ORH-0952
Phase 2- Indications
- Acute myeloid leukemia
Company intelligence / Profile preview
Oral arsenic trioxide capsule ORH‑2014 achieved required target exposure at 15 mg once daily in a completed Phase 1 study. The product demonstrated bioavailability and pharmacokinetic exposures similar to IV ATO and was generally well-tolerated. It received orphan drug designation from both FDA and EMA. Plans were made for a single registrational study for accelerated approval in newly diagnosed APL patients before the asset was acquired by Syros Pharmaceuticals
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