CEO Michael Raab said that would-be partners for Ardelyx Inc.’s Ibsrela (tenapanor), cleared in September 2019 to treat irritable bowel syndrome with constipation, “don't understand and don't approach the market in the manner that we will,” which is why the company has chosen to launch the sodium/hydrogen exchanger 3 inhibitor on its own in 2022.

The FDA granted 510(k) clearance to Metame Health Inc.’s Regulora, the company’s prescription digital therapeutic (PDT) for abdominal pain associated with irritable bowel syndrome (IBS). Regulora provides gut-directed hypnotherapy in a smartphone app that is designed to help patients better manage their symptoms and address miscommunication between the brain and gut that contributes to sensations of pain.

The digital therapeutics market has seen an explosion of innovative products and interested investors. Regulators, too, have acknowledged their potential to improve outcomes in patients with chronic or debilitating conditions – often at lower cost and with less side effects than traditional drug therapies. To that end, the FDA has granted breakthrough device designation to Swing Therapeutics Inc. for its prescription digital therapeutic for the management of fibromyalgia.

HONG KONG – Shionogi & Co. Ltd. has inked a multitarget drug discovery collaboration for Inveniai LLC’s artificial intelligence and machine learning platform Alphameld. Inveniai is eligible to receive up to $200 million per program through a combination of up-front payments, development and commercial milestones, and royalties.

Mahana Therapeutics Inc. obtained a CE mark for Parallel, a prescription digital therapeutic device to treat irritable bowel syndrome (IBS) in conjunction with other IBS treatments. Developed by a team of U.K. psychologists, the three-month program delivers cognitive behavioral therapy (CBT) via a web-based application.