Price: quote on request. Your total cost is quoted in writing per case.
Written estimate for your case
Get my quote

Is Komzifti available in Bahrain? How families get Komzifti (ziftomenib)

A plain answer for families in Bahrain, checked against FDA, manufacturer and regulator sources.

Reviewed by the Reserve Meds clinical operations team on 17 October 2026.

Is Komzifti available in Bahrain?

Komzifti (ziftomenib) is an FDA-approved oral menin inhibitor for relapsed or refractory NPM1-mutated acute myeloid leukemia (AML). Komzifti is not on NHRA's Registered Medicine Price List (version dated 7 September 2026, 5,560 entries) or on its Temporary Importation Medicines List (dated 19 January 2025). We checked both on 17 October 2026. The legal route is a named-patient request: the treating hospital, on your specialist's request, asks the National Health Regulatory Authority (NHRA) for permission to import Komzifti for one patient, using the US FDA approval as the reference. Once approved, Reserve Meds arranges supply through a US-licensed pharmaceutical wholesale partner to the hospital pharmacy. We do not prescribe.

  • Registration in Bahrain: not on NHRA's registered list (7 September 2026) or temporary importation list (19 January 2025), checked 17 October 2026.
  • Legal route: Named-patient import request to NHRA, filed by the treating hospital.
  • Who applies: a government or private hospital in Bahrain, on the written request of your treating specialist.
  • Timeline: We give you a written timeline estimate once we see the hospital file. The regulator and the manufacturer set their own timelines.
  • Price: Quote on request. Every case gets a written custom quote before you commit.

What Komzifti is

Komzifti (ziftomenib) is made by Kura Oncology. The US FDA approved it on 13 November 2025 for adults with relapsed or refractory acute myeloid leukemia (AML) with a susceptible NPM1 mutation who have no satisfactory alternative treatment options. It is given as 600 mg by mouth once a day.

In the KOMET-001 trial, 23% of patients reached complete remission or complete remission with partial blood count recovery. Warnings include differentiation syndrome, heart rhythm (QTc) changes, and harm to an unborn baby.

We found no approval outside the United States in public sources as of 13 October 2026.

Registration status in Bahrain

Komzifti is not on NHRA's Registered Medicine Price List (version dated 7 September 2026, 5,560 entries) or on its Temporary Importation Medicines List (dated 19 January 2025). We checked both on 17 October 2026. The same registered list does include other specialty therapies, such as Zolgensma, Casgevy and Elevidys, so it does cover this kind of medicine.

NHRA updates its lists. Ask the hospital pharmacy to confirm the current status with NHRA's pharmaceutical products regulation section before anything is filed.

The legal route in Bahrain

Under NHRA Circular No. (41) of 2020, government and private hospitals must get NHRA's permission before they issue a purchase order for a medicine that is not registered in Bahrain.

The circular asks that the medicine is important and has no registered alternative in Bahrain, is registered with the Gulf Health Council or in a GCC country, is registered with a reference authority such as the US FDA, and is marketed in its country of origin.

Some medicines for rare diseases, emergencies and tumors with no registered alternative can be excused from the registration and marketing conditions, through NHRA's list of emergency medicines or with Board approval.

The request goes to NHRA by email with the application form, a Certificate of Pharmaceutical Product (CPP) or registration certificate from a reference authority, and a Good Manufacturing Practice (GMP) certificate. NHRA's 2022 application form is signed by the importing hospital, the agent or the marketing authorization holder, who takes full responsibility for the product's quality and safety.

Who does what

  • Your treating specialist decides whether Komzifti is right for the patient and writes the letter and prescription.
  • The hospital checks the route, files any request and is responsible for giving the medicine safely.
  • The National Health Regulatory Authority (NHRA) decides whether to approve an import of a medicine that is not registered.
  • Kura Oncology makes Komzifti and decides where it can be supplied.
  • Reserve Meds coordinates the paperwork, the US supply through our wholesale partner, shipping and updates to your family. We do not give medical advice.

Documents the hospital will usually need

  • A letter from the treating specialist: diagnosis, past treatments, and why Komzifti is needed
  • A prescription with the dose and how long treatment should last
  • Supporting reports, such as pathology, genetic or laboratory results
  • The hospital's request form and its signed declaration of responsibility
  • Written consent from the patient or a legal guardian
  • Proof of the US FDA approval and the US prescribing information (we can supply these)

Timeline, step by step

  1. Doctor's letter. Your specialist writes the clinical letter and prescription.
  2. Hospital request. The hospital pharmacy files the request with NHRA.
  3. Regulator decision. NHRA reviews the request and issues an approval or asks for more information.
  4. US sourcing. Our US-licensed wholesale partner supplies the medicine, and it is shipped with the right temperature controls.
  5. Hospital receipt. The medicine is received at the hospital pharmacy, which gives it to the patient.

We give you a written timeline estimate once we see the hospital file. The regulator and the manufacturer set their own timelines.

What Komzifti costs

Quote on request. Your total cost depends on the dose, shipping, import steps and coordination. Your coordination fee is quoted in writing for your case before you commit. No hidden charges.

How Reserve Meds helps

Reserve Meds is a digital health company. Medicines are supplied through a US-licensed pharmaceutical wholesale partner. We help your doctor and hospital prepare the file, arrange US supply and shipping once approval is in place, and keep your family updated. We coordinate access to FDA-approved medicines only. We do not prescribe, and we do not decide what the regulator approves.

Ask us about Komzifti in Bahrain

Tell us the medicine, the country, and how to reach you. We reply within one business day. On WhatsApp we usually reply the same day.

Message us on WhatsApp Already have a case? Sign in

Your coordination fee is quoted in writing for your case before you commit. No hidden charges.

Frequently asked questions

Is Komzifti approved in Bahrain?

Komzifti is not on NHRA's Registered Medicine Price List (version dated 7 September 2026, 5,560 entries) or on its Temporary Importation Medicines List (dated 19 January 2025). We checked both on 17 October 2026. The same registered list does include other specialty therapies, such as Zolgensma, Casgevy and Elevidys, so it does cover this kind of medicine. NHRA updates its lists. Ask the hospital pharmacy to confirm the current status with NHRA's pharmaceutical products regulation section before anything is filed.

Who applies for permission to use Komzifti in Bahrain?

The treating hospital applies to the National Health Regulatory Authority (NHRA), on the written request of your specialist. Families do not apply on their own, and Reserve Meds does not apply for you.

How long does it take to get Komzifti in Bahrain?

We give you a written timeline estimate once we see the hospital file. The regulator and the manufacturer set their own timelines.

How much does Komzifti cost?

Quote on request. Your total cost, including shipping, import steps and coordination, is quoted in writing for your case before you commit. No hidden charges.

Can Reserve Meds send Komzifti straight to our home?

No. Komzifti goes to the hospital pharmacy named in the approval, which then gives it to the patient. Reserve Meds is a digital health company. Medicines are supplied through a US-licensed pharmaceutical wholesale partner. We are not a pharmacy.

Sources

Checked on 17 October 2026. Regulator rules and lists change. Your hospital pharmacy confirms the current procedure before filing.

  1. The ASCO Post: FDA approves ziftomenib for NPM1-mutated AML, 13 Nov 2025
  2. Targeted Oncology: FDA approves ziftomenib in NPM1-mutant AML (KOMET-001 results)
  3. NHRA Bahrain: Registered Medicine Price List, version dated 7 September 2026 (Excel, 5,560 entries)
  4. NHRA Bahrain: Temporary Importation Medicines List, dated 19 January 2025 (Excel)
  5. NHRA Bahrain: Circular No. (41) of 2020, procedures for importing non-registered medicines and pharmaceutical products
  6. NHRA Bahrain: Application Form for Import of Unregistered Medicines and Pharmaceuticals (14 July 2022)

Related

WhatsApp