This section highlights FDA-related milestones and regulatory updates for drugs developed by Ventyx Biosciences (VTYX).
Over the past two years, Ventyx Biosciences has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
VTX2735, VTX3232, and VTX958. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
VTX2735 - FDA Regulatory Timeline and Events
VTX2735 is a drug developed by Ventyx Biosciences for the following indication: For Parkinson's disease.
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:
- VTX2735
- Announced Date:
- January 14, 2025
- Estimated Event Date Range:
- July 1, 2025 - December 31, 2025
- Target Action Date:
- H2 2025
- Indication:
- For Parkinson's disease
Announcement
Ventyx Biosciences, Inc. announced that Phase 2 trial of VTX2735 in participants with recurrent pericarditis expected to initiate in January, with topline data expected in H2 2025
AI Summary
Ventyx Biosciences, Inc. announced that it will start a Phase 2 trial of its peripherally restricted NLRP3 inhibitor VTX2735 for patients with recurrent pericarditis in January 2025. The trial is open-label and plans to enroll about 30 participants who will undergo a 6-week primary treatment followed by a 7-week extension phase. Key study endpoints include safety, changes in pain scores measured on the Numeric Rating Scale (NRS), and levels of high sensitivity C-reactive protein (hsCRP). Recurrent pericarditis is linked to an over-activation of the body’s inflammatory response, particularly involving the NLRP3 inflammasome and IL-1. Topline data from this trial are expected to be available in the second half of 2025, and the company believes that VTX2735 may offer a safer, effective, and convenient oral treatment option for patients with this challenging condition.
Read Announcement
VTX3232 - FDA Regulatory Timeline and Events
VTX3232 is a drug developed by Ventyx Biosciences for the following indication: In patients with early Parkinson's disease.
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:
- VTX3232
- Announced Date:
- June 17, 2025
- Indication:
- In patients with early Parkinson's disease.
Announcement
Ventyx Biosciences, Inc. announced positive top-line results from its Phase 2a study of VTX3232, a novel, CNS-penetrant NLRP3 inhibitor, in patients with early-stage Parkinson's disease (NCT06556173).
AI Summary
Ventyx Biosciences announced positive top-line results from its Phase 2a study evaluating VTX3232, a novel, CNS-penetrant NLRP3 inhibitor, in patients with early-stage Parkinson’s disease (NCT06556173). The study successfully met its primary objective by demonstrating that VTX3232 is safe and well tolerated, with no drug-related treatment-emergent adverse events observed during the 28-day dosing period. A once-daily 40mg dose maintained plasma and cerebrospinal fluid (CSF) levels above the therapeutic threshold for 24 hours, confirming a favorable pharmacokinetic profile.
Furthermore, significant reductions in NLRP3-related biomarkers in both plasma and CSF indicated strong target engagement. These promising findings support the potential of VTX3232 as a disease-modifying therapy for neurodegenerative conditions such as Parkinson’s disease. Based on these encouraging results, the company is planning further placebo-controlled Phase 2 trials to validate the efficacy and long-term benefits of the treatment.
Read Announcement- Drug:
- VTX3232
- Announced Date:
- January 14, 2025
- Estimated Event Date Range:
- January 1, 2025 - June 30, 2025
- Target Action Date:
- H1 2025
- Indication:
- In patients with early Parkinson's disease.
Announcement
Ventyx Biosciences, Inc. Topline data from ongoing Phase 2 biomarker trial of VTX3232 in participants with early Parkinson's disease expected in H1 2025
AI Summary
Ventyx Biosciences, Inc. is progressing with its development of innovative oral therapies for neurodegenerative diseases. The company's ongoing Phase 2 biomarker trial of its CNS-penetrant NLRP3 inhibitor, VTX3232, in participants with early Parkinson’s disease is of particular importance. This trial, which is enrolling around 10 subjects, aims to evaluate safety, pharmacokinetics, and key biomarkers in both cerebrospinal fluid and plasma. Additionally, the trial includes exploratory TSPO PET imaging to assess microglial activation. Topline data from this study is expected in the first half of 2025. These results are anticipated to provide valuable evidence in support of VTX3232's ability to modulate neuroinflammation, potentially offering a new therapeutic approach for patients with early Parkinson’s disease.
Read Announcement- Drug:
- VTX3232
- Announced Date:
- January 14, 2025
- Estimated Event Date Range:
- July 1, 2025 - December 31, 2025
- Target Action Date:
- H2 2025
- Indication:
- In patients with early Parkinson's disease.
Announcement
Ventyx Biosciences, Inc. announced that First subjects dosed in a Phase 2 trial of VTX3232 in participants with obesity and cardiometabolic risk factors, with topline data expected in H2 2025
AI Summary
Ventyx Biosciences has taken a significant step forward by dosing the first subjects in a Phase 2 trial of its CNS-penetrant NLRP3 inhibitor VTX3232. The trial targets participants with obesity and cardiometabolic risk factors, enrolling about 160 subjects who will receive either VTX3232 alone, in combination with semaglutide, or a placebo. The study aims to evaluate the treatment’s safety and its effect on key markers such as high sensitivity C-reactive protein (hsCRP), with topline data expected in the second half of 2025.
This trial is part of Ventyx’s broader 2025 clinical program focused on innovative oral therapies for diseases driven by inflammation. With additional trials underway for conditions like recurrent pericarditis and early Parkinson’s disease, the company is positioning itself as a leader in addressing both neurological and cardiometabolic diseases through NLRP3 inhibition.
Read Announcement- Drug:
- VTX3232
- Announced Date:
- January 14, 2025
- Indication:
- In patients with early Parkinson's disease.
Announcement
Ventyx Biosciences, Inc. today highlighted its 2025 pipeline strategy and provided clinical updates on its NLRP3 inhibitor portfolio, including VTX2735 and VTX3232.
AI Summary
Ventyx Biosciences announced its 2025 pipeline strategy, focusing on advancing its NLRP3 inhibitor portfolio. The company is progressing two main candidates: VTX2735, a peripherally restricted NLRP3 inhibitor, and VTX3232, a CNS-penetrant inhibitor. VTX2735 is set to begin a Phase 2 trial in patients with recurrent pericarditis in January, with topline data anticipated in the second half of 2025. Meanwhile, VTX3232 is being tested in two settings. One trial involves patients with obesity and cardiometabolic risk factors, with results expected in the second half of 2025. Another ongoing Phase 2 trial is evaluating VTX3232 in early Parkinson’s disease, with topline data projected for the first half of 2025. These studies are aimed at establishing Ventyx as a leader in targeting the NLRP3 inflammasome, which may offer new treatment options for systemic and neurological diseases.
Read Announcement- Drug:
- VTX3232
- Announced Date:
- September 6, 2024
- Indication:
- In patients with early Parkinson's disease.
Announcement
Ventyx Biosciences, Inc announced that the first patient has been dosed in a Phase 2a trial of VTX3232 in patients with early Parkinson's disease.
AI Summary
Ventyx Biosciences, Inc. announced that the first patient has been dosed in their Phase 2a trial of VTX3232 for early Parkinson’s disease. This trial, which will enroll about ten patients for a 28-day open-label treatment period, is primarily focused on assessing the safety and tolerability of the drug. Researchers will also evaluate pharmacokinetics and explore disease-relevant biomarkers in both plasma and cerebrospinal fluid. In addition, the study will use PET neuroimaging to measure microglial activation, aiming to understand whether VTX3232 can disrupt the progression of Parkinson’s disease by targeting NLRP3-driven neuroinflammation. The insights gained from this trial are expected to provide valuable information on the drug’s potential impact on Parkinson’s pathology, with topline results anticipated to be reported in 2025.
Read Announcement
VTX958 - FDA Regulatory Timeline and Events
VTX958 is a drug developed by Ventyx Biosciences for the following indication: Psoriasis, psoriatic arthritis, Crohn's disease, ulcerative colitis and lupus.
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:
- VTX958
- Announced Date:
- July 29, 2024
- Indication:
- Psoriasis, psoriatic arthritis, Crohn's disease, ulcerative colitis and lupus
Announcement
Ventyx Biosciences, Inc. announced results from the Phase 2 trial of its allosteric TYK2 inhibitor VTX958 in participants with moderately to severely active Crohn's disease.
AI Summary
Ventyx Biosciences recently announced the results of its Phase 2 trial for VTX958, an allosteric TYK2 inhibitor, in patients with moderately to severely active Crohn’s disease. The trial included 109 participants who received either 225 mg, 300 mg twice daily, or a placebo over 12 weeks. While the study did not meet its primary endpoint of improving the Crohn’s Disease Activity Index (CDAI) score, both doses showed a dose-dependent improvement on the key secondary endpoint of endoscopic response, measured by a 50% reduction in the SES-CD score.
Additionally, VTX958 demonstrated greater reductions in inflammatory biomarkers such as C-reactive protein and fecal calprotectin and was well tolerated by patients. Based on these findings, Ventyx plans further data analysis to understand the differences between symptomatic and endoscopic responses and currently does not plan additional clinical trials with internal resources.
Read Announcement- Drug:
- VTX958
- Announced Date:
- July 29, 2024
- Indication:
- Psoriasis, psoriatic arthritis, Crohn's disease, ulcerative colitis and lupus
Announcement
Ventyx Biosciences, Inc. announced results from the Phase 2 trial of its allosteric TYK2 inhibitor VTX958 in participants with moderately to severely active Crohn's disease.
AI Summary
Ventyx Biosciences announced the Phase 2 trial results for its allosteric TYK2 inhibitor VTX958, tested in participants with moderately to severely active Crohn’s disease. In the study, 109 patients received either 225 mg or 300 mg of VTX958 twice daily, or a placebo over a 12-week period. Although the trial did not meet its primary endpoint—the change from baseline in the Crohn’s Disease Activity Index (CDAI) score—both VTX958 dose groups achieved significant results on the key secondary endpoint of endoscopic response, as measured by a 50% reduction in the SES-CD score.
The results also showed a dose-dependent improvement in key biomarkers of inflammation, including C-reactive protein and fecal calprotectin. VTX958 was well tolerated during the trial. Based on these findings, Ventyx plans to further analyze the data and does not anticipate additional clinical trials for VTX958 using internal resources.
Read Announcement
