VK2735Viking TherapeuticsFDA Timeline

Phase 3 VANQUISH program timeline, projected FDA approval dates, and regulatory pathway for VK2735

Quick Take

Current FDA Status

  • Phase 3 trials ongoing: Viking Therapeutics initiated the VANQUISH Phase 3 program in June 2025 for VK2735—a dual GLP-1/GIP receptor agonist
  • VANQUISH-1 enrollment complete: ~4,650 patients enrolled (completed November 2025) for obesity indication, 78-week treatment period[1]
  • VANQUISH-2 enrolling: ~1,100 patients with type 2 diabetes + obesity, enrollment expected Q1 2026[4]
  • Phase 2 results: 14.7% weight loss at 13 weeks (injectable)[2], 12.2% at 13 weeks (oral tablet)[3]
  • FDA decision timeline: Projected 2028-2029 (assuming Phase 3 success and standard review)
Phase 1
2022-2023

Safety established

Phase 2
2023-2025

14.7% weight loss

Phase 3
2025-2027

VANQUISH program

NDA Filing
~2027

Application to FDA

FDA Decision
2028-2029

Expected approval

Current Trials

VANQUISH Phase 3 Program

Viking Therapeutics launched the VANQUISH Phase 3 program in June 2025 to support FDA approval of VK2735:

VANQUISH-1 (Obesity)[1]

  • Population: ~4,650 adults with obesity (BMI ≥30) or overweight (BMI ≥27) with weight-related comorbidities
  • Enrollment status: Completed November 2025 (ahead of schedule)
  • Duration: 78-week treatment period + 52-week extension
  • Doses: VK2735 7.5mg, 12.5mg, 17.5mg weekly vs. placebo
  • Primary endpoint: Percent change in body weight from baseline at 78 weeks
  • Results expected: Late 2027

VANQUISH-2 (Type 2 Diabetes)[4]

  • Population: ~1,100 adults with obesity/overweight AND type 2 diabetes
  • Enrollment status: Currently enrolling, expected completion Q1 2026
  • Duration: 78 weeks
  • Significance: If successful, would support diabetes indication and Medicare Part D coverage

Rapid Enrollment

Viking announced that VANQUISH-1 enrollment completed ahead of schedule and exceeded the target size—indicating strong patient and investigator interest in VK2735. This rapid enrollment is a positive signal for the drug's commercial potential.

Key Milestones

Development Timeline

PhaseStatusTimeframeDescription
Phase 1 (Injectable)✓ Complete2022-2023Up to 18 lbs weight loss in 28 days
Phase 2 VENTURE (Injectable)✓ Complete2023-202414.7% weight loss at 13 weeks
Phase 1 MAD (Oral)✓ Complete2023-2024Oral tablet safety and dosing
Phase 2 VENTURE-Oral✓ Complete202512.2% weight loss at 13 weeks
Phase 3 VANQUISH-1⟳ Ongoing2025-202778-week obesity trial, enrollment complete
Phase 3 VANQUISH-2⟳ Enrolling2025-2027Type 2 diabetes population
NDA Submission⧗ Pending~2027Post Phase 3 results
FDA Decision⊕ Projected2028-2029Assuming standard review
Timeline Scenarios

Approval Predictions

Best-Case Scenario

Probability: Lower

Timeline: Early 2028 approval

What would need to happen:

  • VANQUISH-1 results by mid-2027 (78 weeks from Nov 2025)
  • Immediate NDA filing with strong data
  • Priority Review granted (6 months)
  • No FDA questions or manufacturing issues

Most Likely Scenario

Probability: Higher

Timeline: Mid-to-late 2028 approval

Assumptions:

  • VANQUISH-1 results Q3-Q4 2027
  • NDA filing late 2027 or early 2028
  • Standard review (10-12 months)
  • Approval H2 2028

Delayed Scenario

Probability: Moderate

Timeline: 2029 or later

Potential causes:

  • Phase 3 safety signals requiring additional data
  • Manufacturing scale-up challenges (Viking is a small biotech)
  • FDA requests cardiovascular outcomes study
  • Complete Response Letter requiring resubmission

Summary for Readers: VK2735 is earlier in development than CagriSema or retatrutide. The most realistic approval timeline is mid-to-late 2028, with potential for delays if Phase 3 results are less compelling than Phase 2 or if manufacturing challenges emerge.

VK2735 FDA TIMELINE QUESTIONS

FAQs

Based on the current development timeline, VK2735 FDA approval is projected for 2028-2029. The VANQUISH-1 Phase 3 trial (78 weeks) with enrollment completed in November 2025 means results will be available in late 2027. NDA filing and FDA review would follow, targeting approval in 2028.

No. VK2735 is not yet FDA-approved and is only available through clinical trial participation. Check ClinicalTrials.gov for the VANQUISH program trials—VANQUISH-2 (type 2 diabetes population) may still be enrolling through Q1 2026.

VK2735 is behind several competitors in the approval race:

  • Zepbound (tirzepatide): Already FDA-approved (2023)
  • CagriSema: NDA filing expected Q1 2026, approval late 2026/2027
  • Retatrutide: Phase 3 ongoing, approval expected 2027-2028
  • VK2735: Phase 3 ongoing, approval expected 2028-2029

Viking is a smaller company than Eli Lilly or Novo Nordisk, which may affect the timeline for manufacturing scale-up and commercial launch.

This is a valid concern. Viking Therapeutics is a small biotech company without existing commercial infrastructure. Options for market launch include:

  • Partnership: License VK2735 to a larger pharmaceutical company for commercialization
  • Acquisition: A larger company could acquire Viking outright
  • Build internally: Viking could raise capital to build its own commercial organization

Viking's strong Phase 2 data makes it an attractive acquisition or partnership target. Many successful obesity drugs have been developed by small biotechs and commercialized by larger partners.

Sources & References

  1. Viking Therapeutics. "Completion of Enrollment in Phase 3 VANQUISH-1 Trial." November 2025. https://ir.vikingtherapeutics.com/news-releases
  2. Viking Therapeutics. "Positive Top-Line Results from Phase 2 VENTURE Trial." February 2024. https://ir.vikingtherapeutics.com/news-releases/news-release-details/viking-therapeutics-announces-positive-top-line-results-phase-2
  3. Viking Therapeutics. "Positive Top-Line Results from Phase 2 VENTURE-Oral Dosing Trial." August 2025. https://www.prnewswire.com/news-releases/viking-therapeutics-announces-positive-top-line-results-from-phase-2-venture-oral-dosing-trial-302533355.html
  4. ClinicalTrials.gov. VANQUISH-1 Trial Registry (NCT06616870). https://clinicaltrials.gov/study/NCT06616870

Last updated October 6, 2026

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