Is Alofisel a subsidiary of Takeda?

Alofisel is not a subsidiary; it is a pharmaceutical product wholly owned by Takeda Pharmaceutical Company. Takeda acquired it through the 2019 purchase of TiGenix NV, the Belgian biotech that developed the darvadstrocel compound. The product has been withdrawn from commercial sale as of December 2024.

Is Alofisel publicly traded?

Alofisel is not a publicly traded entity. Takeda Pharmaceutical Company, the owner, trades on the Tokyo Stock Exchange under ticker 4502 and on the NYSE under ticker TAK. Investors in Takeda hold indirect exposure to all of Takeda's products, including any residual Alofisel-related assets.

Who developed Alofisel?

Alofisel was developed by TiGenix NV, a Belgian cell therapy company based in Leuven, Belgium. TiGenix ran the pivotal ADMIRE-CD Phase 3 trial that supported the EMA approval. Takeda acquired TiGenix in 2019 for approximately €520 million, at which point it took ownership of the product.

What was Alofisel's market position?

Alofisel was the first stem cell therapy approved in the European Union for a gastrointestinal indication. It occupied a narrow market niche targeting Crohn's disease patients with complex perianal fistulas who had failed conventional and biologic therapies. Pricing was in the range of €60,000 to €90,000 per treatment course in some markets, and reimbursement was limited to a small number of EU member states.

Why was Alofisel withdrawn from the market?

The ADMIRE-CD II confirmatory Phase 3 trial, completed in 2023, failed to demonstrate a statistically significant improvement over placebo on the primary endpoint of combined remission at 24 weeks. Without confirmatory efficacy evidence, Takeda determined that continued commercialization was not viable and voluntarily withdrew the EU marketing authorization in December 2024.

Healthcare & Pharmaceuticals

Who Owns Alofisel?

Q: When was Alofisel approved and when was it withdrawn?

Alofisel received European Medicines Agency marketing authorization in March 2018 and was approved in Japan in 2021. Takeda voluntarily withdrew the EU marketing authorization effective December 13, 2024, following the failure of the ADMIRE-CD II confirmatory trial to meet its primary endpoint.

Alofisel is owned by Takeda Pharmaceutical Company (TSE: 4502; NYSE: TAK), a publicly traded Japanese multinational pharmaceutical company headquartered in Tokyo, Japan. Takeda acquired Alofisel through its 2019 acquisition of TiGenix, the Belgian biotech that originally developed the therapy. Alofisel was voluntarily withdrawn from the European Union market in December 2024 following Phase 3 confirmatory trial failures.

Parent Company

Takeda Pharmaceutical Company

Acquired

2019

Status

Publicly Traded

Headquarters

Tokyo, Japan

Alofisel Timeline

1781

Takeda Pharmaceutical Company

Parent company established in Tokyo, Japan

Company Founded

2018

Alofisel

Founded by TiGenix

Founded

2019

Acquired by Takeda Pharmaceutical Company

Takeda Pharmaceutical Company acquired Alofisel

Acquired

EuropeOfficial Website

Who Owns Alofisel?

Parent Company: Takeda Pharmaceutical Company
Ownership Type: Wholly owned
Acquisition Year: 2019
Company Type: Publicly Traded
Stock Ticker: Tokyo Stock Exchange; New York Stock Exchange (ADR): 4502 (TSE); TAK (NYSE ADR)

Brand	Parent Company	Ownership Type
Alofisel	Takeda Pharmaceutical Company	Wholly owned

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Alofisel on Amazon

History of Alofisel

Founded: 2018
Founders: TiGenix
Acquired by Takeda Pharmaceutical Company: 2019

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.

About Takeda Pharmaceutical Company

What does Takeda make?
Takeda makes prescription pharmaceuticals across six therapeutic areas: gastroenterology (Entyvio, Dexilant), oncology (Ninlaro, Adcetris), neuroscience (Vyvanse, Trintellix, Rozerem), rare diseases (TAKHZYRO), plasma-derived therapies (GAMMAGARD LIQUID), and immunology. The company has three major pipeline products pending launch: oveporexton for narcolepsy type 1, rusfertide for polycythemia vera, and zasocitinib for psoriasis.

Is Takeda publicly traded?
Yes, Takeda Pharmaceutical Company Limited is listed on the Tokyo Stock Exchange under ticker 4502 and on the NYSE as an ADR under ticker TAK. The company also trades on the Nagoya, Sapporo, and Fukuoka stock exchanges. The company has a broad institutional and retail shareholder base with no single controlling shareholder.

Who is Takeda's CEO?
Julie Kim serves as CEO-elect, succeeding Christophe Weber, who served as President and CEO since 2014. Kim previously led Takeda's Plasma-Derived Therapies business unit. Weber's leadership included the transformative Shire acquisition in 2019. Kim is expected to outline her longer-term strategy at a capital markets day.

What is Takeda's revenue?
For FY2025 (ended March 31, 2026), Takeda reported revenue of JPY 4,505.7 billion (approximately $28.3 billion), a 1.7% decline at actual exchange rates. Core Operating Profit was JPY 1,172.5 billion (approximately $7.4 billion). The company reported a net loss of JPY 152.4 billion due to additional legal provisions and impairment losses. For FY2026, Takeda forecasts revenue of JPY 4,640.0 billion.

Who founded Takeda?
Takeda was founded in 1781 in Osaka, Japan by Chobei Takeda, who established a business selling traditional Japanese and Chinese medicines. The company has been in continuous operation for over 240 years, making it one of the world's oldest pharmaceutical companies.

Where is Takeda headquartered?
Takeda is headquartered in Tokyo, Japan. The company's global operations span more than 80 countries, with its largest market being the United States. Takeda also has major operations in Europe, Japan, and emerging markets.

How many employees does Takeda have?
Takeda employs approximately 50,000 people worldwide. The company's workforce is distributed across research and development, manufacturing, and commercial operations in more than 80 countries.

What are Takeda's major pipeline products?
Takeda's three leading late-stage assets are oveporexton (for narcolepsy type 1, launching H2 2026 with FDA Priority Review), rusfertide (for polycythemia vera, launching H2 2026 with FDA Priority Review), and zasocitinib (for psoriasis, launching H1 2027). The company also has Phase 3 programs for elritercept, mezagitamab, and TAK-881.

Founded: 1781
Headquarters: Tokyo, Japan
Company Type: Publicly Traded
Stock: Tokyo Stock Exchange; New York Stock Exchange (ADR): 4502 (TSE); TAK (NYSE ADR)
Revenue: JPY 4,505.7 billion (FY2025, approximately $28.3 billion)
Employees: approximately 50,000

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Where Is Alofisel Made / Based?

Headquarters: Tokyo, Japan
Manufacturing / Operations: Belgium

Alofisel Categories & Tags

Gastroenterology Crohns Disease Fistula Cell Therapy Prescription

Alofisel Recalls & Controversies

ADMIRE-CD II Trial Failure (2023): The confirmatory Phase 3 trial required by the EMA as a condition of approval enrolled 569 patients across multiple sites. The primary endpoint was combined remission at 24 weeks. Alofisel did not achieve a statistically significant difference from placebo. This was the most consequential setback for the product, as it called into question whether the positive ADMIRE-CD results reflected a durable therapeutic effect or were influenced by the characteristics of the smaller, more controlled original trial population. The outcome is not considered a recall or regulatory sanction; it is a clinical trial result. The EMA did not find any safety violations associated with the withdrawal.

EU Market Withdrawal (December 2024): Takeda voluntarily withdrew the EU marketing authorization effective December 13, 2024. The withdrawal was Takeda's decision and was not initiated by the EMA as a punitive action. Physicians treating existing Alofisel patients were informed to transition them to alternative therapies. The withdrawal had no finding of product safety defects or manufacturing violations.

Cell Therapy Platform Reassessment: Following the withdrawal, Takeda announced in early 2025 that it would seek external partners or licensing arrangements for its remaining cell therapy platform technologies, rather than continuing internal commercialization of cell-based products. This represents a strategic exit from the cell therapy segment for Takeda, at least in the near term.

Alofisel Ownership: Pros & Cons

Advantages

+Takeda's global regulatory infrastructure supported EMA approval and Japan approval for a complex cell therapy product
+Takeda's financial resources funded the large ADMIRE-CD II confirmatory trial that provided definitive efficacy data
+Takeda's manufacturing experience allowed it to sustain cold-chain logistics for a biologically fragile product across European markets
+The acquisition of TiGenix gave Takeda cell therapy manufacturing capabilities and intellectual property with broader platform potential
+Takeda's Gastroenterology division provided commercial infrastructure to reach IBD specialists in EU markets

Considerations

-ADMIRE-CD II trial failure confirmed that the initial Phase 3 results did not replicate in a larger population, eliminating the commercial case for continuation
-Voluntary EU withdrawal in December 2024 ends Alofisel's availability and strands patients who were using or awaiting the therapy
-High manufacturing cost and complex cold-chain logistics reduced profitability even in markets where reimbursement was obtained
-Limited reimbursement coverage across EU markets reduced patient access during the product's commercial life
-The Alofisel setback has contributed to Takeda's decision to exit direct cell therapy commercialization

Frequently Asked Questions About Alofisel

Sources & Further Reading

Competitors to Alofisel

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Brand	Parent Company	Country	Founded	Market Position	Primary Market	Gender Target
DexilantSister Brand	Takeda	Japan	2009	Mass market	United states	All Genders
EntyvioSister Brand	Takeda	Japan	2014	Mass market	Global	All Genders