Is Ac-225 FDA approved?
3 mins read

Is Ac-225 FDA approved?

Cancer. Just the word itself sends shivers down many spines. Thankfully, science is constantly battling this disease, and new treatments are emerging all the time. One such treatment generating a lot of buzz is actinium-225 (Ac-225). But before we delve into this exciting therapy, let’s address the burning question: is Actinium-225 FDA approved?

Why Choose Actinium-225?

Traditional cancer treatments like chemotherapy and radiation can be effective, but they often come with harsh side effects. Actinium-225 offers a potentially more targeted approach. It’s a type of radioactive material called an alpha emitter. These emitters pack a powerful punch directly to cancer cells, leaving surrounding healthy tissue relatively unharmed.

Types of Actinium-225 Treatments

There are two main ways Actinium-225 is being explored for cancer treatment:

Targeted Alpha Therapy (TAT): Here, Actinium-225 is attached to a molecule that seeks out specific cancer cells. Once attached, the Actinium-225 delivers its radioactive payload directly to the tumor.

Actinium-225/Bismuth-213 Generators: These generators produce a continuous supply of Actinium-225. This is important because Actinium-225 has a short half-life (the time it takes for half the material to decay). Generators ensure a readily available source for treatment.

The Potential Benefits of Actinium-225

The potential benefits of Actinium-225 are quite exciting:

More Targeted: As mentioned earlier, Actinium-225 might offer a more targeted approach compared to traditional treatments, potentially reducing side effects.

Effective Against Resistant Cancers: Some cancers develop resistance to existing therapies. Actinium-225 shows promise in targeting these resistant cancers.

Treating a Variety of Cancers: Researchers are exploring Actinium-225 for treating various cancers, including prostate, brain, and leukemias.

The Road to FDA Approval

Here’s the current status of Actinium-225 and FDA approval:

While Actinium-225 itself isn’t FDA approved yet, it’s definitely on the right track. The FDA has accepted Investigational New Drug (IND) applications for certain Actinium-225-based drugs like 225Ac-FPI-2068 (April 2023). This is a crucial step because it allows for clinical trials, which are essential for gathering data on safety and efficacy.


So, the answer is: Actinium-225 isn’t directly FDA approved yet, but specific drugs incorporating it are undergoing clinical trials, paving the way for potential future approval.


When will Actinium-225 be available for treatment?

This depends on the progress of clinical trials. It could still be a few years before Actinium-225 becomes a widely available treatment option.

Are there any side effects associated with Actinium-225?

As with any treatment, there could be side effects.  Clinical trials will help determine the specific side effects and their severity.

What cancers could be treated with Actinium-225?

Researchers are exploring its use for various cancers, but more research is needed to determine its effectiveness for specific types.


Actinium-225 holds immense promise as a new weapon in the fight against cancer. While it’s not yet FDA approved, the ongoing clinical trials are a positive step towards making it a viable treatment option. With continued research and development, Actinium-225 could soon become a beacon of hope for many cancer patients.