Milademetan is under clinical development by Rain Therapeutics and currently in the Phase II and Phase III in clinical pathway. The characteristics of the clinical trial as well as other attributes related to the drug, regulations, and company play a fundamental role in ensuring the likelihood of transition that the drug moves from its current development stage to next.

According to GlobalData, the latest event to affect Milademetan’s likelihood of approval (LoA) and phase transition for Breast Cancer took place on 13 Dec 2022, which increased the likelihood that the drug progresses to the next phase in its clinical pathway and increased the likelihood of final approval for this indication.

In addition, the same event on 13 Dec 2022 increased Milademetan’s LoA and PTSR for Lung Cancer.

GlobalData uses proprietary data and analytics to provide a complete picture of this assessment in their Milademetan Likelihood of Approval (LoA) and Phase Transition Success Rate (PTSR) Report.

Milademetan overview

Milademetan is under development for the treatment of advanced solid tumors, liposarcoma, dedifferentiated liposarcoma, refractory or relapsed acute myeloid leukemia (AML),  pancreatic cancer, lung cancer, breast cancer, biliary tumor and malignant pleural mesothelioma (MPM). The drug candidate is administered orally as a capsule. The drug candidate acts by targeting murine double minute 2 (MDM2) protein.

It was also under development for acute lymphocytic leukemia (ALL), Merkel cell carcinoma, multiple myeloma, soft tissue sarcoma, lymphomas, chronic myelogenous leukemia (CML) and myelodysplastic syndrome.

Rain Therapeutics overview

Rain Therapeutics is a biotechnology company that discovers, develops and translates cancer therapies. It is investigating its lead product candidate milademetan, an oral small molecule, inhibitor of mouse double minute 2 (MDM2) to treat well-differentiated (WD) and dedifferentiated (DD) liposarcoma, Merkel cell carcinoma, amplified and advanced solid tumors. The company is also evaluating a RAD52 inhibiting program targeting homologous recombination deficiencies (HRD+) and loss of function of several pathway constituents including BRCA1/2, PALB2 in breast, prostate, pancreatic, ovarian and other tumors. Rain Therapeutics is headquartered in Newark, California, the US.

Quick View Milademetan LOA Data

Report Segments
  • Innovator
Drug Name
  • Milademetan
Administration Pathway
  • Oral
Therapeutic Areas
  • Oncology
Key Developers
  • Sponsor Company: Rain Therapeutics
  • Originator: Rigel Pharmaceuticals
Highest Development Stage
  • Phase III

GlobalData, the leading provider of industry intelligence, provided the underlying data, research, and analysis used to produce this article.

GlobalData’s Likelihood of Approval analytics tool dynamically assesses and predicts how likely a drug will move to the next stage in its clinical pathway (PTSR), as well as how likely the drug will be approved (LoA). This is based on a proprietary algorithm built from the drugs’ sales forecast, regulatory milestones, cost forecasts, WACC rate and other proprietary data sources found on GlobalData’s Pharmaceutical Intelligence Center.