for targeted agents, venadaparib, has been approved as an orphan drug by the U.S. FDA.

Idience is a subsidiary of Ildong Holdings, the holding company of Ildong Pharmaceutical Group, specializing in novel drug development. The company is now carrying out the clinical development of a new drug pipeline, including venadaparib.

Venadaparib is a novel drug substance with a Poly ADP-ribose polymerase (PARP) inhibitory mechanism, developed as the targeted agent for solid tumors, such as gastric, breast, and ovarian cancer. The FDA approved it as a rare disease treatment substance related to gastric cancer based on the non-clinical research data and the clinical results.

With the FDA’s designation, Idience will receive benefits, including eased regulations, tax cuts, and fee waivers for permission approval. In addition, if the novel drug hits the market, the company will secure exclusive rights for seven years regarding the substance.

The company is conducting a phase 1b clinical trial for venadaparib as a combined treatment of gastric cancer in Korea, China, and the U.S.

“By being selected as an orphan drug, we expect to gain momentum for its commercialization, such as clinical trial and permission approvals,” an Idience official said. “We will seek partnerships and technology transfer while pushing ahead with multinational clinical trials targeted for new drug application (NDA) by 2026.”

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