ISOTREX (Isotretinoin)

ISOTREX capsules (isotretinoin), from Sun Pharma Japan, were approved in Japan on 19 June 2026 for neuroblastoma following high-dose chemotherapy. Neuroblastoma is a childhood cancer of immature nerve cells, and isotretinoin has long been used internationally as part of post-transplant maintenance to reduce the risk of relapse, but before this approval no product was authorised for this use in Japan.

Isotretinoin is a retinoid that pushes residual neuroblastoma cells to mature (differentiate) and stop dividing. The Japanese product uses a microparticle formulation designed to improve absorption. It is taken daily for 14 days followed by a 14-day break (one 28-day cycle), with the dose set by the child’s body weight or body-surface area.

• Isotretinoin is strongly teratogenic and can cause severe birth defects; pregnancy must be strictly avoided by patients and handled according to the approved risk-management requirements.
• Treatment should be managed by a paediatric oncologist, with monitoring of blood lipids, liver function, skin and mucosa.
• This Japanese approval is specific to neuroblastoma; isotretinoin products for acne in other countries are different products with different labelling.

Is ISOTREX available outside Japan?

ISOTREX is a Japanese product, and according to Japanese reports no other country had approved a product for this specific use as of early 2026. For a child in India whose oncologist recommends it, import may be explored on a named-patient basis; we check feasibility with the supplier first.

Which strengths are there?

ISOTREX comes as 8 mg and 16 mg capsules. The oncologist calculates the dose from the child’s weight or body-surface area; some doses are made by combining capsules.

What documents do we need?

• A prescription from a paediatric oncologist stating the dose and number of cycles
• Medical summary confirming neuroblastoma and completion of high-dose chemotherapy
• Patient ID proof (or the hospital’s details if the hospital is ordering)

The paediatric oncologist’s prescription is reviewed first, and the order is confirmed only after that.

How is ISOTREX stored?

The Japanese product information lists storage at room temperature.

ISOTREX is sold only in Japan, so the timeline depends on whether the Japanese distributor agrees to supply. We discuss availability and expected timing with the treating paediatric oncology team before any order is placed.

To ask about ISOTREX for a child’s treatment, call +91 96548 60915 or +91 93100 90915, WhatsApp +91 98104 69557, or email info@indianpharmanetwork.in.

Global Approval Status:

• Japan: Approved on 19 June 2026 for neuroblastoma after high-dose chemotherapy.
• United States: Isotretinoin is FDA-approved only for severe recalcitrant acne (other brands), not for neuroblastoma.

Sources:

• Sun Pharma Japan – ISOTREX capsules product information (Japanese)
• PMDA – ISOTREX package insert (Japanese, PDF)

Information last checked: November 2026.

What is ISOTREX (Isotretinoin) prescribed for?

ISOTREX is a retinoid (vitamin A derivative) indicated for neuroblastoma after high-dose chemotherapy (Japan).

Who markets ISOTREX?

ISOTREX comes from Sun Pharma Japan.

How does ISOTREX help?

Isotretinoin is a retinoid that pushes residual neuroblastoma cells to mature (differentiate) and stop dividing.

Is this the same as acne isotretinoin?

It is the same molecule, but ISOTREX capsules are approved in Japan specifically for neuroblastoma maintenance, with a cyclical dosing schedule.

Why is ISOTREX taken in cycles?

The Japanese label uses 28-day cycles: capsules every day for 14 days, then a 14-day break, repeated as the oncologist directs.

What is the FDA status of ISOTREX?

Isotretinoin is FDA-approved for severe acne under other brands, but not for neuroblastoma; ISOTREX capsules are a Japanese product.