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Flotufolastat F18
Flotufolastat F18 is a small molecule that targets the SARS-CoV-2 main protease.
Flotufolastat F18 is a small molecule that targets the SARS-CoV-2 main protease. Used for Treatment of COVID-19.
At a glance
| Generic name | Flotufolastat F18 |
|---|---|
| Also known as | POSLUMA® |
| Sponsor | Icahn School of Medicine at Mount Sinai |
| Drug class | SARS-CoV-2 main protease inhibitor |
| Target | SARS-CoV-2 main protease |
| Modality | Small molecule |
| Therapeutic area | Infectious Disease |
| Phase | Phase 2 |
Mechanism of action
Flotufolastat F18 works by inhibiting the SARS-CoV-2 main protease, which is essential for the viral replication. This inhibition prevents the virus from replicating and spreading within the host. By targeting this specific enzyme, Flotufolastat F18 aims to reduce the viral load and alleviate symptoms in patients infected with COVID-19.
Approved indications
- Treatment of COVID-19
Common side effects
- Nausea
- Headache
- Diarrhea
Key clinical trials
- Androgen Deprivation Therapy (Relugolix) for the Improvement of Diagnostic Imaging (PSMA PET/CT Scan) in Patients With High Risk or Very High Risk Prostate Cancer, The EnrichPSMA Trial (PHASE2)
- Comparing a New PSMA Imaging Agent to MRI for Detecting Prostate Cancer, BEACON Trial (EARLY_PHASE1)
- Diagnostic Utility of rhPSMA-7.3 (18F) PET/CT in Men With Prostate Cancer on Active Surveillance (PHASE2)
- Study to Assess [177Lu]Lu-PSMA-R2 (AAA602) and [225Ac]Ac-PSMA-R2 (AAA802) in Participants With PSMA-positive HRLPC (PHASE1, PHASE2)
- Radioligand Therapy After PSMA PET Guided External Beam Radiotherapy for Treating Post-Prostatectomy Patients With Biochemically Recurrent Prostate Cancer (PHASE1)
- Flotufolastat F 18 PET in Men With Very Low PSA Recurrence
- An Investigational Scan (Flotufolastat F 18 PET/CT) for Detecting Residual or Recurrent Disease in Patients Who Completed Focal Therapy for Prostate Cancer. (PHASE2)
- POSLUMA® (18F-rhPSMA-7.3) PET-CT for PIRADS 2/3 Lesions (PHASE2)
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:
- Flotufolastat F18 CI brief — competitive landscape report
- Flotufolastat F18 updates RSS · CI watch RSS
- Icahn School of Medicine at Mount Sinai portfolio CI