- |||||||||| Olorofim (orotomide) / F2G
Review, Journal: Review of the Novel Investigational Antifungal Olorofim. (Pubmed Central) - Aug 6, 2020 Although published clinical outcome data have been limited to case reports to date, the results against invasive and refractory infections are promising. This review describes the mechanism of action of olorofim, its in vitro spectrum of activity, and what is currently known about its pharmacokinetic profile and clinical efficacy.
- |||||||||| Olorofim (orotomide) / F2G
Enrollment change, Trial completion date, Trial primary completion date: A Biopharmaceutics Study to Assess the Pharmacokinetics of Single Oral and IV Doses of Olorofim (clinicaltrials.gov) - Jul 23, 2020 P1, N=24, Recruiting, This review describes the mechanism of action of olorofim, its in vitro spectrum of activity, and what is currently known about its pharmacokinetic profile and clinical efficacy. N=12 --> 24 | Trial completion date: Feb 2020 --> Dec 2023 | Trial primary completion date: Feb 2020 --> Jan 2023
- |||||||||| Review, Journal: Aspiring Antifungals: Review of Current Antifungal Pipeline Developments. (Pubmed Central) - Mar 1, 2020
Additionally, novel first-in-class agents such as ibrexafungerp, an oral glucan synthase inhibitor with activity against various resistant fungal isolates, and olorofim, a pyrimidine synthesis inhibitor with a broad spectrum of activity and oral formulation, will be reviewed. Various other innovative antifungal agents and classes, including MGCD290, tetrazoles, and fosmanogepix, will also be examined.
- |||||||||| Review, Journal: Hope on the Horizon: Novel Fungal Treatments in Development. (Pubmed Central) - Feb 27, 2020
In addition, we will describe neurapheresis, a device used as adjunctive therapy for cryptococcosis. With a field full of novel treatments for fungal infections, the future looks promising.
- |||||||||| Olorofim (orotomide) / Shionogi
Trial completion date, Trial initiation date, Trial primary completion date: Radiolabelled IV and Oral Metabolism Study of F901318 (clinicaltrials.gov) - Aug 1, 2018 P1, N=10, Not yet recruiting, Recruiting --> Completed Trial completion date: Sep 2017 --> Jul 2019 | Trial primary completion date: Sep 2017 --> Jul 2019 | Initiation date: Jun 2017 --> May 2019
- |||||||||| Olorofim (orotomide) / F2G
Enrollment change, Trial completion date, Trial initiation date, Trial withdrawal, Trial primary completion date: Study on Safety and Pharmacokinetics of Intravenous F901318 for Fungal Prophylaxis in AML Patients (clinicaltrials.gov) - Feb 15, 2018 P2a, N=0, Withdrawn, Trial completion date: Sep 2017 --> Jul 2019 | Trial primary completion date: Sep 2017 --> Jul 2019 | Initiation date: Jun 2017 --> May 2019 N=10 --> 0 | Initiation date: Sep 2016 --> Apr 2017 | Not yet recruiting --> Withdrawn | Trial completion date: May 2017 --> Apr 2017 | Trial primary completion date: Mar 2017 --> Apr 2017
- |||||||||| Olorofim (orotomide) / F2G
Enrollment open, Trial completion date, Trial initiation date, Trial primary completion date: Assessment of Varying Oral Dosing Regimens for F901318 in Healthy Subjects (clinicaltrials.gov) - Feb 15, 2018 P1, N=60, Recruiting, N=18 --> 0 | Not yet recruiting --> Withdrawn Not yet recruiting --> Recruiting | Trial completion date: Mar 2018 --> Apr 2018 | Initiation date: Dec 2017 --> Dec 2017 | Trial primary completion date: Mar 2018 --> Apr 2018
- |||||||||| Olorofim (orotomide) / F2G
Trial withdrawal: Pharmacokinetics of IV Formulation (clinicaltrials.gov) - Nov 1, 2017 P1, N=0, Withdrawn, Not yet recruiting --> Recruiting | Trial completion date: Mar 2018 --> Apr 2018 | Initiation date: Dec 2017 --> Dec 2017 | Trial primary completion date: Mar 2018 --> Apr 2018 Not yet recruiting --> Withdrawn
- |||||||||| Olorofim (orotomide) / F2G
Enrollment change, Trial withdrawal: Drug/Drug Interactions With F901318 (clinicaltrials.gov) - Nov 1, 2017 P1, N=0, Withdrawn, Not yet recruiting --> Withdrawn N=48 --> 0 | Not yet recruiting --> Withdrawn
- |||||||||| Olorofim (orotomide) / F2G
Trial initiation date, Trial primary completion date: Radiolabelled IV and Oral Metabolism Study of F901318 (clinicaltrials.gov) - Mar 7, 2017 P1, N=10, Not yet recruiting, Recruiting --> Completed | N=24 --> 40 Initiation date: Nov 2016 --> Jun 2017 | Trial primary completion date: Jan 2017 --> Sep 2017
- |||||||||| Olorofim (orotomide) / F2G
Enrollment open, Trial primary completion date: ORALMAD: Multiple Ascending Oral Dose Study of F901318 in Healthy Subjects (clinicaltrials.gov) - Feb 14, 2017 P1, N=24, Recruiting, Initiation date: Nov 2016 --> Jun 2017 | Trial primary completion date: Jan 2017 --> Sep 2017 Not yet recruiting --> Recruiting | Trial primary completion date: Sep 2016 --> Mar 2017
- |||||||||| Olorofim (orotomide) / F2G
Trial completion, Enrollment change, Trial initiation date, Trial primary completion date: Study of Potential for Interaction of Fluconazole With F901318 (clinicaltrials.gov) - Feb 2, 2017 P1, N=20, Completed, Not yet recruiting --> Recruiting | Trial primary completion date: Sep 2016 --> Mar 2017 Recruiting --> Completed | N=32 --> 20 | Initiation date: Jun 2016 --> Feb 2016 | Trial primary completion date: Sep 2016 --> Jun 2016
- |||||||||| Olorofim (orotomide) / F2G
Trial completion: Evaluation of Immediate Release Tablet (clinicaltrials.gov) - Nov 28, 2016 P1, N=20, Completed, Recruiting --> Completed | N=32 --> 20 | Initiation date: Jun 2016 --> Feb 2016 | Trial primary completion date: Sep 2016 --> Jun 2016 Recruiting --> Completed
- |||||||||| Olorofim (orotomide) / F2G
Trial completion: F901318 Multiple Ascending Dose Study (clinicaltrials.gov) - Sep 19, 2016 P1, N=72, Completed, Recruiting --> Completed Recruiting --> Completed
- |||||||||| Olorofim (orotomide) / F2G
Trial primary completion date: Single Ascending Oral Dose Study of F901318 (clinicaltrials.gov) - Aug 9, 2016 P1, N=40, Recruiting, Recruiting --> Completed Trial primary completion date: Apr 2016 --> Sep 2016
- |||||||||| Olorofim (orotomide) / F2G
Trial primary completion date: F901318 Multiple Ascending Dose Study (clinicaltrials.gov) - Aug 9, 2016 P1, N=72, Recruiting, Trial primary completion date: Apr 2016 --> Sep 2016 Trial primary completion date: Feb 2016 --> Sep 2016
- |||||||||| Olorofim (orotomide) / F2G
Enrollment open: Evaluation of Immediate Release Tablet (clinicaltrials.gov) - Jul 25, 2016 P1, N=20, Recruiting, Trial primary completion date: Feb 2016 --> Sep 2016 Not yet recruiting --> Recruiting
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