Thai FDA approves IMCRANIB 400 to widen cancer drug access

Thailand’s Food and Drug Administration has approved IMCRANIB 400, a Thai-made targeted cancer drug designed to expand patient access to quality treatment, reduce dependence on imported medicines and make therapy more convenient for patients who previously had to take several tablets per dose.

Supattra Boonserm, secretary-general of the Food and Drug Administration (FDA), on Wednesday presented the drug registration certificate for IMCRANIB 400 to Dr Wachara Kanchanakawinkul, director of the Royal Initiative Pharmaceutical Manufacturing Plant under Chulabhorn Royal Academy.

The medicine is a new 400mg strength of a targeted cancer therapy researched and produced by Thai experts.

A step towards medicine security

Supattra said the approval marked another important milestone in Thailand’s development of domestically produced cancer medicines.

IMCRANIB 400 builds on the success of IMCRANIB 100, which was approved by the FDA in 2025 as the first targeted therapy formulation manufactured in Thailand.

The development follows the vision of Her Royal Highness Princess Chulabhorn Krom Phra Srisavangavadhana, who has promoted Thailand’s medicine security, reduced reliance on imported drugs and improved access to quality treatment at reasonable prices for Thai patients.

New strength designed for patient convenience

IMCRANIB 400 contains imatinib, a targeted therapy that works by inhibiting enzymes involved in the growth of cancer cells.

The new 400mg strength was developed to make treatment more convenient for patients. Instead of taking several tablets at a time, some patients may be able to take a single tablet per dose, which could help improve treatment adherence and reduce the chance of missed doses.

IMCRANIB 100, approved in May 2025 and piloted at Chulabhorn Hospital, was reported to have cut treatment costs by more than 40-fold compared with imported medicines.

Produced in Thailand under international standards

The FDA said IMCRANIB 400 is produced using modern technology under international GMDP PIC/S standards at the Royal Initiative Pharmaceutical Manufacturing Plant in Chonburi province.

This is intended to ensure that the medicine meets standards for quality, safety and efficacy comparable to imported drugs, while allowing more patients to access treatment.

How the drug works

IMCRANIB 400 works by inhibiting tyrosine kinase, an enzyme involved in signalling cancer cell division.

By blocking the activity of abnormal cells, the medicine can help slow the growth or spread of cancer cells and support long-term disease control in certain patients.

A key advantage of targeted therapies is that they act more specifically on cancer cells than conventional chemotherapy, which may reduce the impact on normal cells.

Conditions treated and possible side effects

IMCRANIB 400 is used in the treatment of several diseases linked to genetic and enzyme abnormalities in cells, including chronic myeloid leukaemia (CML), Philadelphia chromosome-positive acute lymphoblastic leukaemia (Ph+ ALL), gastrointestinal stromal tumour (GIST), certain bone marrow disorders such as MDS/MPD and hypereosinophilic syndrome, and some rare skin cancers such as dermatofibrosarcoma protuberans (DFSP).

Although targeted therapy may cause fewer side effects than conventional chemotherapy, adverse reactions can still occur. These may include nausea, vomiting, fatigue, muscle pain, rash, itching, diarrhoea, loss of appetite, swelling around the eyes or swelling in other parts of the body.

Patients should seek medical attention immediately if they experience difficulty breathing, abnormal bleeding, frequent infections, high fever, severe swelling or signs of hepatitis. Those with underlying conditions such as liver disease or heart disease, as well as pregnant women, should be closely assessed by a doctor before using the medicine.