Drugs / rhNGF
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Approved | EU (EMA) | Oxervate | — | 2017-07-06 | europa.eu ↗ |
Trials 12
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 14 trials | ||||||
| Phase 1 | NCT04232332 | Dec 2019 → Dec 2021 | optic nerve disorder | Beijing Tongren Hospital | Unknown | No outcome recorded |
| Phase 1 | NCT03836859 | Mar → Jun 2018 | — | Dompé Farmaceutici S.p.A | Completed | No outcome recorded |
| Phase 1 | NCT02855450 | Dec 2016 → May 2018 | glaucoma | Dompé Farmaceutici S.p.A | Completed | No outcome recorded |
| Phase 1 | NCT01744704 | Jul 2012 → Feb 2013 | — | Dompé Farmaceutici S.p.A | Completed | No outcome recorded |
| Phase 1/22 trials · 1 met primary | ||||||
| Phase 1/2 | NCT02110225 | Jan 2014 → Nov 2015 | retinitis pigmentosa | Dompé Farmaceutici S.p.A | Completed | No outcome recorded |
| Phase 1/2 | NCT01756456 | Jan 2013 → Apr 2015 | corneal ulcer, neurotrophic keratopathy | Dompé Farmaceutici S.p.A | Completed | Met primary |
| Phase 26 trials · 2 met primary · 3 missed | ||||||
| Phase 2 | NCT06244316 | Jan → Dec 2024 | dry eye syndrome | Dompé Farmaceutici S.p.A | Completed | Met primary |
| Phase 2 | NCT03982368 | Jun 2019 → Jul 2020 | dry eye syndrome | Dompé Farmaceutici S.p.A | Completed | Missed primary |
| Phase 2 | NCT03019627 | Jan → Aug 2017 | dry eye syndrome | Dompé Farmaceutici S.p.A | Completed | Missed primary |
| Phase 2 | NCT03035864 | Jan → Sep 2017 | asthenopia | Dompé Farmaceutici S.p.A | Completed | Missed primary |
| Phase 2 | NCT02227147 | Feb 2015 → Jun 2016 | neurotrophic keratopathy | Dompé Farmaceutici S.p.A | Completed | Met primary |
| Phase 2 | NCT02101281 | Jan 2014 → Jan 2015 | dry eye syndrome | Dompé Farmaceutici S.p.A | Completed | No outcome recorded |
| Comparator or background therapy1 trial | ||||||
| Phase 2 | NCT02609165 Comparator | May 2015 → Feb 2017 | cystoid macular edema, retinitis pigmentosa | Ospedale San Raffaele | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 1
| Date | Issuer | Release |
|---|---|---|
| 2018-08-22 | Dompé Farmaceutici S.p.A | Regulatory Dompé receives FDA approval cenegermin eye drops, first-in-class recombinant human nerve growth factor with potential to completely heal rare neurotrophic keratitis dompe.com ↗
Dompé today announced that the U.S. Food and Drug Administration (FDA) has approved cenegermin, a breakthrough therapy for neurotrophic keratitis (NK), a rare and progressive eye disease that can lead to corneal scarring and vision loss. |
All press releases naming this drug 1 release
| Date | Issuer | Release |
|---|---|---|
| 2018-08-22 | Dompé Farmaceutici S.p.A | Dompé receives FDA approval cenegermin eye drops, first-in-class recombinant human nerve growth factor with potential to completely heal rare neurotrophic keratitis dompe.com ↗ |
Evidence & citations 4 cited values
Every value below carries the sentence it was read from. 14 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | rhNGF | “Recombinant Human Nerve Growth Factor (rhNGF) eye drops at 20 μg/ml concentration administered six times daily for 8 weeks in patients with dry eye.” NCT03019627 ↗ |
| Known as | Recombinant Human Nerve Growth Factor | “Recombinant Human Nerve Growth Factor 180μg/ml (one 35 μl drop equals to 6.30 μg of rhNGF) reconstituted solution three times a day (TID) for 8 weeks of treatment.” NCT02855450 ↗4“Recombinant Human Nerve Growth Factor (rhNGF) eye drops at 20 μg/ml concentration administered six times daily for 8 weeks in patients with dry eye.” NCT03019627 ↗ “recombinant human nerve growth factor (rhNGF) eye drops solution” NCT01756456 ↗ “recombinant human nerve growth factor (rhNGF) eye drops solution” NCT02110225 ↗ |
| Modality | Protein / enzyme biologic | “a novel human recombinant NGF (rhNGF) eye-drop formulation” PMID 24327173 ↗ Jun 2014 |
| Route | Other | “rhNGF eye drops” NCT01744704 ↗ |