Drugs / Tarpeyo
Regulatory milestones approvals, filings & regulatory actions · 2 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Label expansion | US (FDA) | TARPEYO | — | 2023-12-20 | fda.gov ↗ |
| Approved | US (FDA) | TARPEYO | — | 2021-12-15 | fda.gov ↗ |
Trials 1
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 1 | NCT06922305 | Dec 2023 → Jan 2024 | IgA glomerulonephritis, autoimmune hepatitis | Jiangsu HengRui Medicine Co., Ltd. | Completed | Met primary |
News releases announcing trial results or a regulatory action · 2
| Date | Issuer | Release |
|---|---|---|
| 2026-06-29 | Pfizer's Upjohn has merged with Mylan to form Viatris Inc. | Results Viatris Announces Positive Top-Line Results from Phase 3 Study of VR-205 in Japanese Adults with Primary Immunoglobulin A Nephropathy viatris.com ↗
The study achieved its primary endpoint, with VR-205 demonstrating a 33.75 percent reduction in geometric mean urine protein-to-creatinine ratio (UPCR) at 9 months compared to baseline [95% CI: -45.27 to -19.80; p < 0.001]. |
| 2025-11-04 | Zydus Lifesciences Limited | Regulatory Zydus receives tentative approval from USFDA for Budesonide delayed- release capsules, 4 mg zyduslife.com ↗
Zydus Lifesciences Limited (including its subsidiaries/ affiliates, hereafter referred to as “Zydus”) has received tentative approval from the United States Food and Drug Administration (USFDA) for Budesonide delayed-release capsules, 4 mg (USRLD: Tarpeyo Capsules, 4 mg). |
All press releases naming this drug 3 releases
| Date | Issuer | Release |
|---|---|---|
| 2026-06-29 | Pfizer's Upjohn has merged with Mylan to form Viatris Inc. | Viatris Announces Positive Top-Line Results from Phase 3 Study of VR-205 in Japanese Adults with Primary Immunoglobulin A Nephropathy viatris.com ↗ |
| 2025-11-04 | Zydus Lifesciences Limited | Zydus receives tentative approval from USFDA for Budesonide delayed- release capsules, 4 mg zyduslife.com ↗ |
| 2024-03-29 | Triastek (Shanghai) Limited | Triastek's 3D Printed Product for IgA Nephropathy, D23 (budesonide), Receives NMPA Clearance of IND Application triastek.com ↗ |
Evidence & citations 3 cited values
Every value below carries the sentence it was read from. 1 source stands behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Tarpeyo | ClinicalTrials.gov intervention name — accepted as the source's own label NCT06922305 ↗ |
| Known as | budesonide | “To evaluate the oral relative bioavailability of HR19042 Capsules compared with budesonide delayed-release capsules (Tarpeyo®) and budesonide enteric-coated capsules (Budenofalk®).” NCT06922305 ↗ |
| Route | Oral | “subjects received oral administration of either HR19042 Capsule 16 mg, Tarpeyo® 16 mg, or Budenofalk® 15 mg.” NCT06922305 ↗ |