Is Oral VK2735 Approved? June 2026 Phase 2 Status
Trial status, VENTURE-Oral Phase 2 data, the subcutaneous VANQUISH program, and what to watch next for Viking Therapeutics’ dual GLP-1/GIP receptor agonist.
Update History ▾
May 25, 2026: Re-checked the May 12 ECO 2026 VENTURE-Oral dataset and refreshed approval status, verdict, takeaways, status table, and FAQ/schema to May 25. VK2735 remains investigational; oral Phase 3 is planned later in 2026, not filed.
May 18, 2026: Added May 2026 research update on full 13-week VENTURE-2 oral VK2735 dataset presented at ECO 2026 (May 12).
May 17, 2026: Corrected stale “both unapproved as of March 2026” framing in two places — orforglipron was FDA-approved as Foundayo on April 1, 2026 (EDE-approved for the UAE on April 3, 2026). VK2735 remains investigational. Refreshed competitive-landscape framing.
March 9, 2026: Latest data review and formatting update
Initial publication
No. As of June 1, 2026, oral VK2735 is not approved by the FDA or any other regulatory agency. Viking Therapeutics presented the full 13-week Phase 2 VENTURE-Oral dataset at ECO 2026 on May 12, 2026: the 120 mg cohort showed 12.2% mean body-weight reduction at 13 weeks versus 1.3% on placebo, with no plateau through week 13. Viking says oral Phase 3 tablet trials are planned later in 2026, while the subcutaneous formulation is already in Phase 3 (VANQUISH-1 and VANQUISH-2). No FDA submission has been filed. For the master status view, use the Approval Trackers hub.
Research-use supply note: Regulatory tracking is separate from lab supply. VK2735 remains investigational and is not supplied by Remy Peptides. This approval tracker is evidence and regulatory context, not a pharmacy or treatment guide. For separate UAE in-vitro laboratory supply context, see Retatrutide UAE, verified UAE researcher reviews, and wholesale pricing for qualified lab or distributor inquiries.
- Oral VK2735 is not approved as of June 1, 2026.
- Phase 2 VENTURE-Oral data presented at ECO 2026: up to 12.2% weight loss at 13 weeks in 280 adults.
- The 120 mg cohort reached 12.2% mean body-weight reduction vs 1.3% on placebo; 80% achieved at least 10% weight loss.
- VK2735 is a dual GLP-1/GIP receptor agonist — available in both oral and subcutaneous formulations.
- Subcutaneous Phase 3 trials (VANQUISH-1, VANQUISH-2) are now both fully enrolled (VANQUISH-2 Mar 26, 2026; VANQUISH-1 per the Apr 29, 2026 Q1 report), with readouts expected in 2027; oral tablet Phase 3 is planned later in 2026.
- No FDA submission date has been publicly announced by Viking Therapeutics.
| Item | Status (June 1, 2026) |
|---|---|
| FDA Approval | Not approved |
| Clinical Stage (Oral) | Phase 2 complete (VENTURE-Oral) |
| Clinical Stage (Subcut.) | Phase 3 — VANQUISH-1 & -2 fully enrolled; readouts expected 2027 |
| Best Weight-Loss Figure (Oral) | 12.2% at 13 weeks |
| Best Weight-Loss Figure (Subcut.) | 14.7% at 13 weeks (Phase 2) |
| Developer | Viking Therapeutics |
| Drug Type | Dual GLP-1/GIP receptor agonist |
| Dosing (Oral) | Once daily tablet |
| FDA Submission Date | Not filed |
| Expected Approval Date | Not publicly disclosed |
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?
Viking Therapeutics' VENTURE-Oral Phase 2 trial enrolled 280 adults with obesity or overweight in a 13-week randomized, double-blind, placebo-controlled design. Viking presented the complete dataset at ECO 2026 on May 12. The headline figure: the 120 mg cohort reached 12.2% mean body weight reduction from baseline at 13 weeks, compared with 1.3% on placebo.
Viking reported that most treatment-emergent adverse events were mild or moderate, and that gastrointestinal events were the most common. The May 2026 ECO update also showed a clean dose response: 30 mg at −7.0%, 60 mg at −8.7%, 90 mg at −11.1%, and 120 mg at −12.2% at week 13.
The weight-loss curve had not plateaued by week 13, which is why the oral program remains a high-interest pipeline asset. Viking stated that it expects to initiate Phase 3 oral tablet trials later in 2026. See our best retatrutide supplier Dubai guide for context on where VK2735 fits in the broader pipeline.
Viking presented the complete 13-week VENTURE-2 dataset for oral VK2735 at ECO 2026 in Istanbul on May 12, 2026. The 120-mg cohort posted 12.2% mean weight reduction at 13 weeks vs 1.3% placebo (Δ −10.9%, P<0.0001), with 80% of subjects achieving at least 10% weight loss and up to 97% reaching at least 5%. The dose-response was clean (90 mg = −11.1%, 60 mg = −8.7%, 30 mg = −7.0%) and the weight curve showed no plateau through week 13. Viking confirmed the Phase 3 oral VK2735 tablet program initiation is planned for later in 2026.
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. Both are now fully enrolled — VANQUISH-2 completed enrollment on March 26, 2026, and VANQUISH-1 was reported fully enrolled in Viking's Q1 2026 results on April 29, 2026. Both Phase 3 readouts are expected in 2027 and 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 Phase 3 initiation. Viking said on May 12, 2026 that it expects to initiate Phase 3 trials with the oral tablet later in 2026. The next watch item is the trial-design announcement: dose range, titration design, duration, endpoints, and whether the registration package mirrors the subcutaneous VANQUISH program.
3. Competitive landscape. The oral obesity drug market is evolving rapidly. The Wegovy pill is FDA approved, and orforglipron (Eli Lilly) was FDA-approved as Foundayo on April 1, 2026 (and EDE-approved for the UAE in early April 2026). 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.
The May 2026 VENTURE-Oral update moved VK2735 from a short Phase 2 signal into a live oral-registration watch item. The 12.2% weight loss at 13 weeks is not directly comparable to longer pivotal trials for Foundayo or oral semaglutide, but the no-plateau trajectory gives Viking a plausible Phase 3 rationale. Track all key milestones on our Approval Trackers hub and the 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.
| Feature | Oral VK2735 | Orforglipron | Wegovy Pill |
|---|---|---|---|
| Status (June 1, 2026) | Not approved (Phase 2 complete; oral Phase 3 planned) | FDA approved; UAE EDE approved | FDA approved |
| Drug Type | Dual GLP-1/GIP agonist | Non-peptide GLP-1 agonist | Peptide oral semaglutide |
| Developer | Viking Therapeutics | Eli Lilly | Novo Nordisk |
| Best Weight-Loss Figure | 12.2% at 13 weeks | 12.4% at 72 weeks | 16.6% (OASIS 4) |
| Dosing | Once daily | Once daily, no restrictions | Once daily, fasting required |
| Key Safety Concern | GI events; Phase 3 tolerability pending | — | Fasting/water restrictions |
Our Research Standards
This article cites peer-reviewed studies, FDA filings, and ClinicalTrials.gov data. All claims are cross-referenced against primary sources. We update articles when new trial data or regulatory decisions are published. Read our editorial policy →
- Viking Therapeutics. VENTURE-Oral Phase 2 results. August 2025. ir.vikingtherapeutics.com
- Viking Therapeutics. VENTURE Phase 2 publication in journal Obesity. prnewswire.com
- ClinicalTrials.gov. VK2735 Phase 2 (NCT06068946). clinicaltrials.gov
- Viking Therapeutics pipeline. vikingtherapeutics.com
- Viking Therapeutics. Full 13-week VENTURE-2 Phase 2 oral VK2735 data presented at ECO 2026. May 12, 2026. ir.vikingtherapeutics.com
- Viking Therapeutics. VANQUISH-2 enrollment completed (March 26, 2026); VANQUISH-1 fully enrolled per Q1 2026 results (April 29, 2026); both Phase 3 readouts expected 2027. ir.vikingtherapeutics.com