cenegermin-bkbj
Trade name: oxervate
Approved
Aug 22, 2018
Nerve growth factor (NGF) is a neurotrophic factor and neuropeptide primarily involved in the regulation of growth, maintenance, proliferation, and survival of certain target neurons. It is perhaps the prototypical growth factor, in that it was one of the first to be described. Since it was first isolated by Nobel laureates Rita Levi-Montalcini and Stanley Cohen in 1954, numerous biological processes involving NGF have been identified, two of them being the survival of pancreatic beta cells and the regulation of the immune system. — Wikipedia
Clinical trial activity
49 trials · 52 clinical orgs · 1 marketing orgs
Earliest trial started Nov 2, 1999 (NCT00000842)
Timeline
1990s
- Jan 1, 1999
Earliest Phase 2 Sponsor(trial)
2010s
- Jun 23, 2014
Orphan Drug Designation
- Aug 22, 2018
Dompe Pharmaceuticals — Earliest FDA Approval
- Aug 22, 2018
Dompe Pharmaceuticals — Marketing Organization
- Aug 22, 2018
Dompe Pharmaceuticals — NDA Organization
Indications
Approved for
Studied for
- Alzheimer Disease · Phase 4
- Amyotrophic Lateral Sclerosis · Phase 2/Phase 3
- Brain Injuries · Phase 2
- Brain Injuries, Traumatic · Phase 4
- Cerebral Palsy · Phase 2
- Cerebral Small Vessel Diseases · Phase 4
- Corneal Diseases · Phase 4
- Corneal Ulcer · Phase 4
- Deglutition Disorders · Phase 4
- Dementia, Vascular · Phase 4
- Diabetes Mellitus · Phase 1/Phase 2
- Dry Eye Syndromes · Phase 4
- Glaucoma · Phase 1
- Glioma · Phase 2
- Healthy Volunteers · Phase 1
- HIV Infections · Phase 2
- Hyperalgesia · Early Phase 1
- Ischemic Stroke · Phase 4
- Keratitis · Phase 4
- Macular Edema · Phase 2
- Mental Disorders · Phase 2
- Optic Nerve · Phase 1
- Pain · Early Phase 1
- Peripheral Nerve Injuries · Phase 1
- Peripheral Nervous System Diseases · Phase 2
- Retinitis Pigmentosa · Phase 2
- Speech Disorders · Phase 2
- Stroke · Phase 4
- Vision, Ocular · Phase 2
Mechanism of action
NTRK1 agonist
Neurotrophic tyrosine kinase receptor agonist
Acts through nerve growth factor receptors in the eye to support nerve integrity.
Approval history
- approvedPriority reviewFast trackBreakthroughAug 22, 2018
Chemistry & pharmacology
- Chirality
- Single Stereoisomer
- Inorganic
- No
- Polymer
- No
- Multi-specific
- No
Oral
No
Parenteral
No
Topical
No
Sources
- WikipediaNerve growth factor ↗
- NCATSB6E7K36KT8 ↗
- ChEMBLCHEMBL4297852 ↗
- ChEMBLCHEMBL4297796 ↗
- WikipediaCenegermin ↗
Also known as
- cenegermin-bkbj
- human nerve growth factor
- nerve growth factor
- nerve growth factor
- recombinant human nerve growth factor (rhngf)
Clinical trials
| NCT ID | Phase | Start date | Sponsor(s) |
|---|---|---|---|
| NCT07163182 | Phase 1 | Sep 15, 2025 | Chiesi, Comac Medical |
| NCT07073729 | N/A | Aug 1, 2025 | London Health Sciences Centre |
| NCT06737549 | Phase 4 | Dec 31, 2024 | Zhejiang University |
| NCT06391645 | Phase 2/Phase 3 (Phase 3) | May 31, 2024 | Capital Medical University |
| NCT06411145 | Phase 4 | Apr 26, 2024 | Dompe Pharmaceuticals |
| NCT06244316 | Phase 2 | Jan 22, 2024 | Dompe Pharmaceuticals |
| NCT05733572 | Phase 2 | Jun 12, 2023 | Catholic University of Sacred Heart, Rome |
| NCT06947850 | Phase 4 | Jan 21, 2023 | Toyos Clinic |
| NCT05700864 | Phase 1 | Nov 1, 2022 | Dompe Pharmaceuticals, Tufts University |
| NCT05231694 | Phase 4 | Apr 1, 2022 | Ningbo No. 2 Hospital, Zhejiang University |
| NCT05652751 | N/A | Mar 1, 2022 | Zhejiang University |
| NCT05136170 | Phase 3 | Dec 31, 2021 | Dompe Pharmaceuticals |
| NCT05133180 | Phase 3 | Nov 30, 2021 | Dompe Pharmaceuticals |
| NCT04485546 | Phase 4 | Sep 9, 2020 | Dompe Pharmaceuticals |
| NCT04232332 | Phase 1 | Dec 26, 2019 | Capital Medical University |
| NCT04041349 | Phase 4 | Aug 31, 2019 | Dongguan Houjie Hospital, Guangdong Pharmaceutical University, Guangzhou Medical University, Jinan University, Shantou University, Southern Medical University, Sun Yat-Sen University, Wuhan University |
| NCT03968042 | Phase 2 | Jun 30, 2019 | Sun Yat-Sen University |
| NCT03982368 | Phase 2 | Jun 10, 2019 | Dompe Pharmaceuticals |
| NCT03844243 | Early Phase 1 (Phase 1) | Feb 18, 2019 | Aalborg University |
| NCT03848247 | N/A | Jan 21, 2019 | Aalborg University |
Organizations
Research & Development (52)
| Organization | Org type | Trials | As lead sponsor | Phases | Earliest year |
|---|---|---|---|---|---|
| Dompe Pharmaceuticals | For profit | 17 | 15 | 4 | 2012 |
| Ever Neuro Pharma GmbH | For profit | 7 | 5 | 2 | 2005 |
| Aalborg University | Academic/Hospital | 5 | 5 | 2 | 2017 |
| Zhejiang University | Academic/Hospital | 3 | 3 | 2 | 2022 |
| Capital Medical University | Academic/Hospital | 2 | 2 | 2 | 2019 |
| Chiesi | For profit | 2 | 2 | 2 | 2018 |
| Comac Medical | For profit | 2 | 0 | 2 | 2018 |
| Cromsource | For profit | 2 | 0 | 1 | 2016 |
| Jinlin University | Academic/Hospital | 2 | 2 | 2 | 2010 |
| Sun Yat-Sen University | Academic/Hospital | 2 | 1 | 2 | 2019 |
| acromion GmbH | For profit | 1 | 0 | 1 | 2006 |
| Ain Shams University | Academic/Hospital | 1 | 1 | 1 | 2014 |
| Catholic University of Sacred Heart, Rome | Academic/Hospital | 1 | 1 | 1 | 2023 |
| Central Institute of Mental Health, Mannheim | Academic/Hospital | 1 | 1 | 1 | 2014 |
| City University of Hong Kong | Academic/Hospital | 1 | 0 | 1 | 2013 |
| Clinical Institute of the Brain, Russia | Academic/Hospital | 1 | 1 | 1 | 2011 |
| Covance | For profit | 1 | 0 | 1 | 2012 |
| Cross Research S.A. | For profit | 1 | 0 | 1 | 2014 |
| Dongguan Houjie Hospital | Academic/Hospital | 1 | 0 | 1 | 2019 |
| EBEWE Pharma | For profit | 1 | 0 | 1 | 2006 |
Marketing (2)
| Organization | Org type | Relationship | Date |
|---|---|---|---|
| Dompe Pharmaceuticals | For profit | MKTG | Aug 22, 2018 |
| Dompe Pharmaceuticals | For profit | NDA | Aug 22, 2018 |