Olorofim

Overview

Olorofim is under investigation in clinical trial NCT03340597 (Assessment of Varying Oral Dosing Regimens for F901318 in Healthy Subjects).

Indication

No indication information available.

Associated Conditions

No associated conditions information available.

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
A Phase I Study to Assess the Pharmacokinetics of Olorofim in Subjects With Renal Impairment	2022/01/20	NCT05200286	Phase 1	Completed	F2G Biotech GmbH
Olorofim Aspergillus Infection Study	2021/11/01	NCT05101187	Phase 3	Recruiting	F2G Biotech GmbH
A Phase I Study to Assess the Pharmacokinetics of Olorofim in Subjects With Hepatic Impairment	2021/02/12	NCT04752540	Phase 1	Completed	F2G Biotech GmbH
A Biopharmaceutics Study to Assess the Pharmacokinetics of Single Oral and IV Doses of Olorofim	2019/12/23	NCT04207957	Phase 1	Completed	F2G Biotech GmbH
Drug-drug Interaction (DDI) Study to Assess Effect of Itraconazole and Rifampicin Upon Olorofim	2019/11/21	NCT04171739	Phase 1	Completed	F2G Biotech GmbH
Absorption, Metabolism and Excretion of 14C-olorofim in Man	2019/07/31	NCT04039880	Phase 1	Completed	F2G Biotech GmbH
Evaluate F901318 (Olorofim) Treatment of Invasive Fungal Infections in Participants Lacking Treatment Options	2018/07/11	NCT03583164	Phase 2	Completed	F2G Biotech GmbH
Assessment of Varying Oral Dosing Regimens for F901318 in Healthy Subjects	2017/11/13	NCT03340597	Phase 1	Completed	F2G Biotech GmbH
Drug/Drug Interactions With F901318	2017/03/29	NCT03095547	Phase 1	Withdrawn	F2G Biotech GmbH
Pharmacokinetics of IV Formulation	2017/03/10	NCT03076905	Phase 1	Withdrawn	F2G Biotech GmbH

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
No FDA approvals found for this drug.

EMA Drug Approvals

Approved Product	Authorization Holder	Status	Issued Date
No EMA approvals found for this drug.

HSA Drug Approvals

Approved Product	Manufacturer	Approval Number	Dosage Form	Strength	Approval Date
No HSA approvals found for this drug.

NMPA Drug Approvals

Approved Product	Company	Approval Number	Drug Type	Dosage Form	Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

Approved Product	Registration No.	Company	Licence No.	Strength	Registration Date
No PPB approvals found for this drug.

TGA Drug Approvals

Approved Product	ARTG ID	Sponsor	Registration Type	Status	Registration Date
No TGA approvals found for this drug.

Related News

F2G's Novel Antifungal Olorofim Shows Promise Despite FDA Setback, Phase 2b Results Published in The Lancet

3 months ago

F2G's olorofim, the first in a new class of orotomide antifungals, received a complete response letter from the FDA requiring additional data before approval.

F2G Secures $100 Million to Advance Antifungal Olorofim After FDA Rejection

10 months ago

• F2G has raised $100 million to fund late-stage testing of olorofim, an antifungal drug intended to treat invasive aspergillosis, after initial FDA rejection. • The funding round was co-led by AMR Action Fund and ICG, with participation from eight other investors, signaling strong confidence in olorofim's potential. • Olorofim, an orotomide antifungal, targets a key enzyme in fungi and has received Breakthrough Therapy designation, with ongoing Phase 3 trials comparing it to AmBisome. • The investment will support completion of the Phase 3 trial, resubmission to the FDA, and preparations for the potential U.S. launch of olorofim.

F2G's Olorofim Shows 44% Response Rate in Phase 2b Trial for Invasive Fungal Infections

3 years ago

F2G announced positive Phase 2b data for olorofim showing a 44% complete or partial response rate at day 42 in 100 patients with invasive fungal infections who had limited treatment options.

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