Takeda has ended development of its nausea and vomiting drug candidate for strategic reasons, continuing its multi-year struggles in the therapeutic area.
The nausea and vomiting prospect, TAK-004, completed a phase 1 trial last year. Takeda ran the study to evaluate the safety and tolerability of the investigational peptide agonist while evaluating its effect on the heart rate and blood pressure of healthy adults. The Japanese drugmaker named assessing whether TAK-004 causes an immune response as another objective of the trial.
Takeda removed (PDF) the drug candidate from its pipeline as part of its fourth-quarter results, telling investors that it ended TAK-004 development “due to strategic consideration.” The company’s strategy has veered away from nausea and vomiting in recent years.
At the start of 2022, Takeda was developing (PDF) three peptide agonists—TAK-105, TAK-510 and TAK-951—in nausea and vomiting, plus its gastroparesis candidate TAK-906. Takeda stopped (PDF) work on the treatment for gastroparesis, a condition associated with nausea and vomiting, early in 2022 in response to phase 2b data.
The drugmaker ended (PDF) development of TAK-510 in late 2022 after concluding that the phase 1 data didn’t support further trials. Takeda reached (PDF) the same conclusion about TAK-105 in 2023. Work on the phase 2 candidate TAK-951 continued into 2024. However, in May 2024, Takeda axed the program after the clinical data failed to support further development.
The removal of TAK-951 from the pipeline left Takeda without a program targeting nausea and vomiting for the first time in years. Takeda moved (PDF) TAK-004 into human testing in late 2024, re-entering nausea and vomiting clinical development, but the candidate had the same fate as its predecessors. Takeda continues "to have interest in nausea and vomiting where we see meaningful unmet need," a spokesperson said via email.
The drugmaker disclosed the discontinuation of TAK-004 development alongside other pipeline updates. The Japanese pharma removed the 5% formulation of TAK-961, its late-phase autoimmune encephalitis candidate, from the pipeline but still plans to seek approval for the 10% product. Data on the 5% formulation will support approval filings for the 10% product, the company said.
Takeda removed the Denali Therapeutics-partnered frontotemporal dementia candidate, TAK-594, from its pipeline after ending its alliance with the biotech. The other updates affected approved products, with Takeda ending a booster program for its dengue vaccine Qdenga in light of durability data and axing a proposed indication for the enzyme replacement therapy Adzynma for strategic reasons.