Viking Therapeutics Advances VK2735 Toward Phase 3 After FDA Feedback

VK2735 acts as a dual agonist of the GLP-1 and GIP receptors—the same mechanism leveraged by several successful injectable therapies. Viking is pursuing two concurrent paths: a subcutaneous injectable formulation and the oral tablet, with the latter potentially broadening patient appeal.

Phase-3 initiation for the oral version is targeted for the third quarter of 2026, following favorable feedback from the U.S. Food and Drug Administration. This places Viking among a select group with a late-stage oral obesity candidate in a lucrative market.

Earlier Phase-2 data indicated the tablet produces meaningful body-weight reduction and demonstrated a tolerability profile comparable to other GLP-1 therapies.

The injectable program continues to advance in parallel. Recruitment for VANQUISH-1, Viking’s first pivotal Phase-3 study, is finished, while VANQUISH-2 is approaching full patient enrollment. A separate maintenance-dosing study is underway, with results expected in the third quarter of 2026. That study evaluates different regimens—including monthly injections as well as weekly or daily oral dosing—to optimize long-term weight management.

Beyond VK2735, Viking is expanding its pipeline. In the first quarter of 2026, the company aims to file an Investigational New Drug application for a novel dual Amylin- and Calcitonin-Receptor Agonist (DACRA). This mechanism could serve as a complementary approach to GLP-1 therapies.

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Finances and quarterly performance:

• As of December 31, 2025, Viking held cash and cash equivalents of $706 million. These funds are intended to support the capital-intensive Phase-3 programs during the year.

• In Q4 2025, the company posted a net loss of $157.7 million. Research and development expenses amounted to $153.5 million, driven by the multiple late-stage studies in progress.

Key facts at a glance:
- Phase-3 initiation for the oral VK2735 in Q3 2026 is planned
- VANQUISH-1 recruitment is complete; VANQUISH-2 is nearing full enrollment
- DACRA IND submission targeted for Q1 2026
- Cash balance: $706 million as of 12/31/2025
- Q4 2025 net loss of $157.7 million and R&D expenses of $153.5 million

With the anticipated Phase-3 start for the oral formulation in the coming quarter, Viking faces a critical six-month window. The readouts from the maintenance-dosing study in the same period should further illuminate the company’s commercial trajectory.