Drugs / PVT201
last change Nov 2025 re-read 3 minutes ago

PVT201

Developed for
primary biliary cholangitis
Investigated by
Avance Clinical Pty Ltd. · Parvus Therapeutics, Inc.

Trials 1

20252026
PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 1 NCT06798454 Oct 2024 → Apr 2025 primary biliary cholangitis Parvus Therapeutics, Inc. Completed No outcome recorded

News releases announcing trial results or a regulatory action · 2

DateIssuerRelease
2025-11-12 Parvus Therapeutics, Inc. Results Parvus Therapeutics Reports Positive Phase 1 Results for Lead Autoimmune Treg Therapy, PVT201 parvustx.com ↗
PVT201 was safe and well tolerated across all dose levels, with no serious adverse events and no clinically meaningful changes in vital signs, ECGs, or laboratory parameters.
2024-07-29 Parvus Therapeutics, Inc. Regulatory Parvus Therapeutics announces that PVT201 has received Orphan Drug Designation parvustx.com ↗
Parvus Therapeutics announced today that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation to PVT201 for the treatment of Primary Biliary Cholangitis (PBC) and PVT201 has obtained Australian Human Research Ethics Committee (HREC) approval to initiate a first-in-human Phase I clinical trial.

Evidence & citations 2 cited values

Every value below carries the sentence it was read from. 1 source stands behind the page.

FieldValueCited text
Known as PVT201 ClinicalTrials.gov intervention name — accepted as the source's own label NCT06798454 ↗
Route Intravenous “PVT201 will be administered intravenously.” NCT06798454 ↗