FDA-Approved Pill Tracks Patient Ingestion of Medication

The U.S. Food and Drug Administration (FDA) has approved Abilify MyCite (aripiprazole tablets with sensor), a pill that digitally tracks if patients have ingested their medication. Abilify MyCite is the first drug in the U.S. with a digital ingestion tracking system and has an ingestible sensor embedded in it that records that the medication was taken. The product has been approved for the treatment of schizophrenia, acute treatment of manic and mixed episodes associated with bipolar I disorder and for use as an add-on treatment for depression in adults.

Abilify MyCite is manufactured by Otsuka Pharmaceutical Co., Ltd. (Tokyo, Japan), while the sensor technology and patch are made by Proteus Digital Health (Redwood City, CA).


The system works by sending a message from the pill’s sensor to a wearable patch, which transmits the information to a mobile application to allow patients to track the ingestion of the medication on their smart phone. Patients can also permit their caregivers and physician to access the information through a web-based portal.

“Being able to track ingestion of medications prescribed for mental illness may be useful for some patients,” said Mitchell Mathis, M.D., director of the Division of Psychiatry Products in the FDA’s Center for Drug Evaluation and Research. “The FDA supports the development and use of new technology in prescription drugs and is committed to working with companies to understand how technology might benefit patients and prescribers.”

Related Links:
Otsuka Pharmaceutical
Proteus Digital Health