Skip to content

MDM2 inhibitor · small molecule

siremadlin

1 active trials across 5 of our biomarkers, targeting MDM2. Not approved for any biomarker on marked.bio yet.

Also known as HDM201.

Counts only trials that select patients by one of the biomarkers on marked.bio, not every trial of this drug.

Biomarkers

Biomarker	Active trials	All trials	Furthest active phase
ALK fusion	1	1	Phase 2
BRAF V600E	1	1	Phase 2
NTRK1/2/3 fusion	1	1	Phase 2
ROS1 fusion	1	1	Phase 2
FLT3 mutation (ITD/TKD)	0	2	–

Trials

1 of 3 trials shown

A Study Evaluating the Activity of Anti-cancer Treatments Targeting Tumor Molecular Alterations/Characteristics in Advanced / Metastatic Tumors.

Recruiting Phase 2 Centre Leon Berard Started 2020Primary completion 2026-10 NCT04116541

siremadlinribociclibcabozantinibalectinibregorafenibtrametinib FDA EUdabrafenib FDA EUAvapritinib

…r amplification and/or rearrangement of VEGFR1-3, TIE-2, KIT, RET, RAF1, BRAF (other than V600 mutations), CRAF, HRAS, PDGFR, FGFR1-2, FLT3 and/or CSFR1, and/or amplification of the ligands, an…

BRAF V600EALK fusionROS1 fusionNTRK1/2/3 fusionMalignant Solid Tumor
HDM201 Added to CT in R/R or Newly Diagnosed AML

Withdrawn Phase 1/2 Novartis Started 2019 NCT03760445

siremadlincytarabinedaunorubicinidarubicinmidostaurin FDA EUCPX-351posaconazolemidazolam

For Part 2 Expansion Cohort 2: documented presence of FLT3 mutation (ITD or TKD ) and suitable for midostaurin treatment as per investigator judgement.

FLT3 mutation (ITD/TKD)Leukemia, Myeloid, Acute
HDM201 and Midostaurin (HDMM) in Relapsed/Refractory AML With FLT3mut and TP53wt.

Terminated Phase 1 Insel Gruppe AG, University Hospital Bern Started 2020 NCT04496999

siremadlinmidostaurin FDA EU

AML with FLT3-ITD or FLT3-TKD and TP53wt.

FLT3 mutation (ITD/TKD)AML, Adult