Cenegermin-Bkbj

Sold as Oxervate. Every FDA application for this active ingredient.

As of Nov 15, 2026, FDA lists 1 application for Cenegermin-Bkbj (sold as Oxervate), first approved Aug 22, 2018, with 0 new uses approved and 0 published complete response letters.

First approved: Aug 22, 2018
Applications: 1
New uses approved: 0
Complete response letters: 0
Medicare spending, 2025: $1.09B
First approved in the EU: Jul 6, 2017

Medicare Spending

CMS Part D and Part B, 2025, before manufacturer rebates; matched by generic name

Product	Part	Spending, 2025	Change	Beneficiaries
Oxervate	Part D	$1.09B	+53%	6,903

Orphan Designations (FDA)

2 designations, 1 approved for the designated use; see all orphan designations

treatment of neonatal hypoxic ischemic encephalopathyDompé farmaceutici S.p.A. · designated Oct 28, 2024
Treatment of neurotrophic keratitisDompe S.p.A. · designated Jun 23, 2014 · approved Aug 22, 2018

Approvals in the EU (EMA)

First approved in the EU 14 months before the US. Centrally authorised medicines, matched by ingredient; see all EU approvals

Oxervate, new substanceDompe' Farmaceutici S.p.A. · Jul 6, 2017

Clinical Trials

1 open or ongoing study names this ingredient as an intervention, including as a comparator; newest first. See all

Study	Phase	Status	Posted
DOMPE -MT Neurotrophic KeratitisDry Eye, Neurotrophic Keratitis · Toyos Clinic	Phase 4	Active, not recruiting	Apr 27, 2025

Applications

NDAs, BLAs and generic ANDAs for this ingredient, oldest first; each opens its full history

Approved	Application	Sponsor	Supplements	Marketing
Aug 22, 2018	OxervateBLA 761094 · New molecular entity	Dompe Farmaceutici	3	Marketed

Applications, approvals and products come from FDA's Drugs@FDA data files, refreshed weekly, grouped by active ingredient as FDA spells it. Complete response letters are FDA's published letters. Medicare spending is CMS's Part D and Part B dashboard, matched to this ingredient by generic name; shortages are FDA's shortage list, matched by application number; clinical trials are ClinicalTrials.gov studies naming the ingredient as an intervention, refreshed daily; safety programs are FDA's REMS list, matched by application number or, for shared programs, by ingredient. Drugs@FDA