US EditionU.S. FDA Grants Orphan Drug Designation to Adcentrx Therapeutics' ADRX-0405 STEAP1 ADC for Gastric Cancer
UNITED STATES, JUL 9 – The FDA's orphan drug status supports ADRX-0405 development for gastric cancer, a rare disease with 30,300 new U.S. cases expected in 2025, highlighting urgent treatment needs.
- On July 8, 2025, the U.S. FDA granted orphan drug designation to Adcentrx Therapeutics' ADRX-0405 STEAP1 ADC for treating gastric cancer.
- This designation followed preclinical success and initiation of a Phase 1a/b trial in January 2025 to evaluate ADRX-0405's safety in advanced solid tumors including gastric cancer.
- The clinical trial enrolls patients across eight U.S. sites in six states, assessing ADRX-0405 for metastatic castration-resistant prostate cancer, lung cancer, and gastric cancer.
- Hui Li, Adcentrx CEO, said receiving orphan designation is a milestone reinforcing ADRX-0405's potential to improve gastric cancer patient outcomes.
- The designation provides benefits like tax credits and market exclusivity, while trial results are expected by the end of 2025 to guide further development.
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U.S. FDA Grants Orphan Drug Designation to Adcentrx Therapeutics' ADRX-0405 STEAP1 ADC for Gastric Cancer
Orphan drug designation highlights the potential for ADRX-0405 to address the high unmet need in gastric cancer
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