Kailera, holding $1.04bn, readies late-stage trials of oral obesity drug ribupatide

Kailera Therapeutics plans to begin a global late-stage clinical programme for oral ribupatide, its GLP-1-based obesity candidate, in the first half of 2027. The company said on 4 November that it has now held its end-of-phase-2 meeting with the US Food and Drug Administration, the usual checkpoint before pivotal studies.

The company gave the news with its third-quarter results. It reported $1.04bn in cash and said that would cover its operating costs until the middle of 2028. That runway extends beyond the planned start of the oral programme, though Kailera has not said how much the pivotal trials will cost or how long they will run.

Kailera also said it has finished recruiting patients for three studies: the Phase 2b and Phase 3 trials of injectable ribupatide, and a Phase 2 trial of safiglipron. In addition, the investigational new drug application for KAI-4729 is now active, so the US clinical work on that candidate can proceed.

The update leaves several points open. The company has not disclosed the design or size of the oral ribupatide trials, what the FDA said in the meeting beyond the decision to go ahead, or when data from the fully enrolled studies will be available.

As context, obesity is one of the most closely watched areas in drug development, and oral GLP-1-type treatments are being pursued by a number of developers.