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Olorofim

Olorofim, also known as F901318, is an investigational antifungal drug currently being studied in clinical trials for the treatment of invasive fungal infections. These trials are evaluating olorofim’s effectiveness, safety, and pharmacokinetics in various patient populations and dosing regimens. The drug shows potential as a novel treatment option, especially for infections resistant to current therapies.

Table of Contents

What is Olorofim?

Olorofim, also known by its research name F901318, is a new antifungal medication being developed to treat serious fungal infections[1]. It belongs to a novel class of antifungal drugs, which means it works differently from existing medications used to treat fungal infections[2].

How Does Olorofim Work?

Olorofim has a unique mechanism of action, which means it fights fungal infections in a way that’s different from other antifungal drugs. This new approach makes it effective against some fungi that have become resistant to other treatments[2]. Its novel mechanism also means it may have fewer drug interactions and a different safety profile compared to existing antifungal medications.

What Conditions Does Olorofim Treat?

Olorofim is being studied for the treatment of invasive fungal infections. These are serious infections that occur when fungi enter the bloodstream and spread throughout the body. Specifically, Olorofim has shown promise in treating infections caused by:

  • Aspergillus species: A type of mold that can cause severe lung infections[1]
  • Lomentospora prolificans: A rare but often fatal fungal infection[1]
  • Scedosporium species: Another group of fungi that can cause serious infections[1]
  • Other resistant fungi: Including some that don’t respond well to current treatments[1]

Olorofim is particularly important for patients who have infections that don’t respond to other antifungal treatments or for those who can’t tolerate standard therapies[1].

How is Olorofim Administered?

Olorofim is taken orally, which means it’s given as a tablet that you swallow[1]. The typical dosing schedule includes:

  • A loading dose: This is a higher dose given at the start of treatment to quickly reach an effective level of the drug in your body. For Olorofim, this is usually 150 mg taken twice a day on the first day[2].
  • A maintenance dose: This is the regular dose taken for the rest of the treatment period. For Olorofim, this is typically 90 mg taken twice a day[2].

The duration of treatment can vary depending on the specific infection and how well you respond to the medication. In some studies, patients have taken Olorofim for up to 84 days[1].

Clinical Studies on Olorofim

Olorofim is currently being studied in several clinical trials to evaluate its effectiveness and safety. These studies include:

  • A Phase IIb study comparing Olorofim to standard treatments for invasive aspergillosis[2]
  • Studies looking at how Olorofim works in people with kidney or liver problems[3][4]
  • A study examining how Olorofim is absorbed, processed, and eliminated by the body[5]

These studies help researchers understand how well Olorofim works, how it should be dosed, and what side effects it might cause.

Potential Side Effects

As with all medications, Olorofim may cause side effects. The full range of potential side effects is still being studied. In clinical trials, researchers carefully monitor for any adverse events (unwanted effects) that occur during treatment[6]. It’s important to report any unusual symptoms to your healthcare provider if you’re taking Olorofim.

Special Considerations

Researchers are studying how Olorofim works in people with certain health conditions:

  • Kidney problems: A study is looking at how Olorofim is processed in people with severe kidney impairment[3]
  • Liver problems: Another study is examining how Olorofim works in people with mild to moderate liver impairment[4]

These studies will help doctors understand if the dose of Olorofim needs to be adjusted for patients with kidney or liver conditions.

Aspect Details
Drug Name Olorofim (also known as F901318)
Type of Drug Antifungal
Target Conditions Invasive fungal infections, including those caused by Aspergillus, Lomentospora prolificans, Scedosporium, and other resistant fungi
Administration Primarily oral tablets; some studies on intravenous formulation
Clinical Trial Phases Phase I, II, and III studies ongoing
Key Study Aspects Efficacy, safety, pharmacokinetics, dosing regimens, use in special populations (e.g., renal/hepatic impairment)
Potential Advantages Novel mechanism of action, potential efficacy against resistant fungi, oral formulation

FAQ

  • What is olorofim? Olorofim is an investigational antifungal drug being studied for the treatment of invasive fungal infections. It has a novel mechanism of action that may be effective against resistant fungi.
  • What types of fungal infections is olorofim being studied for? Olorofim is being evaluated for invasive fungal infections caused by organisms like Aspergillus species, Lomentospora prolificans, Scedosporium species, and other resistant fungi.
  • How is olorofim administered? Olorofim is being studied as an oral medication in tablet form. Some trials are also evaluating intravenous formulations.
  • What phase of clinical trials is olorofim currently in? Olorofim is being studied in various phases, including Phase I, II, and III clinical trials, depending on the specific study and patient population.
  • Are there any known side effects of olorofim? The clinical trials are evaluating the safety profile of olorofim. Common methods to assess safety include monitoring for treatment-emergent adverse events, changes in vital signs, laboratory parameters, and electrocardiogram findings.

Ongoing Clinical Trials on Olorofim

  • Study on the Effectiveness and Safety of Olorofim vs. Liposomal Amphotericin B for Patients with Invasive Aspergillosis

    Not recruiting

    1 1 1 1
    Investigated drugs:
    Belgium France Germany Italy The Netherlands Spain

Glossary

  • Invasive Fungal Infections: Serious infections caused by fungi that spread throughout the body, often affecting people with weakened immune systems.
  • Aspergillus: A type of mold that can cause serious lung infections in some people.
  • Lomentospora prolificans: A type of fungus that can cause severe infections, especially in people with weakened immune systems.
  • Scedosporium: A group of fungi that can cause various infections, including lung and brain infections.
  • Pharmacokinetics: The study of how a drug moves through the body, including how it's absorbed, distributed, metabolized, and eliminated.
  • Bioavailability: The proportion of a drug that enters the circulation when introduced into the body and so is able to have an active effect.
  • Loading dose: An initial higher dose of a drug given at the beginning of a course of treatment before dropping to a lower maintenance dose.
  • Maintenance dose: The amount of a drug that is given to keep the drug at a constant level in the body.
  • Adverse event: Any unfavorable and unintended sign, symptom, or disease temporarily associated with the use of a medical treatment or procedure.
  • Galactomannan index: A test used to detect a molecule found in the cell wall of some fungi, used to diagnose and monitor certain fungal infections.

References

  1. https://clinicaltrials.gov/study/NCT03583164
  2. https://clinicaltrials.eu/trial/study-on-the-effectiveness-and-safety-of-olorofim-vs-liposomal-amphotericin-b-for-patients-with-invasive-aspergillosis/
  3. https://clinicaltrials.gov/study/NCT05200286
  4. https://clinicaltrials.gov/study/NCT04752540
  5. https://clinicaltrials.gov/study/NCT04039880
  6. https://clinicaltrials.gov/study/NCT02808741