Olorofim

Summary

Olorofim (CHEMBL4297609) is a phase-3 clinical-stage small molecule; indicated across 6 conditions including aspergillosis and fungal infectious disease.

At a glance

• Status: Max clinical phase 3 (not approved)
• Modality: Small molecule
• Indications: 6 conditions
• Clinical trials: 17
• Chemistry: 498.6 Da · C28H27FN6O2

Identifiers

Drug identity and classification

Field	Value
ChEMBL ID	CHEMBL4297609
Name	Olorofim
Type	Small molecule
Max phase	3
FDA approved	no
PubChem CID	91885568
Molecular formula	C28H27FN6O2
Molecular weight	498.6
InChIKey	SUFPWYYDCOKDLL-UHFFFAOYSA-N

SMILES: CC1=CC(=C(N1C)C(=O)C(=O)NC2=CC=C(C=C2)N3CCN(CC3)C4=NC=C(C=N4)F)C5=CC=CC=C5

IUPAC name: 2-(1,5-dimethyl-3-phenylpyrrol-2-yl)-N-[4-[4-(5-fluoropyrimidin-2-yl)piperazin-1-yl]phenyl]-2-oxoacetamide

Also known as: F-901318, F901318, Olorofim, OLOROFIM, C0088463

Patent coverage: 35 distinct patent families (90 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

No target linkage available.

Bioactivity

No ChEMBL bioactivity rows at pChembl ≥ 5 (expected for biologics / antibodies).

Target pathways

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

Indications & clinical

Indications

6 indications (0 at ChEMBL trial phase 4). Phase below is the highest clinical-trial phase recorded for this drug against each disease — not the molecule’s overall approval status (that is in the Summary).

Indication	Trial phase	MONDO	EFO
aspergillosis	3	MONDO:0005657	EFO:0007157
fungal infectious disease	2	MONDO:0002041	MONDO:0002041
acute myeloid leukemia	1	MONDO:0018874	EFO:0000222
liver disorder	1	MONDO:0005154	EFO:0001421
kidney disorder	1	MONDO:0005240	EFO:0003086
fungal lung infectious disease	1	MONDO:0005766	EFO:0007278

Clinical trials

Total trials: 17.

Phase distribution

Phase	Trials
PHASE1	13
PHASE2	2
PHASE3	1
PHASE1/PHASE2	1

Top trials by phase / activity

NCT	Phase	Status	Title
NCT05101187	PHASE3	ACTIVE_NOT_RECRUITING	Olorofim Aspergillus Infection Study
NCT07385638	PHASE2	NOT_YET_RECRUITING	Olorofim in Early Coccidioidal Meningitis
NCT02856178	PHASE1/PHASE2	WITHDRAWN	Study on Safety and Pharmacokinetics of Intravenous F901318 for Fungal Prophylaxis in AML Patients
NCT03583164	PHASE2	COMPLETED	Evaluate F901318 (Olorofim) Treatment of Invasive Fungal Infections in Participants Lacking Treatment Options
NCT02142153	PHASE1	COMPLETED	F901318 Single Ascending Dose Study in Healthy Male Volunteers
NCT02342574	PHASE1	COMPLETED	F901318 Multiple Ascending Dose Study
NCT02394483	PHASE1	COMPLETED	Single Ascending Oral Dose Study of F901318
NCT02730442	PHASE1	COMPLETED	Study of Potential for Interaction of Fluconazole With F901318
NCT02912026	PHASE1	WITHDRAWN	Radiolabelled IV and Oral Metabolism Study of F901318
NCT03076905	PHASE1	WITHDRAWN	Pharmacokinetics of IV Formulation
NCT03095547	PHASE1	WITHDRAWN	Drug/Drug Interactions With F901318
NCT03340597	PHASE1	COMPLETED	Assessment of Varying Oral Dosing Regimens for F901318 in Healthy Subjects
NCT04039880	PHASE1	COMPLETED	Absorption, Metabolism and Excretion of 14C-olorofim in Man
NCT04171739	PHASE1	COMPLETED	Drug-drug Interaction (DDI) Study to Assess Effect of Itraconazole and Rifampicin Upon Olorofim
NCT04207957	PHASE1	COMPLETED	A Biopharmaceutics Study to Assess the Pharmacokinetics of Single Oral and IV Doses of Olorofim
NCT04752540	PHASE1	COMPLETED	A Phase I Study to Assess the Pharmacokinetics of Olorofim in Subjects With Hepatic Impairment
NCT05200286	PHASE1	COMPLETED	A Phase I Study to Assess the Pharmacokinetics of Olorofim in Subjects With Renal Impairment

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).