HAIZEXIN (Risovalisib)

HAIZEXIN (risovalisib), developed by Haihe Biopharma, was approved in Japan on 23 March 2026 for PIK3CA-mutated ovarian clear cell carcinoma that has progressed after chemotherapy. Ovarian clear cell carcinoma is relatively common in Japan and often responds poorly to standard chemotherapy. Taiho Pharmaceutical markets the product in Japan, where it launched in July 2026.

Risovalisib selectively blocks PI3K-alpha, the enzyme switched on by PIK3CA mutations that drives tumour growth. Patients are selected with the AmoyDx PIK3CA Mutation Detection Kit, approved alongside it as a companion diagnostic. The approval was supported by the Phase 2 CYH33-G201 study.

• A PIK3CA mutation must be confirmed with an approved test before treatment.
• HAIZEXIN is approved only in Japan; the Japanese package insert should be reviewed for full dosing, side effects and monitoring.
• Treatment should be supervised by a gynaecologic oncologist.

Can HAIZEXIN be imported to India?

HAIZEXIN is approved only in Japan, where Taiho Pharmaceutical launched it on 28 July 2026. For a patient in India whose oncologist recommends it, import may be explored on a named-patient basis; we check feasibility with the supplier before confirming.

How many tablets are needed?

According to Taiho, the usual adult dose is 40 mg once daily taken on an empty stomach, which is four 10 mg tablets a day (about 120 tablets for 30 days). The doctor may reduce the dose depending on the patient’s condition.

What documents do we need?

• A prescription from a gynaecologic or medical oncologist stating the dose
• Histopathology confirming ovarian clear cell carcinoma and a PIK3CA mutation test report
• A government photo ID for the patient (or hospital details if the hospital is ordering)

After the oncologist’s prescription and the PIK3CA report are reviewed, we confirm whether the order can go ahead.

Is a genetic test required?

Yes. HAIZEXIN is only for tumours with a PIK3CA mutation, so the mutation must be confirmed before treatment.

Supply of a Japan-only medicine needs agreement from the Japanese distributor, so lead times can be longer than for US or EU products. IPN confirms availability and timelines before taking an order.

Oncologists and families can reach us about HAIZEXIN on +91 96548 60915 or +91 93100 90915 (WhatsApp +91 98104 69557), or by email at info@indianpharmanetwork.in.

Global Approval Status:

• Japan: Approved on 23 March 2026 (orphan drug designation).
• United States / European Union: Not approved as of November 2026.

Sources:

• Taiho Pharmaceutical: launch of HAIZEXIN tablets 10 mg in Japan (15 July 2026)

Information last checked: November 2026.

What is HAIZEXIN (Risovalisib) prescribed for?

HAIZEXIN is an oral PI3K-alpha inhibitor indicated for PIK3CA-mutated ovarian clear cell carcinoma.

Who markets HAIZEXIN?

HAIZEXIN comes from Haihe Biopharma (marketed in Japan by Taiho Pharmaceutical).

How does HAIZEXIN help?

Risovalisib selectively blocks PI3K-alpha, the enzyme switched on by PIK3CA mutations that drives tumour growth.

Is HAIZEXIN chemotherapy?

No. It is a targeted oral tablet that blocks the PI3K-alpha enzyme in tumours with PIK3CA mutations.

Should HAIZEXIN be taken with food?

No. Taiho states that it is taken once daily in a fasting condition, i.e. on an empty stomach.

What is the FDA status of HAIZEXIN?

It is not FDA-approved. As of November 2026 it is approved in Japan only.