Clinical trialNCT07895264
Managed Access Program Allowing Access to Olorofim
A study testing Anti Fungal Drug and Olorofim is a novel antifungal drug, run by F2G Ltd.
Trial summary
This is a managed access programme for patients meeting the entry criteria eithe de novo or completing a clinical trial Read more about this study
- Who is it for?
- Ages 6 years and older
- What is being tested?
- Anti Fungal Drug and Olorofim is a novel antifungal drug
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Start not givento not given
- Phase
- Expanded access
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 years and older
- All sexes
- Child, Adult, Older adult
Who may be able to join
- Patients must meet the compassionate access requirements to be eligible for the MAP. These requirements include, but are not limited to:
- Proven, (any body site) or Probable (LTRD) IFI caused by Aspergillus in patients not eligible to receive a treatment with any azole (e.g. due to resistance, intolerance or drug-drug interactions).
- Proven or Probable Lomentospora prolificans* infections
- Other proven* mould IFI *a combination of clinical/host features, radiology and mycology according to the EORTC/MSG Criteria 2019
- Proven CNS Coccidioides in patients with or planned placement of indwelling CNS devices (e.g. reservoirs, shunts, ventriculostomies, or external drainage tubes) or receiving intrathecal (IT) Amphotericin B, when there is failure to previous effective therapies
- Causative organism must be known or predicted to be susceptible to olorofim (susceptibility testing may be required e.g., for Fusarium spp.)
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- Evidence of limited treatment options (e.g., evidence for failure/resistance or intolerance to prior therapy Dose limiting drug-drug interactions (DDIs) or the potential for DDIs
- To provide olorofim for patients transitioning from other olorofim interventional trials when those trials close or continued treatment for patients that completed all study visits, for whom on-going therapy has been judged beneficial, for whom on-going therapy has been judged beneficial, or there is a positive clinical risk-benefit to switch to olorofim treatment as demonstrated by an approved compassionate use request.
- The ability to obtain all necessary regulatory approvals for use of an unlicensed drug in the patient's home country
- The ability to ship olorofim in a meaningful timeframe to be able to influence the patient's outcome.
- Prescribing physician has confirmed they have completed relevant training.
- Patients have been fully informed and have given voluntary written informed consent, or whose legally authorized representative(s) have been fully informed and have given voluntary written informed consent, if applicable, and in compliance with local regulations.
- In exceptional circumstances and as supported by emerging data, chidren (≥ 6 years) may be considered, assuming all of the above entry criteria are met. Each paediatric case will be considered on a case-by-case basis by the F2G medical team.
Who cannot join
- Compassionate use requests will be submitted via Clinigen Direct and the physician will complete the patient access form (PAF) which documents the criteria which apply to each patient. As part of this assessment the following exclusion criteria apply, but are not limited to:
- Suspected or known hypersensitivity to olorofim.
- Adults with invasive aspergillosis who can receive azole therapy and where they are considered an effective option.
- Patients with confirmed DCM involving extra-pulmonary sites with or without ongoing active disease in lungs, progressive or refractory, even in case of failure to azoles
- Patients with chronic, non-invasive aspergillosis syndromes without evidence of invasive disease
- Patients with 'possible' IFI according to the EORTC/MSG criteria (except for Lomentospora prolificans)
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- Patients with underlying pulmonary disease or lung transplant who have evidence for lung colonization with a mould but no corresponding radiological or biopsy evidence for an invasive lung disease.
- Patients receiving treatment limited to supportive care due to predicted short survival time.
- Evidence of hepatic dysfunction with any of the following abnormal laboratory parameters at screening for this MAP:
- Total bilirubin ≥ 2 × upper limit of the normal range (ULN)
- Alanine transaminase or aspartate transaminase ≥ 3 × ULN
- Patients with known cirrhosis or chronic hepatic failure.
- Patients who do not meet the EORTC/MSG criteria (18) for probable L. prolificans or proven IFI e.g., patients with 'possible' IFD or who do not have appropriate host criteria.
- Patients that are currently receiving other investigational drugs via a Compassionate use program
- Patients receiving Human DHODH inhibitors (eg teriflunomide and leflunomide) and/or cannabinoids.
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Trial locations and contacts
No sites are listed yet.
About this study
This is a managed access programme for patients meeting the entry criteria eithe de novo or completing a clinical trial
- Being tested
- Anti Fungal Drug, Olorofim is a novel antifungal drug
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anti Fungal DrugDrug
Novel anti fungal medication in phase 2/3 development
Olorofim is a novel antifungal drugDrug
Olorofim (F903138) is a novel orotomide anti fungal medication
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Expanded access
Sponsor and investigators
- Lead sponsor
- F2G Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07895264
- Sponsor's protocol ID
- F2G-EAP-OLOR-102026
- Status last verified
- Oct 2026
- First submitted
- 14 Oct 2026
- Last updated
- 26 Oct 2026
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Managed Access Program Allowing Access to Olorofim
- ClinicalTrials.gov ID
- NCT07895264
- Acronym / sponsor ID
- F2G-EAP-OLOR-102026
- Study type
- Expanded access
- Recruitment status
- Available
- Lead sponsor
- F2G LtdIndustry (pharma, biotech, devices)
- First posted
- 26 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a managed access programme for patients meeting the entry criteria eithe de novo or completing a clinical trial
Study design
Who may qualify
- Ages
- 6 years and older
- Sex
- All
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (13 listed)
- Patients must meet the compassionate access requirements to be eligible for the MAP. These requirements include, but are not limited to:
- Proven, (any body site) or Probable (LTRD) IFI caused by Aspergillus in patients not eligible to receive a treatment with any azole (e.g. due to resistance, intolerance or drug-drug interactions).
- Proven or Probable Lomentospora prolificans* infections
- Other proven* mould IFI *a combination of clinical/host features, radiology and mycology according to the EORTC/MSG Criteria 2019
- Proven CNS Coccidioides in patients with or planned placement of indwelling CNS devices (e.g. reservoirs, shunts, ventriculostomies, or external drainage tubes) or receiving intrathecal (IT) Amphotericin B, when there is failure to previous effective therapies
Key exclusion criteria (16 listed)
- Compassionate use requests will be submitted via Clinigen Direct and the physician will complete the patient access form (PAF) which documents the criteria which apply to each patient. As part of this assessment the following exclusion criteria apply, but are not limited to:
- Suspected or known hypersensitivity to olorofim.
- Adults with invasive aspergillosis who can receive azole therapy and where they are considered an effective option.
- Patients with confirmed DCM involving extra-pulmonary sites with or without ongoing active disease in lungs, progressive or refractory, even in case of failure to azoles
- Patients with chronic, non-invasive aspergillosis syndromes without evidence of invasive disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Anti Fungal DrugNovel anti fungal medication in phase 2/3 development | Drug | – |
| Olorofim is a novel antifungal drugOlorofim (F903138) is a novel orotomide anti fungal medication | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2026.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A study testing Anti Fungal Drug and Olorofim is a novel antifungal drug, run by F2G Ltd.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Omar M Fernandez (+44 (0) 7443 147819, Omar.Marinfernandez@f2g.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2026.