RASP-101

**RASP-101** is a controlled-release, nanoparticulate, intravenous formulation of dactinomycin (actinomycin D, marketed as Cosmegen® by Ovation Pharmaceuticals), an established cytotoxic antibiotic that inhibits RNA synthesis by binding DNA. Developed by Rasna Therapeutics to repurpose it for acute myeloid leukemia (AML), particularly NPM1-mutated subtypes, it aims to enable weekly or biweekly dosing to maximize efficacy against refractory/relapsed disease while minimizing dose-limiting oral mucositis seen with unformulated dactinomycin. Preclinical studies demonstrate improved tolerability and pharmacokinetics compared to the free drug, with potential for 505(b)(2) regulatory pathway approval leveraging the original FDA approvals for Wilms' tumor, Ewing's sarcoma, and other solid tumors.[1][3][11]