Phuturdex › Drugs › Mesutoclax
Drugs in development · updated 13 November 2026
Mesutoclax: clinical trials and development status
Other names and codes: ICP-248
As of 13 November 2026 Mesutoclax is in 8 active clinical trials (recruiting or ongoing, phases I–III) for 5 diseases. The most advanced phase is III.
Authorisation
- EU no (EMA)
- Italy not in the AIFA register
- Germany not available
- US no (FDA)
Sources: EMA, AIFA register (open data), FDA. For Germany only the EU centralised authorisation is shown: the national BfArM register is not one of our sources.
Map of sites in Europe with recruitment status, every trial and an email when something changes. Full access free until 31 March 2027, no card needed.
What it is
An orally bioavailable inhibitor of the anti-apoptotic protein B-cell lymphoma 2 (Bcl-2), with potential pro-apoptotic and antineoplastic activities. Upon oral administration, mesutoclax targets, binds to and inhibits the activity of Bcl-2. This restores caspase-mediated apoptosis in tumor cells. Bcl-2 is overexpressed in many cancers and plays an important role in the negative regulation of apoptosis. Its expression is associated with increased drug resistance and tumor cell survival.
Diseases studied
For each disease: the drug’s most advanced phase and active trials, with the reference trial on ClinicalTrials.gov.
| Disease | Most advanced phase | Active trials | Reference trial |
|---|---|---|---|
| Acute myeloid leukemia | III | 2 | NCT07925190 |
| Hematologic neoplasm | II–III | 2 | NCT06378138 |
| Mantle cell lymphoma | III | 2 | NCT07784101 |
| Lymphoma, B-Cell, Marginal Zone | III | 1 | NCT07896590 |
| Myelodysplastic Syndromes | I | 1 | NCT06656494 |
Everything on Mesutoclax
In Phuturdex you get every trial with sponsors, countries and dates, development events, FDA and EMA approvals, patents and exclusivities, orphan designations and safety alerts, with PDF and Excel export. Free until 31 March 2027.
Open in Phuturdex →Source: Phuturdex analysis of ClinicalTrials.gov (U.S. National Library of Medicine), FDA and EMA data, updated 13 November 2026. Active trials = recruiting or ongoing, phases I–III. Diseases are those named by each trial (NLM MeSH terms). The estimated launch, when shown, refers to the United States and is a Phuturdex calculation described on the Method page, not official data: the drug may already be marketed in other countries.