Last reviewed 2026-04-19 · How we verify

F901318 safety

F2G Biotech GmbH · Phase 1 active Small molecule

F901318 safety is a Small molecule drug developed by F2G Biotech GmbH. It is currently in Phase 1 development. Also known as: adverse events.

Likelihood of approval

9.6% vs 9.6% industry baseline

If approved by FDA: likely 2033–2036

Steps remaining: Phase 2 → Phase 3 → NDA/BLA submission

Confidence: Medium

Why this estimate

Baseline phase 1 → approval rate +9.6pp
Industry-wide phase 1 drugs reach approval ~9.6% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).

Predicted approval windows by jurisdiction (conditional on FDA approval)

Regulator	Country	Likely year	Lag vs FDA
FDA	US	2033–2036	—
EMA	EU	2034–2037	+0.7 yr
MHRA	GB	2034–2037	+0.7 yr
Health Canada	CA	2034–2038	+0.9 yr
TGA	AU	2034–2038	+1.2 yr
PMDA	JP	2034–2038	+1.5 yr
NMPA	CN	2035–2039	+2.3 yr
MFDS	KR	2034–2038	+1.4 yr
CDSCO	IN	2034–2039	+1.8 yr
ANVISA	BR	2035–2039	+2.3 yr

Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).

Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.

At a glance

Generic name	F901318 safety
Also known as	adverse events
Sponsor	F2G Biotech GmbH
Modality	Small molecule
Phase	Phase 1

Approved indications

No approved indications tracked.

Common side effects

No common side effects on file.

Key clinical trials

Olorofim Aspergillus Infection Study (PHASE3)
A Biopharmaceutics Study to Assess the Pharmacokinetics of Single Oral and IV Doses of Olorofim (PHASE1)
Assessment of Varying Oral Dosing Regimens for F901318 in Healthy Subjects (PHASE1)
Safety and Pharmacokinetics of Oral F901318 (Fluconazole and Posaconazole) IN Aml Leukaemia (PHASE1, PHASE2)
Study on Safety and Pharmacokinetics of Intravenous F901318 for Fungal Prophylaxis in AML Patients (PHASE1, PHASE2)
Pharmacokinetics of IV Formulation (PHASE1)
Multiple Ascending Oral Dose Study of F901318 in Healthy Subjects (PHASE1)
F901318 Multiple Ascending Dose Study (PHASE1)

Primary sources

Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.

Source	Used for
ClinicalTrials.gov	Trial enrolment, design, endpoints, results

Competitive intelligence

For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:

F901318 safety CI brief — competitive landscape report
F901318 safety updates RSS · CI watch RSS
F2G Biotech GmbH portfolio CI

Frequently asked questions about F901318 safety

What is F901318 safety?

F901318 safety is a Small molecule drug developed by F2G Biotech GmbH.

Who makes F901318 safety?

F901318 safety is developed by F2G Biotech GmbH (see full F2G Biotech GmbH pipeline at /company/f2g-biotech-gmbh).

Is F901318 safety also known as anything else?

F901318 safety is also known as adverse events.

What development phase is F901318 safety in?

F901318 safety is in Phase 1.

Manufacturer: F2G Biotech GmbH — full pipeline
Also known as: adverse events

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing