Who Owns Alofisel?

Alofisel's active pharmaceutical ingredient is darvadstrocel, an adipose-derived mesenchymal stem cell preparation. TiGenix, founded in Leuven, Belgium, began developing the compound in the mid-2000s as part of a broader cell therapy program. The rationale was that mesenchymal stem cells have immunomodulatory and tissue-repair properties that could address the chronic fistula tracts that form in a subset of Crohn's disease patients.

The pivotal Phase 3 clinical trial, ADMIRE-CD, enrolled 212 patients across 49 clinical sites in nine countries. The trial measured combined remission at week 24, defined as both clinical remission and the absence of active abscess cavities on MRI. Results published in The Lancet in 2016 showed that 50% of patients in the darvadstrocel group achieved combined remission, compared to 34% in the placebo group, a statistically significant result.

Based on the ADMIRE-CD data, the European Medicines Agency granted marketing authorization for Alofisel in March 2018. This was the first stem cell therapy approved in the European Union for a gastrointestinal indication. Japan's Ministry of Health, Labour and Welfare approved the drug in 2021 under the name Alofisel for the same indication.

Takeda completed its acquisition of TiGenix in April 2019, absorbing Alofisel, TiGenix's manufacturing operations, and the pipeline into its Gastroenterology division. Takeda retained the Alofisel brand name and continued commercialization in the EU markets where it had been launched.

A confirmatory Phase 3 study, ADMIRE-CD II, was required by the EMA as a condition of the initial approval. That trial, involving 569 patients, reported results in 2023. Alofisel failed to meet its primary endpoint of combined remission in that larger study, with results not statistically significantly different from placebo. In December 2024, Takeda voluntarily withdrew Alofisel from the European Union, with no new patients to be treated after December 13, 2024. Existing patients were advised to discuss alternative treatment options with their physicians. As of June 2026, Alofisel is not commercially available in any market.