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Komzifti

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Komzifti

Supplied with complete CDSCO-approved import and customs documentation, including Form 12A & 12B, CDEC, GST Bill of Entry, Commercial Invoice, and Packing List.

Medicine Name: Komzifti
Generic Name (API): Ziftomenib
Dosage Form & Strength: 200 mg
Route: Oral
Drug Class: Menin inhibitor

Manufacturer / Innovator:

Germany

Regulatory Approval:

  • FDA-approved (November 2025) for adult patients with relapsed or refractory acute myeloid leukemia (AML) with a susceptible NPM1 mutation
  • as detected by an FDA-approved test
  • who have no satisfactory alternative treatment options.
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    Temperature-controlled logistics ensuring safe, reliable, and timely medicine delivery.

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Understanding Komzifti (Ziftomenib) and Its Medical Uses

Komzifti (ziftomenib) is an oral, once-daily menin inhibitor and the first FDA-approved targeted therapy specifically for NPM1-mutated acute myeloid leukemia (AML). It received FDA approval in November 2025.

Approved Indication

Komzifti is FDA-approved for adult patients with relapsed or refractory AML with a susceptible NPM1 mutation, as detected by an FDA-approved test, who have no satisfactory alternative treatment options.

How It Works

Ziftomenib blocks the interaction between menin and the KMT2A (MLL) protein complex, disrupting the abnormal gene expression program that NPM1-mutated leukemia cells depend on for survival and proliferation.

Dosing

The recommended dose is 600 mg orally once daily, taken on an empty stomach, until disease progression or unacceptable toxicity, as determined by the treating hematologist-oncologist.

Warnings and Precautions for Komzifti

Boxed Warning — Komzifti: Komzifti can cause fatal or life-threatening differentiation syndrome. Signs and symptoms may include fever, joint pain, hypotension, hypoxia, difficulty breathing, rapid weight gain or peripheral edema, pleural or pericardial effusions, pulmonary infiltrates, acute kidney injury, and rashes. If suspected, interrupt Komzifti and initiate corticosteroids with hemodynamic and laboratory monitoring. Komzifti can also cause QTc interval prolongation; concomitant use with other QT-prolonging drugs may increase the risk of serious arrhythmias, including Torsades de pointes and sudden death.

Differentiation Syndrome

Monitor closely, particularly during the first weeks of treatment. Treat promptly with corticosteroids at the first suspicion of symptoms.

QTc Interval Prolongation

Obtain ECGs and correct electrolyte abnormalities (hypokalemia, hypomagnesemia) before starting treatment. Interrupt Komzifti if QTc exceeds 500 ms.

Drug Interactions

Avoid concomitant use with strong CYP3A inhibitors/inducers and other QT-prolonging medications without physician guidance.

  • Monitor for fever, breathing difficulty, and rapid weight gain, which may signal differentiation syndrome.
  • Regular ECG and electrolyte monitoring is required throughout treatment.
  • Report any new symptoms to the treating physician immediately.

How to Access Komzifti in India: A 6-Step Process

Step 1 – Search & request your medicine: The patient or treating doctor submits a request with basic details to initiate the access process.

Step 2 – Verification & eligibility review: The team verifies availability and reviews eligibility against regulatory and clinical requirements to ensure a compliant pathway.

Step 3 – Receive quote & delivery timeline: A transparent quotation is shared, covering medicine cost, logistics, and a clear delivery timeline.

Step 4 – Regulatory approval process: Assistance is provided to secure the approvals and documentation required for legal cross-border access.

Step 5 – Temperature-controlled import & handling: The medicine is sourced and transported under strict GDP-compliant conditions to maintain product integrity.

Step 6 – Secure delivery: The medicine is delivered to the patient or treating hospital, with updates provided at each stage.

Note: From request to delivery, every step is designed to ensure your treatment reaches you safely, compliantly, and without unnecessary delays.

Documentation and Availability of Komzifti

Komzifti (ziftomenib) received FDA approval in November 2025, making it the first approved menin inhibitor specifically for NPM1-mutated AML. It is developed and commercialized by Kura Oncology in partnership with Kyowa Kirin.

Documentation Required

Import of Komzifti through a Named Patient Program requires a valid prescription from the treating hematologist-oncologist, confirmation of NPM1 mutation status via an FDA-approved test, and supporting clinical documentation as required by Indian regulatory authorities.

Sourcing

NPP sources Komzifti directly from Kura Oncology's authorized supply chain to ensure product authenticity and regulatory compliance.

Sourcing and Delivery of Komzifti

Komzifti is sourced through verified, GDP-compliant channels from its authorized supply chain to ensure authenticity and quality.

Storage Requirements

Komzifti capsules should be stored at 20°C to 25°C (68°F to 77°F), with excursions permitted between 15°C and 30°C (59°F to 86°F).

Delivery Process

Once sourced, Komzifti is packed and transported under appropriate temperature-controlled conditions to preserve product integrity throughout the import process, with tracking and updates provided at each stage of delivery to the patient or treating hospital in India.

Availability of Komzifti Across Major Cities in India

Patients across India can access Komzifti through NPP's regulated import pathway, with hematology-oncology specialists in major cities supporting the treatment process.

Mumbai

Leading hematology-oncology centers in Mumbai support NPM1 mutation testing and treatment coordination for Komzifti access.

Delhi

Delhi's major cancer hospitals assist patients with molecular testing and prescription support for Komzifti.

Bangalore

Bangalore's oncology network offers access to NPM1 testing and treatment planning for eligible AML patients.

Chennai

Chennai-based specialists coordinate Komzifti access alongside comprehensive AML care.

Hyderabad

Hyderabad's cancer care institutions support patients pursuing Komzifti therapy following confirmed NPM1 mutation status.

Kolkata

Kolkata's oncology centers help coordinate documentation and treatment access for Komzifti.

Pune

Pune-based hematologists assist with NPM1 mutation testing and Komzifti treatment planning.

Ahmedabad

Ahmedabad's specialty hospitals support the import and treatment process for Komzifti.

Kochi

Kochi's oncology units assist patients with the documentation needed for Komzifti access.

Chandigarh

Chandigarh's cancer care centers support Komzifti treatment coordination for patients from North India.

Jaipur

Jaipur's oncology specialists help patients navigate the Komzifti access process.

Lucknow

Lucknow-based cancer centers assist patients pursuing Komzifti therapy.

Bhubaneswar

Bhubaneswar's oncology institutions support access to Komzifti for eligible patients.

Guwahati

Guwahati's specialists help coordinate Komzifti access for patients across the Northeast.

Patients in other cities across India can also access Komzifti through NPP's nationwide coordination network.

Written By:

Written By: Nitin Goswami, Senior Medical Content Writer
Last Updated: 09 September 2026
Sources: FDA • CDSCO

Medically Reviewed By:

Medically Reviewed By: Shilpi Banerjee, Registered Pharmacist (M.Pharm)
Last Updated: 09 September 2026

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