Cenegermin clinical trials
Cenegermin is named as an intervention in 2 current clinical trials in our UK, USA, South Korea, Australia, Germany, France, Spain, Italy, Netherlands, Poland, Czechia, Mexico and Japan registers. 2 are recruiting patients now. All registered phases are Phase 3. The lead sponsor is Dompé Farmaceutici S.p.A. The most-studied condition is Non-Arteritic Anterior Ischemic Optic Neuropathy. The EU clinical trials register (CTIS) separately lists 2 authorised or ongoing trials.
Where Cenegermin is approved
All regulators →Of the three regulators tracked here, the first to approve Cenegermin was the EU, on 6 Jul 2017. It is approved in 3 of the 3 regulators tracked here.
From the regulators' own registers: FDA Drugs@FDA, the EMA medicines list and Health Canada's Notice of Compliance database. Dates are the first listed approval of a product containing only this substance; combination products and nationally authorised EU medicines are not counted.
Cenegermin patents and exclusivity
Expiry tracker →Protections still running for marketed products containing Cenegermin, as listed by the regulators. Expired patents and exclusivities, and discontinued products, are not shown.
- OXERVATE for treatment of neurotrophic keratitis: until 10 Jul 2027. Union Register
Reproduced from the FDA Orange Book and Purple Book (checked 8 Nov 2026) and the European Commission's Union Register of medicinal products (CC BY 4.0; the EU expiry date is calculated exactly as the Commission's register displays it). Listed patents and dates are as submitted to or published by the regulator and may not reflect litigation, invalidation, settlements, lapsed fees or later extensions. This is not legal advice or a freedom-to-operate opinion, and it does not say when a generic or biosimilar will launch.
What health systems spend on Cenegermin
All medicines →From NHSBSA Prescription Cost Analysis (Open Government Licence v3.0) and CMS State Drug Utilization Data. Both are gross amounts: neither system publishes its discounts or rebates per drug. Products combining several substances are not counted here.
How Cenegermin works
All drug targets →- Neurotrophic tyrosine kinase receptor agonist AgonistTarget: Neurotrophic tyrosine kinase receptorChEMBL only
- Dry eye syndromePhase 2
- Sensory peripheral neuropathyPhase 2
- Retinitis pigmentosaPhase 1/2
- Hereditary optic neuropathyPhase 1
- Open-angle glaucomaPhase 1
Mechanisms and diseases from ChEMBL via the Open Targets Platform (release 26.09), ChEMBL record CHEMBL4297852, CC BY-SA 3.0. Targets checked against the IUPHAR/BPS Guide to PHARMACOLOGY (2026.3.1), ligand 5026, CC BY-SA 4.0. Trial phases are not approvals: approved uses are shown from the regulators' own records where we hold them.
NICE appraisals of Cenegermin
All NICE appraisals →NICE, which decides whether the NHS in England should fund new medicines, has published 1 technology appraisal of Cenegermin. 1 is current.
| Appraisal | NICE recommendation | Published | Status |
|---|---|---|---|
| Cenegermin for treating neurotrophic keratitis NICE TA532 | Not recommended | 18 Jul 2018 | Current |
NICE decisions apply to the NHS in England. In Ireland the HSE decides on reimbursement, advised by the National Centre for Pharmacoeconomics. Titles, categories and dates link to the guidance on nice.org.uk. © NICE 2026 technology appraisal guidance. Available from www.nice.org.uk/guidance. All rights reserved. Subject to Notice of rights. NICE guidance is prepared for the National Health Service in England. All NICE guidance is subject to regular review and may be updated or withdrawn. NICE accepts no responsibility for the use of its content in this product/publication.
Patient leaflets for Cenegermin
The package leaflet is the official guide for patients that comes with every medicine. These links go to the regulators that publish it.
- EUEuropean Union: OxervateEMA product information: package leaflet and summary of product characteristics in every EU language.
- UKUnited Kingdom: Search MHRA ProductsPatient information leaflets and SmPCs for UK-licensed products.
- USUnited States: Search DailyMedFDA-approved labels, including patient and medication guides.
Leaflets differ between brands and countries; always read the one that comes with your own medicine. This is regulatory information, not medical advice.
Trials by status
Trials by phase
Clinical trials of Cenegermin
2 trials| Study | Phase | Status | Lead sponsor | Registers |
|---|---|---|---|---|
|
Efficacy and Safety of Intranasal Cenegermin in Adult Participants With Non-Arteritic Anterior Ischemic Optic Neuropathy (NAION)
NCT07453888 · Non-Arteritic Anterior Ischemic Optic Neuropathy
|
Phase 3 | Recruiting | Dompé Farmaceutici S.p.A | UK, USA, South Korea, Australia |
|
An Efficacy and Safety Study of Cenegermin Ophthalmic Solution Compared With Vehicle in the Treatment of PCED
NCT07519902 · Persistent Corneal Epithelial Defect
|
Phase 3 | Recruiting | Dompé Farmaceutici S.p.A | UK, USA, Germany, France, Spain, Italy, Netherlands, Poland, Czechia, Mexico, Japan, South Korea |
Registers list studies that are recruiting, about to open, active but closed to enrolment, or enrolling by invitation. The UK and USA registers cover industry-sponsored studies only. Trial titles and statuses are copied from the registry as published.
Cenegermin in the EU trials register (CTIS)
2 trialsAuthorised or ongoing trials in the EU Clinical Trials Information System that list a product containing Cenegermin. Many trials are registered in both CTIS and ClinicalTrials.gov, so these are shown separately rather than added to the count above. Trials with a site in Ireland are listed first.
| Study | Phase | Status | Sponsor | Countries |
|---|---|---|---|---|
|
Randomized, Multicenter, Vehicle-Controlled, Double-Masked Study to Evaluate the Efficacy and Safety of Intranasal Cenegermin (Recombinant Human Nerve Growth Factor [rhNGF]) in Adult Participants with Non-Arteritic Anterior Ischemic Optic Neuropathy (NAION)
2025-524748-37-00 · Eye Diseases
|
Phase 2 | Authorised | Dompe' Farmaceutici S.p.A | Denmark, Italy, Germany + 6 more |
|
Randomized, Double-Blinded, Vehicle-Controlled, Parallel Group, Adaptive Proof-of-concept, Dose-selecting Phase 2a Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Efficacy of Intranasal Cenegermin (recombinant human Nerve Growth Factor [rhNGF]) in Adult Participants with subacute moderate to severe Traumatic Brain Injury (TBI).
2025-522692-29-00 · CTIS ↗ · Nervous System Diseases
|
Phase 2 | Ongoing | Dompe' Farmaceutici S.p.A | Italy, Denmark, Finland + 5 more |
Conditions studied with Cenegermin
2 conditionsSponsors
lead sponsor per trial| Lead sponsor | Trials |
|---|---|
| Dompé Farmaceutici S.p.A | 2 |
By country register
A trial with sites in more than one country appears in each of those registers. CTIS does not publish a recruiting flag; its trials may also appear in the registers above.
Questions about Cenegermin trials
How many clinical trials are testing Cenegermin?
2 current trials in our UK, USA, South Korea, Australia, Germany, France, Spain, Italy, Netherlands, Poland, Czechia, Mexico and Japan registers name Cenegermin as a drug or biological intervention, as of the registry sync on 9 November 2026. Completed and withdrawn studies are not counted.
Are Cenegermin trials recruiting patients?
Yes. 2 of the 2 trials are recruiting: 2 with sites in UK, 2 with sites in USA, 2 with sites in South Korea, 1 with sites in Australia, 1 with sites in Germany, 1 with sites in France, 1 with sites in Spain, 1 with sites in Italy, 1 with sites in Netherlands, 1 with sites in Poland, 1 with sites in Czechia, 1 with sites in Mexico and 1 with sites in Japan. Eligibility and site contacts are on each trial's record. Only the study team can confirm whether a patient is eligible.
Who sponsors Cenegermin clinical trials?
The lead sponsor is Dompé Farmaceutici S.p.A. The number in brackets is how many trials each organisation leads.
Where does this information come from?
Every trial, status, phase and sponsor on this page is copied from public ClinicalTrials.gov records by a daily sync. Nothing here describes how Cenegermin works or whether it is effective, and it is not medical advice.
How this page is built
Everything on this page is copied from public ClinicalTrials.gov registry records — it is not written from memory, and nothing here describes how Cenegermin works or whether it is effective. Each trial links to its own record so you can check it yourself.
- ClinicalTrials.gov (U.S. National Library of Medicine) ↗ Trial IDs, titles, intervention names and synonyms, phase, overall status, lead sponsor and conditions for every trial on this page
This page is built automatically: a daily sync job reads the registry records behind our country trial registers, collects every trial that lists Cenegermin (or a registered synonym) as a drug or biological intervention, and tabulates the registry fields directly. Placebos and generic comparators are excluded. There is no AI drafting and no per-compound editorial pass, and the page has not been clinically reviewed. The “last verified” date above is the timestamp of that sync, not a review date. Our general editorial approach is described in our editorial standards and corrections policy. The ClinicalTrials.gov data on this page was last retrieved on 9 Nov 2026. How every register is built: methodology · fixes we have made: corrections log.