Olorofim

Phase 2Small molecule

FF2G Biotech GmbH

Indications

Total Trials

Active Trials

Competitors

Pipeline

Status by Indication[3][1]

Indication

Coccidioidal MeningitisRecruiting

Coccidioidal MeningitisPhase 2

Recruiting

Timeline

Expected Milestones

Q2 2027

Phase 2Recruiting

Coccidioidal Meningitis

NCT07385638

Q3 2028

Phase 2Not yet recruiting

Coccidioidomycosis

NCT07712484

Clinical

Trials by Indication[1]

Interaction1 trial

Drug-drug Interaction (DDI) Study to Assess Effect of Itraconazole and Rifampicin Upon Olorofim

Completed·FF2G Biotech GmbH·Phase 1·NCT04171739·24 enrolled

Oral1 trial

A Biopharmaceutics Study to Assess the Pharmacokinetics of Single Oral and IV Doses of Olorofim

Completed·FF2G Biotech GmbH·Phase 1·NCT04207957·24 enrolled

Invasive Fungal Infections1 trial

Evaluate F901318 (Olorofim) Treatment of Invasive Fungal Infections in Participants Lacking Treatment Options

Completed·FF2G Biotech GmbH·Phase 2·NCT03583164·203 enrolled

Absorption1 trial

Absorption, Metabolism and Excretion of 14C-olorofim in Man

Completed·FF2G Biotech GmbH·Phase 1·NCT04039880·12 enrolled

Renal Impairment1 trial

A Phase I Study to Assess the Pharmacokinetics of Olorofim in Subjects With Renal Impairment

Completed·FF2G Biotech GmbH·Phase 1·NCT05200286·16 enrolled

4 more indications

Hepatic Impairment1 trial

A Phase I Study to Assess the Pharmacokinetics of Olorofim in Subjects With Hepatic Impairment

Completed·FF2G Biotech GmbH·Phase 1·NCT04752540·32 enrolled

Invasive Aspergillosis1 trial

Phase III, Adjudicator-blinded, Randomised Study to Evaluate Efficacy and Safety of Treatment With Olorofim Versus Treatment With AmBisome® Followed by Standard of Care in Patients With Invasive Fungal Disease Caused by Aspergillus Species

Completed·FF2G Biotech GmbH·Phase 3·NCT05101187·225 enrolled

Coccidioidomycosis1 trial

COCCIMETRICS: A Phase II, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate Measures for Endpoint Derivation in Patients With Progressive or Refractory Disseminated Coccidioidomycosis (DCM) Treated With Olorofim Plus Baseline Standard of Care (SOC) or With Placebo Plus Baseline SOC

Not yet recruiting·FF2G Biotech GmbH·Phase 2·NCT07712484·50 enrolled

Coccidioidal Meningitis1 trial

Phase 2, Open-label Evaluation of Olorofim in Early Coccidioidal Meningitis

Recruiting·FFariba Donovan·Phase 2·NCT07385638·12 enrolled

Sources

References

[1]
ClinicalTrials.gov — 9 trial records for Olorofim. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Olorofim compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Olorofim. EMBL-EBI & Wellcome Sanger Institute.
[4]
SEC EDGAR — F2G Biotech GmbH company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Highest Phase: Phase 2[1]
Company: FF2G Biotech GmbH