Is Oral VK2735 Approved Yet?

What Is VK2735?

VK2735 is Viking Therapeutics’ dual GLP-1/GIP receptor agonist being developed for obesity in both subcutaneous (injectable) and oral tablet formulations. By targeting two incretin receptors — GLP-1 and GIP — VK2735 uses a dual-agonist mechanism that differentiates it from single-target GLP-1 drugs like semaglutide and orforglipron.

The dual-agonist approach is shared by tirzepatide (Eli Lilly’s Mounjaro/Zepbound), which also targets GLP-1 and GIP receptors. Viking is developing VK2735 as a potential competitor in this dual-agonist space, with the oral formulation representing an attempt to deliver dual-agonist efficacy in a pill format. For a broader look at the oral obesity landscape, see our overview of oral obesity drugs in 2026.

What Did the VENTURE-Oral Phase 2 Trial Show?

In August 2025, Viking Therapeutics reported results from the VENTURE-Oral Phase 2 trial. The study enrolled 280 adults with obesity or overweight in a 13-week randomized, double-blind, placebo-controlled design. The headline figure: up to 12.2% mean body weight reduction from baseline at 13 weeks.

Most adverse events were mild to moderate, primarily gastrointestinal in nature. However, the trial recorded a 28% dropout rate, with discontinuations largely attributed to GI side effects. This tolerability signal concerned investors and analysts — Viking’s stock dropped approximately 37% following the data release.

The weight loss itself was notable for a 13-week oral trial, but the dropout rate raised questions about whether the oral formulation can achieve acceptable tolerability for a broader patient population. These tolerability concerns will likely shape the design and endpoints of any subsequent oral trials. See our best research peptides guide for 2026 for context on where VK2735 fits in the broader pipeline.

What About the Subcutaneous Program?

The subcutaneous (injectable) VK2735 program is further along in development. Phase 2 data from the VENTURE trial, published in the journal Obesity, showed up to 14.7% weight loss at 13 weeks — a stronger efficacy signal than the oral formulation.

Viking Therapeutics has advanced the subcutaneous program into Phase 3 with two pivotal trials: VANQUISH-1 and VANQUISH-2. VANQUISH-1 over-enrolled ahead of schedule, and VANQUISH-2 was expected to complete enrollment in Q1 2026. These Phase 3 readouts will be critical for any potential regulatory submission.

What Happens Next?

Three developments define the near-term path for VK2735:

1. Phase 3 subcutaneous readouts. The VANQUISH-1 and VANQUISH-2 trials will generate the pivotal data needed for a potential FDA submission of the injectable formulation. These readouts are the most important near-term catalysts for Viking Therapeutics.

2. Oral program decisions. Viking has not publicly detailed the next steps for the oral VK2735 program beyond the completed Phase 2 trial. The 28% dropout rate suggests that dose optimization or formulation adjustments may be needed before advancing to Phase 3. Whether and when Viking pursues a larger oral trial remains an open question.

3. Competitive landscape. The oral obesity drug market is evolving rapidly. The Wegovy pill is already FDA approved, and orforglipron (Eli Lilly) has completed Phase 3. Oral VK2735 would need to demonstrate a clear efficacy or tolerability advantage to carve out a competitive position in an increasingly crowded space. We explore this question in depth in our analysis of oral obesity drugs in 2026.

Why Does This Matter Now?

VK2735 is one of the few dual GLP-1/GIP agonists being developed in an oral format, which makes it a unique entry in the obesity pipeline. The dual-agonist mechanism has already been validated by tirzepatide’s commercial success, and delivering that mechanism in a pill would be a meaningful advance.

However, the VENTURE-Oral tolerability data introduced uncertainty. The 12.2% weight loss at 13 weeks was promising, but a 28% dropout rate is difficult to overlook in a short trial. The path forward for the oral program depends on whether Viking can address these GI tolerability concerns in subsequent development. Track all key milestones on our obesity drug approval tracker for 2026.

Meanwhile, the subcutaneous VANQUISH program is the more likely near-term path to market for VK2735. Researchers tracking the obesity drug pipeline should monitor both the Phase 3 injectable readouts and any announcements regarding the oral program’s next steps. For a comparison of the leading injectable candidates, see our retatrutide vs tirzepatide vs CagriSema analysis.