Siremadlin succinate is under clinical development by Novartis and currently in the Phase I and Phase II 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 Siremadlin succinate’s likelihood of approval (LoA) and phase transition for Myelofibrosis took place on 16 Nov 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 16 Nov 2022 increased Siremadlin succinate’s LoA and PTSR for Post-Essential Thrombocythemia Myelofibrosis (Post-ET MF), and increased LoA and PTSR for Post-Polycythemia Vera Myelofibrosis (PPV-MF).

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

Siremadlin succinate overview

Siremadlin succinate (HDM-201) is under development for the treatment of wild type TP53 characterized advanced or metastatic solid tumors, hematological tumors including acute lymphocytic leukemia, acute myelocytic leukemia, myelodysplastic syndrome, metastatic colorectal cancer, metastatic uveal melanoma, dedifferentiated liposarcoma well differentiated liposarcoma and primary myelofibrosis including post-essential thrombocythemia (ET) (PET-MF) and post-polycythemia vera (PV) myelofibrosis (PPV-MF). The small molecule is administered orally and targets HDM2/P53. HDM2 (human double minute 2) is a human homolog of MDM2 (murine double minute 2). it was also under development for the treatment of newly diagnosed acute myeloid leukemia, relapsed and refractory acute myeloid leukemia.

Novartis overview

Novartis is a healthcare company that focuses on the discovery, development, manufacture and marketing of prescription and generic pharmaceutical products and eye care products. It provides drugs for the treatment of cancer, cardiovascular diseases, dermatological conditions, neurological disorders, ophthalmic and respiratory diseases, immune disorders, and infections, among others. The company offers generic medicines and biosimilars through Sandoz. Novartis conducts research in various disease areas through The Novartis Institutes for BioMedical Research (NIBR). The company operates through a network of subsidiaries and offices across the Americas, Europe, the Middle East, Africa, and Asia-Pacific. Novartis is headquartered in Basel, Switzerland.

Quick View Siremadlin succinate LOA Data

Report Segments
  • Innovator
Drug Name
  • Siremadlin succinate
Administration Pathway
  • Oral
Therapeutic Areas
  • Oncology
Key Developers
Highest Development Stage
  • Phase II

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.