Roluperidone

Summary

Roluperidone (CHEMBL4297605) is a phase-3 clinical-stage small molecule; indicated across 1 condition.

At a glance

• Status: Max clinical phase 3 (not approved)
• Modality: Small molecule
• Indications: 1 condition
• Clinical trials: 3
• Chemistry: 366.4 Da · C22H23FN2O2

Identifiers

Drug identity and classification

Field	Value
ChEMBL ID	CHEMBL4297605
Name	Roluperidone
Type	Small molecule
Max phase	3
FDA approved	no
PubChem CID	9799284
Molecular formula	C22H23FN2O2
Molecular weight	366.4
InChIKey	RNRYULFRLCBRQS-UHFFFAOYSA-N

SMILES: C1CN(CCC1CN2CC3=CC=CC=C3C2=O)CC(=O)C4=CC=C(C=C4)F

IUPAC name: 2-[[1-[2-(4-fluorophenyl)-2-oxoethyl]piperidin-4-yl]methyl]-3H-isoindol-1-one

Also known as: FMI, MIN-101 FREE BASE, Roluperidona, Roluperidone, ROLUPERIDONE, Ruloperidone

Parent form; salt/anhydrous children: CHEMBL4298043

Patent coverage: 27 distinct patent families (92 SureChEMBL compound mentions), from 1 matched compound structure(s). Mentions count patents naming the compound (not distinct inventions), so promiscuous / reference molecules inflate the mention figure — families are the dedup metric.

Targets

Targets

Broader ChEMBL bioactivity targets: 3 (assay-derived). Sample: 5-hydroxytryptamine receptor 1A, 5-hydroxytryptamine receptor 2A, Sigma intracellular receptor 2.

Bioactivity

ChEMBL activities: 4 potent at pChembl ≥ 5 of 4 total. Top 100 by potency (10 = 0.1 nM, 6 = 1 µM):

Target	pChembl	Type	Value	Unit	Activity ID
HTR1A	8.12	Ki	7.53	nM	CHEMBL_ACT_24977812
HTR2A	8.12	Ki	7.5	nM	CHEMBL_ACT_25470399
TMEM97	8.09	Ki	8.19	nM	CHEMBL_ACT_24977806
TMEM97	8.09	Ki	8.2	nM	CHEMBL_ACT_25470392

Target pathways

No target-pathway data for this drug (no mapped target genes).

Indications & clinical

Indications

1 indication record carries no mapped disease name (EFO/MeSH-only); none shown.

Clinical trials

Total trials: 3.

Phase distribution

Phase	Trials
PHASE3	2
PHASE1	1

Top trials by phase / activity

NCT	Phase	Status	Title
NCT07565428	PHASE3	RECRUITING	Study to Evaluate Efficacy and Safety of Roluperidone in Adult Subjects With Negative Symptoms and Stable Positive Symptoms of Schizophrenia and to Evaluate the Relapse Rate of Roluperidone and Antipsychotic Medications
NCT03397134	PHASE3	COMPLETED	Study to Evaluate Efficacy and Safety of Roluperidone (MIN-101) in Adult Patients With Negative Symptoms of Schizophrenia
NCT06107803	PHASE1	COMPLETED	A Study to Evaluate the Safety, Tolerability, Pharmacodynamics, and Pharmacokinetics of Co-Administration of Roluperidone and Olanzapine in Adult Subjects With Moderate to Severe Negative Symptoms of Schizophrenia

Clinical evidence (CIViC)

No CIViC predictive evidence (expected for non-precision-medicine drugs).

Pharmacology

Pharmacogenomics

No PharmGKB pharmacogenomic data curated for this drug.

Related molecules

Related molecules

No competitor molecules sharing a primary target (ChEMBL phase ≥2 or PubChem drug-class).