Drugs / Tune-401
Trials 1
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 1 | NCT06671093 | Nov 2024 → Jun 2028 expected | chronic hepatitis B virus infection | Tune Therapeutics, Inc. | Recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 5
| Date | Issuer | Release |
|---|---|---|
| 2026-05-30 | Tune Therapeutics, Inc. | Results Tune Therapeutics Presents Positive Phase 1b/2a Proof of Concept Data on TUNE-401: a First-in-Class Epigenetic Silencer for Patients with Hepatitis B at EASL 2026 tunetx.com ↗
Initial clinical data shows deep and durable antiviral activity, including direct silencing of cccDNA, offering a possible pathway to a finite cure for HBV patients |
| 2025-01-07 | Tune Therapeutics, Inc. | Regulatory Tune Therapeutics Receives Approval to Initiate Clinical Trial in Hong Kong for HepB Epigenetic Silencer tunetx.com ↗
Tune Therapeutics announced today that it will begin a clinical trial in Hong Kong after receiving a Certificate for Clinical Trial from the Hong Kong Department of Health. |
| 2024-11-19 | Tune Therapeutics, Inc. | Results AASLD 2024: Tune Therapeutics Shows Near-Complete HepB Repression With Tune-401 Epigenetic Silencer tunetx.com ↗
Preclinical data shows strong, durable, and precise repression of HBV DNA across in vitro and in vivo models, offering a possible pathway to a functional cure |
| 2024-11-15 | Tune Therapeutics, Inc. | Regulatory Tune Therapeutics Moves into Clinical Spotlight with TUNE-401: A First-in-Class Epigenetic Silencer for Hepatitis B tunetx.com ↗
Tune Therapeutics announced today that it has received clinical trial application (CTA) approval from the New Zealand Medicines and Medical Devices Safety Authority (Medsafe) to initiate a Phase 1b clinical trial for TUNE-401 – an investigational epigenetic silencing therapy designed to treat chronic Hepatitis B (HBV). |
| 2023-12-06 | Tune Therapeutics, Inc. | Results Tune Therapeutics Presents First Data Supporting TUNE-401: a First-in-Class Epigenetic Silencer for Hepatitis B tunetx.com ↗
Data shows deep repression of HBV both in primary cells and ‘gold standard’ humanized mouse model |
All press releases naming this drug 5 releases
| Date | Issuer | Release |
|---|---|---|
| 2026-05-30 | Tune Therapeutics, Inc. | Tune Therapeutics Presents Positive Phase 1b/2a Proof of Concept Data on TUNE-401: a First-in-Class Epigenetic Silencer for Patients with Hepatitis B at EASL 2026 tunetx.com ↗ |
| 2025-01-07 | Tune Therapeutics, Inc. | Tune Therapeutics Receives Approval to Initiate Clinical Trial in Hong Kong for HepB Epigenetic Silencer tunetx.com ↗ |
| 2024-11-19 | Tune Therapeutics, Inc. | AASLD 2024: Tune Therapeutics Shows Near-Complete HepB Repression With Tune-401 Epigenetic Silencer tunetx.com ↗ |
| 2024-11-15 | Tune Therapeutics, Inc. | Tune Therapeutics Moves into Clinical Spotlight with TUNE-401: A First-in-Class Epigenetic Silencer for Hepatitis B tunetx.com ↗ |
| 2023-12-06 | Tune Therapeutics, Inc. | Tune Therapeutics Presents First Data Supporting TUNE-401: a First-in-Class Epigenetic Silencer for Hepatitis B tunetx.com ↗ |
Evidence & citations 2 cited values
Every value below carries the sentence it was read from. 1 source stands behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Tune-401 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT06671093 ↗ |
| Route | Intravenous | “for intravenous (IV) administration” NCT06671093 ↗ |