How to Get Ibudilast for ALS in Poland (before it’s available)

Ketas (ibudilast) is being investigated as a potential treatment for ALS. It's currently in active clinical trials across the USA, Europe, and other regions. Although it has not yet received approval for ALS, it has been granted fast track designation by the FDA and an orphan medicine status by the EMA. These are significant steps towards possible approval in the future.

Here's what you need to know about ibudilast’s approval timeline for ALS and how you can access it in Poland before it’s officially available.

What is Ketas (ibudilast) used for?

Ibudilast was originally developed to treat asthma and post-stroke complications. It has been used in Japan and South Korea for these conditions for years. Recently, its anti-inflammatory and neuroprotective properties have made it a focus of research for neurodegenerative diseases like ALS and multiple sclerosis (MS) ¹.

How does ibudilast work for ALS?

Ibudilast (also known as Ketas or MN-166) is expected to work by targeting multiple mechanisms that contribute to the progression of ALS. It is both an anti-inflammatory and neuroprotective agent, reducing inflammation and protecting nerve cells from damage.

In ALS, chronic inflammation in the brain and spinal cord leads to the death of motor neurons—the cells responsible for muscle movement. Ibudilast helps counteract this process by:

• Suppressing inflammation. It reduces the production of molecules that promote inflammation, such as tumor necrosis factor-alpha (TNF-alpha), interleukin-1 beta (IL-1β), and interleukin-6 (IL-6).
• Inhibiting phosphodiesterase (PDE) enzymes. Specifically, ibudilast blocks PDE-4 and PDE-10, which are linked to inflammatory and neurodegenerative processes in the nervous system.
• Reducing glial cell activity. Glial cells are key players in neuroinflammation. When overactivated, they contribute to the damage of motor neurons. Ibudilast helps modulate their activity, reducing their harmful effects.
• Promoting neuroprotection and nerve repair. By reducing inflammation and oxidative stress, ibudilast creates a more favorable environment for nerve cell survival and function.

In clinical trials, ibudilast has shown potential in improving functional measures and slowing the progression of ALS, especially in early-stage patients ¹.

A Phase 2b/3 trial called COMBAT-ALS is currently ongoing. It focuses on comparing changes in the ALSFRS-R scores of ALS patients after one year of treatment with ibudilast. Primary results are expected in December 2025, and the study will finalize in December 2026 ².

Where is ibudilast approved?

As of February 2025, ibudilast (Ketas, MN-166) is approved in the following countries:

• Japan: Approved for the treatment of asthma and post-stroke dizziness (cerebrovascular disorders).
• South Korea: Approved for asthma treatment.

While ibudilast shows promise in clinical trials for ALS and multiple sclerosis (MS), it has not been approved for these conditions in any country yet. However, it has received:

• Fast track and orphan drug designations from the U.S. FDA for ALS.
• Orphan drug designation from the EMA for ALS.

Regulatory approvals for neurodegenerative diseases like ALS could follow if ongoing clinical trials (such as the COMBAT-ALS trial) show positive results.

Can my doctor prescribe ibudilast for ALS?

Technically, yes. Your treating doctor in Poland could make this decision on the basis of existing clinical trial results. Or, following a consultation with other doctors who have used the medicine in their clinical practice.

When a doctor prescribes a medicine for treating a disease it's not approved for (yet), that's called off-label use.

Where to get ibudilast in Poland before it's approved

If you or a loved one needs ibudilast for ALS, you don’t have to wait for regulatory approval in Poland. There are two main ways to access it:

• Join a clinical trial

Participating in a clinical trial is one way to access ibudilast. The ongoing COMBAT-ALS trial is recruiting patients in the U.S. and Canada. While it may not be open to patients from Poland, there are other trials worth exploring. You can check ClinicalTrials.gov for a comprehensive list of available trials.

• Order Ibudilast for personal use

If you can’t join a clinical trial or need ibudilast urgently, you are allowed to buy the medicine from abroad for personal use. This process is called Named Patient Import. In order to get ibudilast in Poland via Named Patient Import, you will need a prescription from your doctor.

What is the price of ibudilast in Poland?

The final price of a medicine that isn't locally available can vary based on supplier, your location, and any shortages. However, as a general idea, the price of one package of Ketas (ibudilast), containing 500 capsules of 10 mg, is approximately EUR 440 ³. This amount is typically sufficient for about 80 days of treatment.

How Named Patient Import works

• Consult your doctor. If your doctor agrees that ibudilast could be beneficial for you, they can issue a prescription.
• Order your medicine via Everyone.org. At Everyone.org, we specialize in Named Patient Import. Our expert Medicine Access team can help you navigate the process of importing ibudilast to Poland.
• Receive your medicine. After confirming your prescription and completing the necessary paperwork, we’ll help arrange the delivery of the medicine to you.

Although ibudilast is not yet available for ALS in Poland, you don’t have to wait. If you have a prescription for the medicine, share it with our team and let us help you get the medicine you need, when you need it. Get started via the button below.

References:

1. MN-166 for ALS. ALSNewstoday, Accessed 13 February 2025.
2. Evaluation of MN-166 (ibudilast) for 12 Months Followed by an Open-label Extension for 6 Months in Patients with ALS (COMBAT-ALS). ClinicalTrials.gov, Accessed 13 February 2025.
3. Buy Ketas (ibudilast) Online • Price & Costs. Everyone.org, Accessed 13 February 2025.