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rhNGF
rhNGF is a Small molecule drug developed by Dompé Farmaceutici S.p.A. It is currently in Phase 2 development. Also known as: NGF, cenegermin.
Cenegermin, also known as recombinant human nerve growth factor, is a protein that acts as a neurotrophic tyrosine kinase receptor agonist. It is used to treat conditions such as Neurotrophic Keratitis, Dry Eye, and Persistent Corneal Epithelial Defect, and is sold under the brand name Oxervate.
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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 | rhNGF |
|---|---|
| Also known as | NGF, cenegermin |
| Sponsor | Dompé Farmaceutici S.p.A |
| Modality | Small molecule |
| Phase | Phase 2 |
Approved indications
Common side effects
Key clinical trials
- Efficacy and Safety of Intranasal Cenegermin in Adult Participants With Non-Arteritic Anterior Ischemic Optic Neuropathy (NAION) (PHASE3)
- A Safety and Efficacy Study of 2 Dosing Regimens of Recombinant Human Nerve Growth Factor (rhNGF) Eye Drop Solution Compared With Vehicle in Patients With Dry Eye Disease. (PHASE2)
- DEFENDO Long Term Follow-up Study in Stage 1 NK Patients
- Study to Evaluate Safety and Efficacy of Cenegermin (Oxervate®) vs Vehicle in Severe Sjogren's Dry Eye Disease (PHASE3)
- Study to Evaluate OXERVATE® in Patients With Stage 1 Neurotrophic Keratitis (PHASE4)
- Corneal Neurotization vs. Cenergermin for Neurotrophic Keratitis: A Pilot Study (NA)
- DOMPE -MT Neurotrophic Keratitis (PHASE4)
- Corneal Nerves After Treatment With Cenegermin
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:
- rhNGF CI brief — competitive landscape report
- rhNGF updates RSS · CI watch RSS
- Dompé Farmaceutici S.p.A portfolio CI
Frequently asked questions about rhNGF
What is rhNGF?
Who makes rhNGF?
Is rhNGF also known as anything else?
What development phase is rhNGF in?
Related
- Manufacturer: Dompé Farmaceutici S.p.A — full pipeline
- Also known as: NGF, cenegermin
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing