This section highlights FDA-related milestones and regulatory updates for drugs developed by Viking Therapeutics (VKTX).
Over the past two years, Viking Therapeutics has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
VK2735, VK2809, and VK0214. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
Select a button below to view the list of FDA events for that drug.
VK2735 FDA Regulatory Timeline and Events
VK2735 is a drug developed by Viking Therapeutics for the following indication: Metabolic disorders.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- VK2735
- Announced Date:
- March 26, 2026
- Indication:
- Metabolic disorders
Announcement
Viking Therapeutics, Inc announced the completion of patient enrollment in its Phase 3 VANQUISH-2 clinical trial of subcutaneous VK2735, the company's dual agonist of the glucagon-like peptide 1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP) receptors.
AI Summary
Viking Therapeutics announced it has completed patient enrollment in its Phase 3 VANQUISH-2 trial of subcutaneous VK2735, a dual agonist that targets the GLP-1 and GIP receptors. The trial is a 78-week study enrolling adults with obesity and type 2 diabetes. Finishing enrollment is an important milestone that lets the company move fully into the treatment and follow-up phases of the study.
VK2735 is designed to engage both GLP-1 and GIP pathways, which may help improve blood sugar control and reduce body weight. With enrollment closed, Viking will continue dosing participants, monitor safety and gather efficacy data over the 78 weeks, and work toward reporting topline results per its trial timeline. The company views this step as key to evaluating VK2735’s potential as a new therapy for people with obesity and type 2 diabetes.
Read Announcement- Drug:
- VK2735
- Announced Date:
- January 12, 2026
- Indication:
- Metabolic disorders
Announcement
Viking Therapeutics, Inc announced the publication of the results of the company's Phase 2 VENTURE clinical trial of VK2735, a dual agonist of the glucagon-like peptide 1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP) receptors. VK2375 is being developed in both oral and subcutaneous formulations for the potential treatment of various metabolic disorders such as obesity.
AI Summary
Viking Therapeutics published Phase 2 VENTURE results for VK2735, a dual GLP‑1/GIP receptor agonist being developed in oral and weekly subcutaneous forms for obesity and other metabolic disorders. The peer‑reviewed paper in Obesity reports that after 13 weekly subcutaneous doses patients lost up to 14.7% of baseline body weight with no clear plateau. The trial met its primary and secondary endpoints, and most adverse events were mild or moderate; treatment and study discontinuation rates were similar to placebo.
Viking is advancing subcutaneous VK2735 in a Phase 3 VANQUISH program with two randomized, double‑blind, placebo‑controlled trials dosed weekly for 78 weeks. VANQUISH‑1 (about 4,650 adults) and VANQUISH‑2 (about 1,100 adults with type 2 diabetes) randomize participants to 7.5 mg, 12.5 mg, 17.5 mg or placebo. The company also completed enrollment in an exploratory Phase 1 maintenance dosing study (about 180 adults) to evaluate dosing after initial weight loss.
Read Announcement- Drug:
- VK2735
- Announced Date:
- January 8, 2026
- Indication:
- Metabolic disorders
Announcement
Viking Therapeutics, Inc. announced the completion of patient enrollment in its exploratory maintenance dosing study of VK2735, the company's dual agonist of the glucagon-like peptide 1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP) receptors.
AI Summary
Viking Therapeutics announced completion of enrollment in a Phase 1 exploratory maintenance dosing study of VK2735, its dual GLP-1/GIP agonist being developed for obesity in both oral and subcutaneous forms. The randomized, double-blind, placebo-controlled trial enrolled about 180 otherwise healthy adults with BMI ≥30 kg/m2. All participants received weekly subcutaneous VK2735 or placebo for the first 19 weeks to induce initial weight loss. After Week 19 they were switched to maintenance regimens: weekly, every-other-week, or monthly subcutaneous dosing, or daily or weekly oral dosing, or placebo.
The study’s main goals are to evaluate safety, tolerability, and pharmacokinetics across these regimens. Exploratory endpoints include change in body weight from baseline and change from Week 19 to Week 31. Viking said using the same active molecule in both oral and injectable forms may offer treatment flexibility, potentially improving adherence, and plans to report results later this year.
Read Announcement- Drug:
- VK2735
- Announced Date:
- November 19, 2025
- Indication:
- Metabolic disorders
Announcement
Viking Therapeutics, Inc announced the completion of patient enrollment in its Phase 3 VANQUISH-1 clinical trial of subcutaneous VK2735, the company's dual agonist of the glucagon-like peptide 1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP) receptors.
AI Summary
Viking Therapeutics announced it has completed patient enrollment in the Phase 3 VANQUISH-1 trial of subcutaneous VK2735 ahead of schedule and above target. The study enrolled about 4,650 adults with obesity (BMI ≥30 kg/m2) or who are overweight (BMI ≥27 kg/m2) with at least one weight-related condition.
VANQUISH-1 is a randomized, double-blind, placebo-controlled, multicenter trial testing once-weekly subcutaneous VK2735 for 78 weeks. Participants were randomized to VK2735 7.5 mg, 12.5 mg, 17.5 mg or placebo. The primary endpoint is percent change in body weight at 78 weeks versus placebo, with secondary measures including the share of participants achieving ≥5%, ≥10%, ≥15% and ≥20% weight loss. The study also includes a 52-week extension for continued treatment.
VK2735 is a dual GLP-1/GIP receptor agonist being developed in both subcutaneous and oral forms for metabolic disorders. Viking said the fast, above-target enrollment reflects strong interest in new obesity treatments.
Read Announcement- Drug:
- VK2735
- Announced Date:
- November 6, 2025
- Indication:
- Metabolic disorders
Announcement
Viking Therapeutics, Inc. announced that new clinical data from the company's VK2735 obesity program were highlighted in a poster presentation at ObesityWeek® 2025, the annual meeting of The Obesity Society.
AI Summary
At ObesityWeek® 2025, Viking Therapeutics presented new clinical data from its VK2735 obesity program. VK2735 is a dual GLP-1/GIP receptor agonist being evaluated in subcutaneous and oral forms for obesity and metabolic disorders.
In a Phase 2 VENTURE trial, patients received weekly subcutaneous VK2735 injections for 13 weeks. By Week 13, 78% of prediabetic participants reached normal blood sugar, versus 29% on placebo (p=0.0008).
The study also found 68% of patients with metabolic syndrome no longer met syndrome criteria at Week 13, versus 38% on placebo (p=0.02). These gains reflect better waist measurements, blood pressure, lipids, and glucose control.
These results suggest VK2735 may help prevent type 2 diabetes and reduce cardiovascular risk. Viking is now testing subcutaneous and oral VK2735 in Phase 3 obesity trials to confirm these effects.
Read Announcement- Drug:
- VK2735
- Announced Date:
- October 29, 2025
- Indication:
- Metabolic disorders
Announcement
Viking Therapeutics, Inc. announced that the company's VK2735 obesity program will be the focus of two poster presentations at ObesityWeek® 2025, the annual meeting of The Obesity Society.
AI Summary
Viking Therapeutics, Inc. announced that its obesity program, VK2735, will be featured in two poster presentations at ObesityWeek® 2025, the annual meeting of The Obesity Society, held November 4–7 in Atlanta, Georgia. VK2735 is a novel dual agonist targeting the GLP-1 and GIP receptors, designed to help treat metabolic disorders. Viking is testing both subcutaneous and oral formulations in clinical trials.
The first poster will present exploratory results from the Phase 2 VENTURE study, which examined 13 weeks of weekly subcutaneous VK2735 treatment in obese participants. This analysis focuses on how VK2735 affected the prevalence of prediabetes and metabolic syndrome over the study period.
The second poster will describe the design of the ongoing Phase 3 VANQUISH-1 trial. That study is evaluating subcutaneous VK2735 in adults with obesity or overweight individuals who have at least one weight-related co-morbid condition.
Read Announcement- Drug:
- VK2735
- Announced Date:
- October 21, 2025
- Indication:
- Metabolic disorders
Announcement
Viking Therapeutics, Inc announced the initiation of an exploratory maintenance dosing study of VK2735, the company's dual agonist of the glucagon-like peptide 1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP) receptors.
AI Summary
Viking Therapeutics has started an exploratory Phase 1 trial to test maintenance dosing of VK2735, its dual agonist of the GLP-1 and GIP receptors, in adults with obesity. After 19 weeks of once-weekly subcutaneous VK2735 or placebo, about 180 participants will switch to one of four maintenance regimens: monthly subcutaneous injections, weekly oral tablets, daily oral tablets, or placebo.
The randomized, double-blind, placebo-controlled study will explore each regimen’s safety, tolerability, and pharmacokinetic profile. Investigators will also measure changes in body weight from the start of the trial and from Week 19 through Week 31.
“Flexible dosing options—including potential weekly or monthly injections and daily or weekly oral dosing—could help patients stick with therapy,” said Viking CEO Brian Lian. Better adherence may boost long-term weight loss benefits like lower cardiovascular risk and improved quality of life.
Viking expects to share study results in 2026.
Read Announcement- Drug:
- VK2735
- Announced Date:
- August 19, 2025
- Indication:
- Metabolic disorders
Announcement
Viking Therapeutics, Inc. announced positive top-line results from the company's Phase 2 clinical trial of the oral tablet formulation of VK2735, the company's dual agonist of the glucagon-like peptide 1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP) receptors.
Read Announcement- Drug:
- VK2735
- Announced Date:
- June 25, 2025
- Indication:
- Metabolic disorders
Announcement
Viking Therapeutics, Inc. announced the initiation of the VANQUISH Phase 3 clinical program for VK2735, the company's dual agonist of the glucagon-like peptide 1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP) receptors.
AI Summary
Viking Therapeutics, Inc. has initiated the VANQUISH Phase 3 clinical program for VK2735, its dual agonist targeting both the glucagon-like peptide 1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP) receptors. This study is designed to evaluate the safety and effectiveness of VK2735 in obese adults, including those with type 2 diabetes. The program includes two randomized, double-blind, placebo-controlled trials with participants receiving a once-weekly subcutaneous injection for 78 weeks. One study will enroll about 4,500 obese or overweight adults with at least one weight-related condition, while the other will include approximately 1,100 overweight or obese adults with type 2 diabetes. Researchers will assess body weight changes as the primary endpoint, along with other measures to monitor safety and efficacy. This advancement marks an important step in developing potential therapies that could significantly improve treatment outcomes for patients with metabolic disorders.
Read Announcement- Drug:
- VK2735
- Announced Date:
- March 26, 2025
- Target Action Date:
- H2 2025
- Estimated Target Date Range:
- July 1, 2025 - December 31, 2025
- Indication:
- Metabolic disorders
Announcement
Viking Therapeutics, Inc announced that Results Expected in 2H25
AI Summary
Viking Therapeutics, Inc. has completed enrollment for its Phase 2 clinical trial testing the safety and weight loss effectiveness of VK2735, an oral dual agonist targeting both the GLP-1 and GIP receptors. This study involves approximately 280 overweight and obese adults and is designed to last 13 weeks with once-daily dosing. The trial focuses on measuring the percentage change in body weight from the beginning of the study, along with additional safety and efficacy outcomes. The study’s design is randomized, double-blind, and placebo-controlled, ensuring strong data integrity. Viking Therapeutics announced that the results from this trial are expected in the second half of 2025. The company’s progress emphasizes growing enthusiasm for developing new therapeutic options for metabolic disorders, particularly obesity, while continuing its commitment to innovative clinical research in this field.
Read Announcement- Drug:
- VK2735
- Announced Date:
- March 26, 2025
- Indication:
- Metabolic disorders
Announcement
Viking Therapeutics, Inc announced the completion of subject enrollment in its Phase 2 clinical trial of the oral tablet formulation of VK2735, the company's dual agonist of the glucagon-like peptide 1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP) receptors.
AI Summary
Viking Therapeutics, Inc. announced that it has completed subject enrollment for its Phase 2 clinical trial of the oral tablet formulation of VK2735. This drug is a dual agonist that works on both the GLP-1 and GIP receptors and is aimed at treating metabolic disorders such as obesity. The randomized, double-blind, placebo-controlled study will evaluate the safety, tolerability, pharmacokinetics, and weight loss efficacy of VK2735 when taken once daily over 13 weeks. Approximately 280 adults with obesity or who are overweight with related health conditions participated in the trial. The study’s main goal is to measure the percent change in body weight from baseline, and Viking expects to share results in the second half of 2025. This enrollment milestone highlights strong interest in developing new oral treatment options for weight management.
Read Announcement- Drug:
- VK2735
- Announced Date:
- February 5, 2025
- Indication:
- Metabolic disorders
Announcement
Viking Therapeutics, Inc. provided clinical Updates
AI Summary
Viking Therapeutics, Inc. recently provided an update on its clinical efforts for the obesity treatment VK2735. The company saw positive results in its Phase 2 VENTURE study, where patients experienced significant and sustained weight loss – with reductions up to 14.7% in body weight – and the safety profile was encouraging, with most side effects being mild or moderate. Following a successful End-of-Phase 2 meeting with the FDA, Viking is planning to initiate Phase 3 trials for the subcutaneous formulation of VK2735 in the second quarter of 2025.
In addition, Viking is running a Phase 2 oral dosing trial for VK2735, which aims to provide an attractive non-injectable option for patients. This clinical update demonstrates the company’s commitment to advancing innovative treatments for obesity and metabolic disorders.
Read Announcement- Drug:
- VK2735
- Announced Date:
- January 8, 2025
- Indication:
- Metabolic disorders
Announcement
Viking Therapeutics, Inc announced the initiation of a Phase 2 clinical trial of the oral tablet formulation of VK2735, the company's dual agonist of the glucagon-like peptide 1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP) receptors.
AI Summary
Viking Therapeutics, Inc. has announced the start of a Phase 2 clinical trial to evaluate the oral tablet formulation of VK2735. This new formulation is a dual agonist that targets both the glucagon-like peptide 1 (GLP-1) and the glucose-dependent insulinotropic polypeptide (GIP) receptors. The trial, which will run for 13 weeks, is a randomized, double-blind, placebo-controlled, multicenter study designed to assess the safety, tolerability, pharmacokinetics, and weight loss efficacy among patients.
The study will enroll approximately 280 adults who are obese or overweight with a weight-related condition. Participants will receive once-daily doses of VK2735, and the primary goal of the trial is to measure the percent change in body weight from the baseline. This effort builds on encouraging early data and offers the potential for a well-tolerated, flexible treatment option for weight management.
Read Announcement
VK2809 FDA Regulatory Events
VK2809 is a drug developed by Viking Therapeutics for the following indication: In Biopsy-Confirmed NASH/MASH.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- VK2809
- Announced Date:
- November 19, 2024
- Indication:
- In Biopsy-Confirmed NASH/MASH
Announcement
Viking Therapeutics, Inc announced that final results from the company's Phase 2b clinical trial of VK2809, the company's novel liver-selective thyroid hormone receptor beta agonist, in patients with biopsy-confirmed non-alcoholic steatohepatitis (NASH; also referred to as metabolic dysfunction associated steatohepatitis, MASH) were highlighted in an oral late breaker presentation at the 75th Liver Meeting® 2024, the annual meeting of the American Association for the Study of Liver Disease (AASLD).
AI Summary
Viking Therapeutics, Inc. announced final results from its Phase 2b clinical trial of VK2809, a novel liver-selective thyroid hormone receptor beta agonist, in patients with biopsy-confirmed non-alcoholic steatohepatitis (NASH/MASH). These results were presented as an oral late breaker at the 75th Liver Meeting® 2024, hosted by the American Association for the Study of Liver Disease (AASLD).
The data from the VOYAGE study demonstrated that VK2809 successfully met both the primary and secondary endpoints. Patients experienced significant reductions in liver fat content at 12 and 52 weeks, along with notable NASH resolution and fibrosis improvement compared to placebo. In addition, the study highlighted promising improvements in plasma lipids and affirmed the drug’s excellent tolerability and safety profile throughout the treatment period.
Read Announcement
VK0214 FDA Regulatory Events
VK0214 is a drug developed by Viking Therapeutics for the following indication: X-linked adrenoleukodystrophy (X-ALD).
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- VK0214
- Announced Date:
- October 9, 2024
- Indication:
- X-linked adrenoleukodystrophy (X-ALD)
Announcement
Viking Therapeutics, Inc. announced positive data from the company's Phase 1b clinical trial of VK0214, a novel small molecule agonist of the thyroid hormone receptor beta (TRβ), in patients with X-linked adrenoleukodystrophy (X-ALD).
AI Summary
Viking Therapeutics, Inc. announced positive findings from its Phase 1b clinical trial of VK0214. VK0214 is a new, small molecule drug that activates the thyroid hormone receptor beta (TRβ) and is being tested in patients with X-linked adrenoleukodystrophy (X-ALD). In this trial, patients received once-daily doses of VK0214 for 28 days. The study showed that the drug was safe and well-tolerated, with no serious concerns reported. Importantly, the treatment led to significant reductions in plasma levels of very long-chain fatty acids (VLCFAs), which are key biomarkers of X-ALD. Reductions were also observed in a marker called C26:0-LPC, as well as improvements in other lipid levels such as LDL cholesterol. These encouraging results indicate that VK0214 may offer a promising new treatment option for patients suffering from X-ALD.
Read Announcement
Free VKTX Stock Alerts