16 and older, any sex, with Invasive Fungal Infections. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Data Review Committee (DRC) Adjudicated Overall Response at Day 42Primary· Day 42 in the Main Phase of study treatment
The primary efficacy variable was the DRC-adjudicated overall response at the Day 42 Study Visit, as determined by an independent DRC using a combination of clinical, mycological, and radiological results based on European Organization for Research and Treatment of Cancer/Invasive Fungal Infections Cooperative Group and the National Institute of Allergy and Infectious Diseases Mycoses Study Group (EORTC/MSG) criteria. For the primary statistical analysis of overall response rate, values were assigned to the DRC adjudicated overall response as follows: Success (Success-Complete, Success-Partial
Group
Value
95% CI
Olorofim (F901318)
28.7
22.6 – 35.5
DRC Adjudicated Overall Response at Day 42 for All AspergillusSecondary· Day 42 in the Main Phase of study treatment
The primary efficacy variable was the DRC-adjudicated overall response at the Day 42 Study Visit, as determined by an independent DRC using a combination of clinical, mycological, and radiological results based on EORTC/MSG criteria. This was also presented by each of the 5 major infections as adjudicated by the DRC at baseline. The Aspergillus- All category is a combination of participants with Aspergillus proven and Aspergillus probable (invasive aspergillosis lower respiratory tract disease) baseline disease category. Overall success is defined as a Complete or Partial Response.
Group
Value
95% CI
Olorofim (F901318)
34.7
25.5 – 44.8
DRC Adjudicated Overall Response at Day 42 for Lomentospora ProlificansSecondary· Day 42 in the Main Phase of study treatment Day 42 in the Main Phase of study treatment Day 42 in the Main Phase of study treatment Day 42 in the Main Phase of study treatment Day 42 in the Main Phase of study treatment
The primary efficacy variable was the DRC-adjudicated overall response at the Day 42 Study Visit, as determined by an independent Data Review Committee using a combination of clinical, mycological, and radiological results based on EORTC/MSG criteria. This was also presented by each of the 5 major infections as adjudicated by the DRC at baseline, this one is for participants with a proven infection due to Lomentospora prolificans. Success is defined as a Complete or Partial Response.
Group
Value
95% CI
Olorofim (F901318)
42.3
23.4 – 63.1
DRC Adjudicated Overall Response at Day 42 for for Scedosporium SpeciesSecondary· Day 42 in the Main Phase of study treatment
The primary efficacy variable was the DRC-adjudicated overall response at the Day 42 Study Visit, as determined by an independent DRC using a combination of clinical, mycological, and radiological results based on EORTC/MSG criteria. This was also presented by each of the 5 major infections as adjudicated by the DRC at baseline, this one is for participants with a proven infection due to Scedosporium species. Success is defined as a Complete or Partial Response.
Group
Value
95% CI
Olorofim (F901318)
36.4
17.2 – 59.3
DRC Adjudicated Overall Response at Day 42 for Coccidioides SpeciesSecondary· Day 42 in the Main Phase of study treatment
The primary efficacy variable was the DRC-adjudicated overall response at the Day 42 Study Visit, as determined by an independent DRC using a combination of clinical, mycological, and radiological results based on EORTC/MSG criteria. This was also presented by each of the 5 major infections as adjudicated by the DRC at baseline, this one is for participants with proven infection due to Coccidioides species. Success is defined as a Complete or Partial Response.
Group
Value
95% CI
Olorofim (F901318)
0.0
0.0 – 8.6
DRC Adjudicated Overall Response at Day 42 for Other Olorofim Susceptible FungiSecondary· Day 42 in the Main Phase of study treatment
The primary efficacy variable was the DRC-adjudicated overall response at the Day 42 Study Visit, as determined by an independent DRC using a combination of clinical, mycological, and radiological results based on EORTC/MSG criteria. This was also presented by each of the 5 major infections as adjudicated by the DRC at baseline, this one is for participants with proven infection due to other olorofim susceptible fungi. Success is defined as a Complete or Partial Response.
Group
Value
95% CI
Olorofim (F901318)
33.3
9.9 – 65.1
DRC Adjudicated Overall Response at Day 84Secondary· Day 84 in the Main Phase of study treatment
DRC-adjudicated overall response at Day 84, as determined by an independent DRC using a combination of clinical, mycological, and radiological results based on the EORTC/MSG criteria. For the analysis of overall response rate, values were assigned to the DRC-adjudicated overall response as follows: Success (Success-Complete, Success-Partial); Failure (Failure-Stable, Failure-Progression, Death, and participants for whom data at the Study Visit could not be collected or participants who were considered not evaluable at the Study Visit).
Group
Value
95% CI
Olorofim (F901318)
27.2
21.2 – 33.9
Investigator Assessed Overall Response at Day 42Secondary· Day 42 in the Main Phase of study treatment
Investigator-assessed overall response (as determined by the Investigator using all available assessment results including clinical, mycological and radiologic results based on the EORTC/MSG criteria) at Day 42, categorised by the same response criteria as in the primary endpoint: Success (Success-Complete, Success-Partial), Failure (Failure-Stable, Failure-Progression, Death, participants for whom data at Day 42 could not be collected or who were considered not evaluable at the specific visit).
Group
Value
95% CI
Olorofim (F901318)
24.8
19.0 – 31.3
Investigator Assessed Overall Response at Day 84Secondary· Day 84 in the Main Phase of study treatment
Investigator-assessed overall response (as determined by the Investigator using all available assessment results including clinical, mycological and radiologic results based on the EORTC/MSG criteria) at Day 84, categorised by the same response criteria as in the primary endpoint: Success (Success-Complete, Success-Partial), Failure (Failure-Stable, Failure-Progression, Death, participants for whom data at Day 84 could not be collected or who were considered not evaluable at the specific visit).
Group
Value
95% CI
Olorofim (F901318)
29.7
23.5 – 36.5
DRC Adjudicated Clinical Response at Day 42Secondary· Day 42 in the Main phase of study treatment
DRC adjudicated clinical response at the Day 42 Study Visit, as determined by an independent Data Review Committee using clinical response results based on EORTC/MSG criteria. Resolution is defined as a Complete or Partial Response.
Group
Value
95% CI
Olorofim (F901318)
59.9
52.8 – 66.7
DRC Adjudicated Clinical Response at Day 84Secondary· Day 84 in the Main phase of study treatment
DRC adjudicated clinical response at the Day 84 Study Visit, as determined by an independent DRC using clinical response results based on EORTC/MSG criteria. Resolution is defined as a Complete or Partial Response.
Group
Value
95% CI
Olorofim (F901318)
54.0
46.8 – 61.0
Investigator Assessed Clinical Response at Day 42Secondary· Day 42 in the Main phase of study treatment
Investigator assessed clinical response at the Day 42 Study Visit using clinical response results based on the EORTC/MSG criteria. Resolution is defined as a Complete or Partial Response.
Group
Value
95% CI
Olorofim (F901318)
53.5
46.3 – 60.5
Adverse events — posted to ClinicalTrials.gov
Time frame: Adverse events (AEs) were reported from the time of Informed consent through study completion, up to and including 4-week post-treatment follow-up. For patients in the main treatment phase of the study only, the median duration of study treatment was 84 days. For those entering the extended treatment phase, the median duration of study treatment was 308 days (approximately 10 months)..
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Olorofim (F901318)
Serious: 132/203 (65%)
Deaths: 50/203
Serious adverse events (194 terms)
Reaction
System
Olorofim (F901318)
Pneumonia
Infections and infestations
—
Pyrexia
General disorders
—
COVID-19
Infections and infestations
—
Respiratory failure
Respiratory, thoracic and mediastinal disorders
—
Hepatic enzyme increased
Investigations
—
Liver function test increased
Investigations
—
Dyspnoea
Respiratory, thoracic and mediastinal disorders
—
Meningitis coccidioides
Infections and infestations
—
Acute respiratory failure
Respiratory, thoracic and mediastinal disorders
—
Aspergillus infection
Infections and infestations
—
Seizure
Nervous system disorders
—
Septic shock
Infections and infestations
—
Acute kidney injury
Renal and urinary disorders
—
Acute myeloid leukaemia refractory
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
—
Atrial fibrillation
Cardiac disorders
—
Headache
Nervous system disorders
—
Hydrocephalus
Nervous system disorders
—
Pneumonia viral
Infections and infestations
—
Pulmonary embolism
Respiratory, thoracic and mediastinal disorders
—
Neutropenia
Blood and lymphatic system disorders
—
Abdominal pain
Gastrointestinal disorders
—
Acute myeloid leukaemia
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Publications: Europe PMC API search by NCT ID, retrieved 9 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by F2G Biotech GmbH
Last refreshed: 10 July 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03583164.