EMCITATE (Tiratricol)

EMCITATE (tiratricol), from Egetis Therapeutics, is the first approved treatment for MCT8 deficiency (Allan-Herndon-Dudley syndrome), a rare genetic disorder in which thyroid hormone cannot enter certain cells. Patients suffer from too much thyroid hormone in the body (peripheral thyrotoxicosis) alongside severe neurodevelopmental problems. It is approved in the EU (from birth) and, since 28 September 2026, in the US for adults and children.

Tiratricol resembles the thyroid hormone T3 but does not need the MCT8 transporter to enter cells. In the main EU study of 46 children and adults, average T3 levels fell from 4.97 to 1.82 nmol/L after 12 months, with improvements in heart rate and blood pressure. It does not correct the underlying genetic defect or the neurological features.

• EMCITATE must not be used for other causes of hyperthyroidism or for primary hypothyroidism, and must not be used during pregnancy.
• Common side effects (up to 1 in 10) include excessive sweating, diarrhoea, irritability, anxiety and nightmares, mostly at the start of treatment or after dose increases.
• Thyroid hormone levels and clinical signs should be monitored by an endocrinologist to guide dosing.

What documents are required to import EMCITATE to India?

EMCITATE may be imported in the patient’s name only, by patients or government hospitals. The following documentation is required:

• A valid prescription from a registered paediatric endocrinologist
• Genetic report confirming SLC16A2 (MCT8) mutation and thyroid function tests
• Patient ID proof (issued by the Government of India)

How is the order confirmed?

The order is confirmed only after receipt and verification of a valid prescription.

Is EMCITATE available in India?

EMCITATE is not available in India. It can be legally accessed through the Named Patient Program (NPP), subject to applicable regulations.

Indian Pharma Network (IPN) can source EMCITATE from its authorized distribution network and facilitate supply to patients, doctors, and hospitals under applicable legal provisions.

For EMCITATE cost in India and availability, contact IPN at Phone: +91-9310090915 or email info@indianpharmanetwork.in.

Global Approval Status:

• European Union: Marketing authorisation — 12 February 2025.
• United States: FDA-approved — 28 September 2026.

What is EMCITATE used for?

EMCITATE (tiratricol) is a thyroid hormone (T3) analogue used for peripheral thyrotoxicosis in MCT8 deficiency (Allan-Herndon-Dudley syndrome).

Who manufactures EMCITATE?

EMCITATE is from Egetis Therapeutics.

How does EMCITATE work?

Tiratricol resembles the thyroid hormone T3 but does not need the MCT8 transporter to enter cells.

Does EMCITATE treat the neurological symptoms?

No. It treats the peripheral thyrotoxicosis; it does not restore thyroid hormone delivery to the brain.

Is EMCITATE approved by the US FDA?

Yes. The FDA approved EMCITATE on 28 September 2026.