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MedsAcross

Molecule

Zilucoplan

Complement Inhibitor
Available on requestOrphanImmunology and transplant
Presentations
3
Brands
1
Manufacturers
1
Available from stock
0

Zilucoplan is a complement Inhibitor. MedsAcross lists 3 presentations of it from 1 manufacturers, with brand names, strengths, packs and regulatory status for each. It is available for export supply from India to licensed hospitals, importers and physicians, with the documents the destination country requires.

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

Key facts

Pharmacological class
Complement Inhibitor, Complement Inhibitors
ATC classification
L04AJ06 Zilucoplan · Immunosuppressive drug, subgroup L04AJ
US FDA first approval
17 October 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 YG391PK0CCCAS 1841136-73-9DrugBank DB15636Q107340140

All presentations

3 presentations of Zilucoplan, sorted by availability.

MedicineManufacturerRegisterAvailability
Zilbrysq 16.64 mg/0.416 mL injectionSubcutaneousUCBUS FDAAvailable on request
Zilbrysq 22.96 mg/0.574 mL injectionSubcutaneousUCBUS FDAAvailable on request
Zilbrysq 32.4 mg/0.81 mL injectionSubcutaneousUCBUS 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 17 October 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

Conditions

Conditions linked to Zilucoplan in public data. This is not a list of approved uses, see the clinical information.

Questions and answers

Is Zilucoplan available for export from India?

Yes, on request. MedsAcross lists 3 presentations of Zilucoplan and sources them for licensed hospitals, importers and physicians against valid import documents.

What brand names does Zilucoplan have?

The catalogue lists 1 brand names for Zilucoplan, including Zilbrysq.

Is Zilucoplan approved by the US FDA?

Yes. The US FDA first approved Zilucoplan on 17 October 2023, according to Drugs@FDA.

Is Zilucoplan authorised in the European Union?

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

Does Zilucoplan need cold chain shipping?

No listed presentation of Zilucoplan is recorded as needing a cold chain. Storage conditions are shown on each presentation page.

Which ATC class is Zilucoplan in?

Zilucoplan is classified under ATC code L04AJ06 (Zilucoplan).

References

  1. Zilbrysq: European public assessment report (EPAR). European Medicines Agency. Retrieved 9 September 2026

Request Zilucoplan for export supply

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