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Molecule

Eplontersen

Antisense Oligonucleotide
Available on requestOrphanCold chainNeurology
Presentations
1
Brands
1
Manufacturers
1
Available from stock
0

Eplontersen is an antisense oligonucleotide indicated for the treatment of the polyneuropathy of hereditary transthyretin-mediated amyloidosis in adults. It is available as injection for subcutaneous use. MedsAcross supplies Eplontersen 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
Antisense Oligonucleotide, Oligonucleotides, Transthyretin-directed RNA Interaction, Decreased RNA Integrity, Increased Protein Breakdown
ATC classification
N07XX21 Eplontersen · Other nervous system medicines, subgroup N07X, subgroup N07XX
US FDA first approval
21 December 2023
EU status
Authorised
Orphan designation
Yes
WHO essential medicine
Not recorded
India (CDSCO)
Not yet confirmed against CDSCO approval lists
Routes
Subcutaneous
Dosage forms
Injection
Identifiers
UNII 0GRZ0F5XJ6CAS 1637600-16-8DrugBank DB16199Q123663227

Clinical information

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

Uses

WAINUA is indicated for the treatment of the polyneuropathy of hereditary transthyretin-mediated amyloidosis in adults. WAINUA is a transthyretin-directed antisense oligonucleotide indicated for the treatment of the polyneuropathy of hereditary transthyretin-mediated amyloidosis in adults.

Source: US FDA prescribing information

How it works

Eplontersen is an antisense oligonucleotide-GalNAc conjugate that causes degradation of mutant and wild-type TTR mRNA through binding to the TTR mRNA, which results in a reduction of serum TTR protein and TTR protein deposits in tissues.

Source: US FDA prescribing information

Dosing overview

• The recommended dosage of WAINUA is 45 mg administered by subcutaneous injection once monthly. • Administer WAINUA into the abdomen or upper thigh region, the back of the upper arm can be used if a healthcare provider or caregiver administers the injection. • The prefilled syringe must be administered by a healthcare provider.

Source: US FDA prescribing information

Warnings and precautions

Reduced Serum Vitamin A Levels and Recommended Supplementation: Supplement with the recommended daily allowance of vitamin A. Refer to an ophthalmologist if ocular symptoms suggestive of vitamin A deficiency occur.

Source: US FDA prescribing information

Side effects

The following clinically significant adverse reactions are discussed in greater detail in other sections of the labeling: • Reduced Serum Vitamin A Levels and Recommended Supplementation. Most common adverse reactions (that occurred in at least 9% of patients treated with WAINUA) were vitamin A decreased and vomiting.

Source: US FDA prescribing information

Storage

Store refrigerated at 2°C to 8°C (36°F to 46°F) in the original carton protected from light. If needed, WAINUA can be kept at room temperature (up to 30°C [86°F]) in the original carton for up to 6 weeks. If not used within the 6 weeks stored at room temperature, discard WAINUA. Do not freeze.

Source: US FDA prescribing information

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

All presentations

1 presentations of Eplontersen, sorted by availability.

MedicineManufacturerRegisterAvailability
Wainua 45 mg/0.8 mL injectionSubcutaneous Cold chainAstraZeneca PharmaceuticalsUS 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 21 December 2023Drugs@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 Eplontersen available for export from India?

Yes, on request. MedsAcross lists 1 presentations of Eplontersen and sources them for licensed hospitals, importers and physicians against valid import documents.

What brand names does Eplontersen have?

The catalogue lists 1 brand names for Eplontersen, including Wainua.

Is Eplontersen approved by the US FDA?

Yes. The US FDA first approved Eplontersen on 21 December 2023, according to Drugs@FDA.

Is Eplontersen authorised in the European Union?

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

Does Eplontersen need cold chain shipping?

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

Which ATC class is Eplontersen in?

Eplontersen is classified under ATC code N07XX21 (Eplontersen).

References

  1. WAINUA prescribing information (AstraZeneca Pharmaceuticals). U.S. National Library of Medicine, DailyMed. Retrieved 15 April 2026
  2. Wainzua: European public assessment report (EPAR). European Medicines Agency. Retrieved 27 January 2026

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