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Molecule

Icotrokinra

Presentations
1
Brands
1
Manufacturers
1
Available from stock
0

Icotrokinra is a prescription medicine indicated for the treatment of moderate-to-severe plaque psoriasis in adults and pediatric patients 12 years of age and older, among other approved uses. It is available as tablets for oral use. MedsAcross supplies Icotrokinra 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

ATC classification
L04AC28 Icotrokinra · Immunosuppressive drug, subgroup L04AC
US FDA first approval
17 March 2026
EU status
Authorised
Orphan designation
No
WHO essential medicine
Not recorded
India (CDSCO)
Not yet confirmed against CDSCO approval lists
Routes
Oral
Dosage forms
Tablet
Identifiers
UNII MUW8FP7HNZCAS 2763602-16-8Q131418207

Clinical information

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

Uses

ICOTYDE is indicated for the treatment of moderate-to-severe plaque psoriasis in adults and pediatric patients 12 years of age and older who weigh at least 40 kg who are candidates for systemic therapy or phototherapy. ICOTYDE is an interleukin-23 (IL-23) receptor antagonist indicated for the treatment of moderate-to-severe plaque psoriasis in adults and pediatric patients 12 years of age and older who weigh at least 40 kg who are candidates for systemic therapy or phototherapy.

Source: US FDA prescribing information

How it works

Icotrokinra is a peptide that selectively binds to the IL-23 receptor (IL-23R) with a dissociation constant of 7 pM and antagonizes the binding of IL-23. IL-23 is a naturally occurring cytokine that is involved in inflammatory and immune responses. Icotrokinra inhibits the IL-23/IL-23R-dependent release of proinflammatory cytokines.

Source: US FDA prescribing information

Dosing overview

See the full prescribing information for recommended evaluation and immunizations prior to treatment. Recommended dosage is 200 mg orally once daily. Administer ICOTYDE on an empty stomach with water upon waking. Wait at least 30 minutes after taking ICOTYDE before eating food. For patients who have difficulty swallowing tablets, ICOTYDE can be dispersed in water.

Source: US FDA prescribing information

Warnings and precautions

Infections: Avoid treatment with ICOTYDE in patients with any clinically important active infection until the infection resolves or is adequately treated. If such an infection develops, discontinue ICOTYDE until the infection resolves. Tuberculosis (TB): Consider evaluating for TB prior to initiating treatment with ICOTYDE based on clinical judgment. Monitor patients for signs and symptoms of active TB during and after treatment with ICOTYDE. Immunizations: Avoid use of live vaccines during treatment with ICOTYDE.

Source: US FDA prescribing information

Storage

Store at 20 °C to 25 °C (68 °F to 77 °F), excursions permitted between 15 °C to 30 °C (59 °F to 86 °F). Store in original package to protect from moisture.

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 Icotrokinra, sorted by availability.

MedicineManufacturerRegisterAvailability
Icotyde 200 mg tabletOralJanssen BiotechUS 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 March 2026Drugs@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 Icotrokinra available for export from India?

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

What brand names does Icotrokinra have?

The catalogue lists 1 brand names for Icotrokinra, including Icotyde.

Is Icotrokinra approved by the US FDA?

Yes. The US FDA first approved Icotrokinra on 17 March 2026, according to Drugs@FDA.

Is Icotrokinra authorised in the European Union?

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

Does Icotrokinra need cold chain shipping?

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

Which ATC class is Icotrokinra in?

Icotrokinra is classified under ATC code L04AC28 (Icotrokinra).

References

  1. ICOTYDE prescribing information (Janssen Biotech). U.S. National Library of Medicine, DailyMed. Retrieved 17 March 2026
  2. Icotyde: European public assessment report (EPAR). European Medicines Agency. Retrieved 22 September 2026

Request Icotrokinra for export supply

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