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FOV1101-00
FOV1101-00 is a Small molecule drug developed by Fovea Pharmaceuticals SA. It is currently in Phase 2 development for Inherited retinal dystrophies, Age-related macular degeneration.
FOV1101-00 is a small molecule that targets retinal degeneration through modulation of cellular survival pathways in the eye.
FOV1101-00 is a small molecule that targets retinal degeneration through modulation of cellular survival pathways in the eye. Used for Inherited retinal dystrophies, Age-related macular degeneration.
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Baseline phase 2 → approval rate
+15.3pp
Industry-wide phase 2 drugs reach approval ~15.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2031–2034 | — |
| EMA | EU | 2032–2035 | +0.7 yr |
| MHRA | GB | 2032–2035 | +0.7 yr |
| Health Canada | CA | 2032–2036 | +0.9 yr |
| TGA | AU | 2032–2036 | +1.2 yr |
| PMDA | JP | 2032–2036 | +1.5 yr |
| NMPA | CN | 2033–2037 | +2.3 yr |
| MFDS | KR | 2032–2036 | +1.4 yr |
| CDSCO | IN | 2032–2037 | +1.8 yr |
| ANVISA | BR | 2033–2037 | +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 | FOV1101-00 |
|---|---|
| Sponsor | Fovea Pharmaceuticals SA |
| Modality | Small molecule |
| Therapeutic area | Ophthalmology |
| Phase | Phase 2 |
Mechanism of action
Fovea Pharmaceuticals' FOV1101-00 is designed to address inherited retinal dystrophies and age-related macular degeneration by promoting photoreceptor cell survival and function. The drug works through intracellular signaling modulation to protect against photoreceptor degeneration. The exact molecular target and detailed mechanism remain proprietary, but the approach focuses on neuroprotection in the retina.
Approved indications
- Inherited retinal dystrophies
- Age-related macular degeneration
Common side effects
Key clinical trials
- Study Evaluating the Efficacy of Administration of Cyclosporine (Low Dose and High Dose) and Prednisolone Acetate Compared to Its Components and Vehicle in Patients With Allergic Conjunctivitis (PHASE2)
- Evaluation of Efficacy of Coadministration of FOV1101-00 and Prednisolone Acetate in Patients With Mild Ongoing Ocular Allergic Inflammation (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:
- FOV1101-00 CI brief — competitive landscape report
- FOV1101-00 updates RSS · CI watch RSS
- Fovea Pharmaceuticals SA portfolio CI
Frequently asked questions about FOV1101-00
What is FOV1101-00?
How does FOV1101-00 work?
What is FOV1101-00 used for?
Who makes FOV1101-00?
What development phase is FOV1101-00 in?
Related
- Manufacturer: Fovea Pharmaceuticals SA — full pipeline
- Therapeutic area: All drugs in Ophthalmology
- Indication: Drugs for Inherited retinal dystrophies
- Indication: Drugs for Age-related macular degeneration
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing