Drugs / VK0214
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Clinical hold | US (FDA) | — | adrenoleukodystrophy | 2022-07-19 | “today announced that the FDA has lifted the clinical hold placed on the clinical trial of VK0214 in patients with X-linked adrenoleukodystrophy (X-ALD).” vikingtherapeutics.com ↗ |
Trials 1
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 1 | NCT04973657 | Jun 2021 → Oct 2024 | adrenomyeloneuropathy | Viking Therapeutics, Inc. | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 9
| Date | Issuer | Release |
|---|---|---|
| 2024-10-09 | Viking Therapeutics, Inc. | Results Viking Therapeutics Announces Results from Phase 1b Clinical Trial of VK0214 in Patients with X-ALD vikingtherapeutics.com ↗
Results from this study showed VK0214 to be safe and well-tolerated following once-daily dosing over the 28-day study period. |
| 2022-07-19 | Viking Therapeutics, Inc. | Regulatory Viking Therapeutics Announces FDA Has Lifted Clinical Hold on Phase 1b Trial of VK0214 in Patients with X-ALD vikingtherapeutics.com ↗ |
| 2022-01-24 | Viking Therapeutics, Inc. | Regulatory Viking Therapeutics Announces Clinical Hold on Phase 1b Trial of VK0214 in Patients with X-ALD vikingtherapeutics.com ↗
The FDA has requested an additional preclinical study prior to continuing the Phase 1b study of VK0214 in X-ALD. |
| 2021-06-17 | Viking Therapeutics, Inc. | Results Viking Therapeutics Announces Results from Phase 1 Clinical Trial of Novel Oral Thyroid Receptor Beta Agonist VK0214 vikingtherapeutics.com ↗
In this study, VK0214 demonstrated encouraging safety and tolerability, as well as a predictable pharmacokinetic (PK) profile. |
| 2017-10-23 | Viking Therapeutics, Inc. | Results Viking Therapeutics Presents Results from Proof-of-Concept Study of VK0214 in In Vivo Model of X-Linked Adrenoleukodystrophy (X-ALD) at the 87th Annual Meeting of the American Thyroid Association vikingtherapeutics.com ↗ |
| 2017-10-04 | Viking Therapeutics, Inc. | Results Viking Therapeutics Announces Top-Line Results from Proof-of-Concept Study of VK0214 in In Vivo Model of X-Linked Adrenoleukodystrophy (X-ALD) vikingtherapeutics.com ↗ |
| 2016-12-06 | Viking Therapeutics, Inc. | Regulatory Viking Therapeutics Receives Orphan Drug Designation for VK0214 from the U.S. Food and Drug Administration for the Treatment of X-Linked Adrenoleukodystrophy vikingtherapeutics.com ↗
Viking Therapeutics, Inc. ("Viking") (NASDAQ: VKTX), a clinical-stage biopharmaceutical company focused on the development of novel therapies for metabolic and endocrine disorders, today announced that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation to VK0214 for the treatment of X-linked adrenoleukodystrophy (X-ALD). |
| 2016-09-26 | Viking Therapeutics, Inc. | Results Viking Therapeutics Presents Positive Proof-of-Concept Data for VK0214 in In Vivo Model of X-Linked Adrenoleukodystrophy (X-ALD) at the 86th Annual Meeting of the American Thyroid Association vikingtherapeutics.com ↗
The study successfully achieved its primary objective, which was to demonstrate the ability of VK0214 to lower plasma very long chain fatty acid (VLCFA) levels after six weeks of treatment. |
| 2016-07-26 | Viking Therapeutics, Inc. | Results Viking Therapeutics Announces Positive Top-Line Results from Proof-of-Concept Study of VK0214 in In Vivo Model of X-Linked Adrenoleukodystrophy (X-ALD) vikingtherapeutics.com ↗
The results of this study showed that VK0214 rapidly reduced plasma very long chain fatty acid (VLCFA) levels by more than 25% in treated animals compared with vehicle controls (p < 0.01). |
All press releases naming this drug 11 releases
Evidence & citations 2 cited values
Every value below carries the sentence it was read from. 2 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | VK0214 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT04973657 ↗ |
| Modality | Small molecule | — CHEMBL4802139 ↗ |