Drugs / Cenegermin
Cenegermin
Regulatory milestones approvals, filings & regulatory actions · 2 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Approved | US (FDA) | OXERVATE | — | 2018-08-22 | fda.gov ↗ |
| Approved | EU (EMA) | Oxervate | — | 2017-07-06 | europa.eu ↗ |
Trials 7
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial | ||||||
| Phase 1 | NCT05700864 | Nov 2022 → Dec 2023 | corneal disorder, neuropathy, painful | Tufts Medical Center | Withdrawn | No outcome recorded Stop: Business |
| Phase 34 trials | ||||||
| Phase 3 | NCT07453888 | Jul 2026 → Sep 2027 expected | non-arteritic anterior ischemic optic neuropathy | Dompé Farmaceutici S.p.A | Recruiting | No outcome recorded |
| Phase 3 | NCT07519902 | Jun 2026 → Dec 2027 expected | corneal disorder | Dompé Farmaceutici S.p.A | Recruiting | No outcome recorded |
| Phase 3 | NCT05136170 | Jan 2022 → May 2023 | dry eye syndrome | Dompé Farmaceutici S.p.A | Completed | Mixed |
| Phase 3 | NCT05133180 | Jan → Sep 2022 | dry eye syndrome | Dompé Farmaceutici S.p.A | Completed | Mixed |
| Phase 42 trials | ||||||
| Phase 4 | NCT06411145 | Apr → Nov 2024 | corneal ulcer, neurotrophic keratopathy | Dompé Farmaceutici S.p.A | Withdrawn | No outcome recorded Stop: Enrollment |
| Phase 4 | NCT04485546 | Sep 2020 → Sep 2021 | neurotrophic keratopathy | Dompé Farmaceutici S.p.A | Completed | No outcome recorded |
| Comparator or background therapy1 trial | ||||||
| Phase 4 | NCT06947850 Comparator | Jan 2023 → Sep 2025 overdue | dry eye syndrome, neurotrophic keratoconjunctivitis | Toyos Clinic | Active not recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 4
| Date | Issuer | Release |
|---|---|---|
| 2025-10-16 | Dompé Farmaceutici S.p.A | Regulatory Dompé's program in NAION selected for Landmark FDA Commissioner’s National Priority Voucher Program dompe.com ↗
Dompé intends to apply the voucher for the Biologic License Application (BLA) for an intranasally administered formulation of Nerve Growth Factor (Cenegermin-bkbj) for the treatment of non-arteritic anterior ischemic optic neuropathy (NAION). |
| 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. |
| 2017-07-10 | Dompé Farmaceutici S.p.A | Regulatory Cenegermin eye drops receive European Union approval: the first biotechnological drug resulting from Dompé research for the treatment of moderate to severe neurotrophic keratitis is Made in Italy dompe.com ↗
Dompé, an Italian biopharmaceutical company, announces that the European Commission has granted the marketing authorisation of cenegermin eye drops for the treatment of moderate to severe neurotrophic keratitis. |
| 2017-05-23 | Dompé Farmaceutici S.p.A | Regulatory Dompé receives positive CHMP opinion in Europe for Oxervate® dompe.com ↗
Today, the biopharmaceutical company Dompé has announced that the Committee for Human Medicinal Products (CHMP) of EMA (European Medicines Agency) has released a positive opinion, recommending the marketing authorization for Oxervate® (cenegermin eye drops), for the treatment of adult patients with moderate or severe neurotrophic keratitis. |
All press releases naming this drug 10 releases
Evidence & citations 8 cited values
Every value below carries the sentence it was read from. 9 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Cenegermin | “Oxervate®, an ophthalmic solution containing cenegermin 20 mcg/mL, which is a recombinant human Nerve Growth Factor (rhNGF); one drop of the test product will be instilled in...” NCT05133180 ↗ |
| Known as | cenegermin-bkbj | “Cenegermin-bkbj (20 mcg/mL) is an ophthalmic solution contained in a multiple-dose vial.” NCT06411145 ↗3“Oxervate (cenegermin-bkbj) is commonly used to treat neurotrophic keratitis” NCT06947850 ↗ |
| Known as | OXERVATE | “This prospective, single center, interventional, open-label, single arm, non-randomized trial seeks to investigate the efficacy of Oxervate® (cenergermin 0.002% eye drops) on...” NCT05700864 ↗3“Oxervate®, an ophthalmic solution containing cenegermin 20 mcg/mL, which is a recombinant human Nerve Growth Factor (rhNGF); one drop of the test product will be instilled in...” NCT05133180 ↗ “Cenegermin-bkbj, the active ingredient of OXERVATE® 0.002% (20 mcg/mL) cenegermin-bkbj ophthalmic solution” NCT06411145 ↗ “Cenegermin Ophthalmic Solution [Oxervate]” NCT06947850 ↗ |
| Known as | OXERVATE 0.002% (20 mcg/mL) cenegermin-bkbj ophthalmic solution | “OXERVATE® 0.002% (20 mcg/mL) cenegermin-bkbj ophthalmic solution” NCT04485546 ↗1“OXERVATE™ 0.002% (20 mcg/mL) cenegermin-bkbj ophthalmic solution” NCT05700864 ↗ |
| Known as | Recombinant Human Nerve Growth Factor | “Intranasal Cenegermin (Recombinant Human Nerve Growth Factor [rhNGF])” NCT07453888 ↗ |
| Known as | rhNGF | “Phase IV Multicenter, Prospective, Open-Label Clinical Trial of Cenegermin (rhNGF) for Stage 1 Neurotrophic Keratopathy (DEFENDO).” PMID 38175466 ↗ Jan 20242“where cenergermin-bkbj stands for Topical Recombinant Human Nerve Growth Factor (rhNGF).” NCT06411145 ↗ “Intranasal Cenegermin (Recombinant Human Nerve Growth Factor [rhNGF])” NCT07453888 ↗ |
| Modality | Protein / enzyme biologic | “recombinant human Nerve Growth Factor (rhNGF)” NCT05133180 ↗ |
| Route | Other | “one drop of the test product will be instilled in both eyes three times daily (TID)” NCT05133180 ↗ |