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Molecule

Cenegermin

Recombinant Human Nerve Growth Factor
Available on requestBiologicOrphanCold chainOphthalmology
Presentations
2
Brands
1
Manufacturers
1
Available from stock
0

Cenegermin is a recombinant human nerve growth factor indicated for the treatment of neurotrophic keratitis. It is available as eye drops and kits for ophthalmic use. MedsAcross supplies Cenegermin for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.

Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review

Key facts

Pharmacological class
Recombinant Human Nerve Growth Factor
ATC classification
S01XA24 Cenegermin · Eye medicines, subgroup S01X, subgroup S01XA
US FDA first approval
22 August 2018
EU status
Authorised
Orphan designation
Yes
WHO essential medicine
Not recorded
India (CDSCO)
Not yet confirmed against CDSCO approval lists
Routes
Ophthalmic
Dosage forms
Eye drops, Kit
Biologic
Yes
Identifiers
UNII B6E7K36KT8Q30315101

Clinical information

From the regulator-approved product information. Each section names its source.

Uses

OXERVATE ® (cenegermin-bkbj) ophthalmic solution 0.002% is indicated for the treatment of neurotrophic keratitis. OXERVATE is a recombinant human nerve growth factor indicated for the treatment of neurotrophic keratitis.

Source: US FDA prescribing information

How it works

Nerve growth factor is an endogenous protein involved in the differentiation and maintenance of neurons, which acts through specific high-affinity (i.e., TrkA) and low-affinity (i.e. p75NTR) nerve growth factor receptors in the anterior segment of the eye to support corneal innervation and integrity.

Source: US FDA prescribing information

Dosing overview

One drop of OXERVATE in the affected eye(s), 6 times per day at 2-hour intervals, for eight weeks. General Dosing Information Contact lenses should be removed before applying OXERVATE and may be reinserted 15 minutes after administration. If a dose is missed, treatment should be continued as normal, at the next scheduled administration. If more than one topical ophthalmic product is being used, administer the eye drops at least 15 minutes apart to avoid diluting products. Administer OXERVATE 15 minutes prior to using any eye ointment, gel or other viscous eye drops.

Source: US FDA prescribing information

Warnings and precautions

Patients should remove contact lenses before applying OXERVATE and wait 15 minutes after instillation of the dose before reinsertion. Use with Contact Lens Contact lenses should be removed before applying OXERVATE because the presence of a contact lens (either therapeutic or corrective) could theoretically limit the distribution of cenegermin-bkbj onto the area of the corneal lesion. Lenses may be reinserted 15 minutes after administration. Eye Discomfort OXERVATE may cause mild to moderate eye discomfort such as eye pain during treatment. The patient should be advised to contact their doctor if a more serious eye reaction occurs.

Source: US FDA prescribing information

Side effects

The most common adverse reactions (incidence >5%) are eye pain, ocular hyperemia, eye inflammation and increased lacrimation.

Source: US FDA prescribing information

Storage

Storage Store the weekly cartons containing OXERVATE vials in the freezer at or below -4°F (-20°C). Patient Storage Within 5 hours of delivery, store the weekly carton(s) containing OXERVATE vials in the refrigerator between 36°F to 46°F (2°C to 8°C) for up to 14 days. A vial opened for daily use may be stored in the original weekly carton in the refrigerator between 36°F to 46°F (2°C to 8°C) or at room temperature up to 77°F (25°C), for up to 12 hours. Do not shake the vials.

Source: US FDA prescribing information

For healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.

All presentations

2 presentations of Cenegermin, sorted by availability.

MedicineManufacturerRegisterAvailability
Oxervate kit Cold chainDomp farmaceuticiUS FDAAvailable on request
Oxervate 20 mcg/mL eye dropsOphthalmic Cold chainDomp farmaceuticiUS FDAAvailable on request

Brands by market

1 brand names across 1 markets.

Brand names by country

United States

Manufacturers

Regulatory status

Approval facts from US FDA, EMA and CDSCO data, and registration status by country where we hold register data.

RegisterStatusSource
US FDAFirst approved 22 August 2018Drugs@FDA
EU (EMA)AuthorisedEMA medicines data
India (CDSCO)Not yet confirmed against CDSCO approval lists—
AustriaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
BelgiumRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
BulgariaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
CroatiaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
CyprusRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
CzechiaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
DenmarkRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
EstoniaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
FinlandRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
FranceRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
GermanyRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
GreeceRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
HungaryRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
IcelandRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
IrelandRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
ItalyRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
LatviaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
LiechtensteinRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
LithuaniaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
LuxembourgRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
MaltaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
NetherlandsRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
NorwayRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
PolandRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
PortugalRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
RomaniaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
SlovakiaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
SloveniaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
SpainRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
SwedenRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
United StatesRegisteredUS FDA (NDC directory, openFDA)Checked 12 November 2026

Questions and answers

Is Cenegermin available for export from India?

Yes, on request. MedsAcross lists 2 presentations of Cenegermin and sources them for licensed hospitals, importers and physicians against valid import documents.

What brand names does Cenegermin have?

The catalogue lists 1 brand names for Cenegermin, including Oxervate.

Is Cenegermin approved by the US FDA?

Yes. The US FDA first approved Cenegermin on 22 August 2018, according to Drugs@FDA.

Is Cenegermin authorised in the European Union?

Yes. Cenegermin has a central EU marketing authorisation (status: authorised), according to European Medicines Agency data.

Does Cenegermin need cold chain shipping?

At least one listed presentation of Cenegermin must be kept cold, so it is shipped in temperature-controlled packaging. Check the storage line on each presentation.

Which ATC class is Cenegermin in?

Cenegermin is classified under ATC code S01XA24 (Cenegermin).

References

  1. OXERVATE prescribing information (Domp farmaceutici). U.S. National Library of Medicine, DailyMed. Retrieved 5 October 2026
  2. Oxervate: European public assessment report (EPAR). European Medicines Agency. Retrieved 25 October 2024

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