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Molecule

Tildrakizumab

Interleukin-23 Antagonist
Available on requestBiologicCold chainImmunology and transplantRheumatology
Presentations
2
Brands
1
Manufacturers
1
Available from stock
0

Tildrakizumab is an interleukin-23 antagonist indicated for the treatment of moderate-to-severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy, among other approved uses. It is available as injection for subcutaneous use. MedsAcross supplies Tildrakizumab 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
Interleukin-23 Antagonist, Interleukin-23 Antagonists
ATC classification
L04AC17 Tildrakizumab · Immunosuppressive drug, subgroup L04AC
US FDA first approval
20 March 2018
EU status
Authorised
Orphan designation
No
WHO essential medicine
Not recorded
India (CDSCO)
Not yet confirmed against CDSCO approval lists
Routes
Subcutaneous
Dosage forms
Injection
Biologic
Yes
Identifiers
UNII DEW6X41BEKRxCUI 2053436CAS 1326244-10-3DrugBank DB14004Q15708331

Clinical information

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

Uses

ILUMYA is an interleukin-23 antagonist indicated for the treatment of moderate-to-severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy. active psoriatic arthritis in adult patients.

Source: US FDA prescribing information

How it works

Tildrakizumab is a humanized IgG1/k monoclonal antibody that selectively binds to the p19 subunit of IL-23 and inhibits its interaction with the IL-23 receptor. IL-23 is a naturally occurring cytokine that is involved in inflammatory and immune responses. Tildrakizumab inhibits the release of proinflammatory cytokines and chemokines.

Source: US FDA prescribing information

Dosing overview

See the full prescribing information for recommended evaluations and immunizations prior to treatment. Administer ILUMYA by subcutaneous injection. Recommended dosage: Moderate-to-Severe Plaque Psoriasis 100 mg at Weeks 0, 4, and every 12 weeks thereafter. Active Psoriatic Arthritis For adult patients with active psoriatic arthritis and coexistent moderate-to-severe plaque psoriasis, the recommended dosage is the same as in adults with moderate-to-severe plaque psoriasis. For other adult patients with active psoriatic arthritis: 100 mg every 12 weeks.

Source: US FDA prescribing information

Contraindications

ILUMYA is contraindicated in patients with a history of serious hypersensitivity reaction to tildrakizumab or to any of the excipients. Serious hypersensitivity reaction to tildrakizumab or to any of the excipients.

Source: US FDA prescribing information

Warnings and precautions

Hypersensitivity: If a serious allergic reaction occurs, discontinue ILUMYA immediately and initiate appropriate therapy. Infections: ILUMYA may increase the risk of infection. Instruct patients to seek medical advice if signs or symptoms of clinically important chronic or acute infection occur. If a serious infection develops, consider discontinuing ILUMYA until the infection resolves. Pretreatment Evaluation for Tuberculosis (TB): Evaluate for TB prior to initiating treatment. Immunizations: Avoid use of live vaccines.

Source: US FDA prescribing information

Side effects

The following serious adverse reactions are discussed elsewhere in the labeling: Hypersensitivity Reactions Infections Most common adverse reactions associated with ILUMYA treatment are Plaque Psoriasis (≥1%): upper respiratory infections, injection site reactions, and diarrhea. Psoriatic Arthritis (≥3%): upper respiratory tract infections and COVID-19.

Source: US FDA prescribing information

Storage

Store refrigerated at 2°C to 8°C (36°F to 46°F) in the original carton to protect from light until the time of use. Do not freeze. ILUMYA can be kept at room temperature at 25°C (77°F) for up to 30 days in the original carton to protect from light. Once stored at room temperature, do not place back in the refrigerator. Do not store ILUMYA above 25°C (77°F). Do not shake.

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 Tildrakizumab, sorted by availability.

MedicineManufacturerRegisterAvailability
Ilumya 100 mg/1 mL injectionSubcutaneous Cold chainSun Pharmaceutical IndustriesIndiaUS FDAAvailable on request
Ilumya 100 mg/mL injectionSubcutaneous Cold chainSun Pharmaceutical IndustriesIndiaUS FDAAvailable on request

Brands by market

1 brand names across 1 markets.

Brand names by country

United States

Manufacturers

Indian manufacturers are highlighted.

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 20 March 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 Tildrakizumab available for export from India?

Yes, on request. MedsAcross lists 2 presentations of Tildrakizumab and sources them for licensed hospitals, importers and physicians against valid import documents. Indian manufacturers include Sun Pharmaceutical Industries.

What brand names does Tildrakizumab have?

The catalogue lists 1 brand names for Tildrakizumab, including Ilumya.

Is Tildrakizumab approved by the US FDA?

Yes. The US FDA first approved Tildrakizumab on 20 March 2018, according to Drugs@FDA.

Is Tildrakizumab authorised in the European Union?

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

Does Tildrakizumab need cold chain shipping?

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

Which ATC class is Tildrakizumab in?

Tildrakizumab is classified under ATC code L04AC17 (Tildrakizumab).

References

  1. ILUMYA prescribing information (Sun Pharmaceutical Industries). U.S. National Library of Medicine, DailyMed. Retrieved 2 November 2026
  2. Ilumetri: European public assessment report (EPAR). European Medicines Agency. Retrieved 7 May 2026

Request Tildrakizumab for export supply

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