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
VK0214, VK2735, and VK2809. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
VK0214 - FDA Regulatory Timeline and 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.
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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:
- 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
- Estimated Event Date Range:
- July 1, 2025 - December 31, 2025
- Target Action Date:
- H2 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.
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VK2809 - FDA Regulatory Timeline and 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.
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