Drugs / RO7234292
Trials 4
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial | ||||||
| Phase 1 | NCT04000594 | Sep 2019 → Jan 2022 | Huntington disease | Hoffmann-La Roche | Completed | No outcome recorded |
| Phase 21 trial | ||||||
| Phase 2 | NCT03342053 | Jan 2018 → Oct 2019 | Huntington disease | Hoffmann-La Roche | Completed | No outcome recorded |
| Phase 32 trials | ||||||
| Phase 3 | NCT03842969 | Apr 2019 → Mar 2022 | Huntington disease | Hoffmann-La Roche | Completed | No outcome recorded |
| Phase 3 | NCT03761849 | Jan 2019 → Mar 2022 | Huntington disease | Hoffmann-La Roche | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 10
| Date | Issuer | Release |
|---|---|---|
| 2021-03-22 | Hoffmann-La Roche | Results Roche provides update on tominersen programme in manifest Huntington’s disease roche.com ↗
Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced the decision to discontinue dosing in the Phase III GENERATION HD1 study of tominersen in manifest Huntington’s disease (HD). |
| 2021-03-22 | Genentech, Inc. | Results Genentech Provides Update on Tominersen Program in Manifest Huntington’s Disease gene.com ↗ |
| 2021-03-22 | Ionis Pharmaceuticals | Results Ionis' partner provides update on clinical studies evaluating tominersen (IONIS-HTT Rx) ionis.com ↗
Ionis Pharmaceuticals, Inc. (NASDAQ: IONS) announced its partner, Roche, has decided to discontinue dosing in the Phase III GENERATION HD1 study of tominersen in manifest Huntington's disease (HD). |
| 2020-02-17 | Chugai Pharmaceutical | Regulatory Chugai Receives Orphan Drug Designation for RG6042 in Huntington's Disease from the MHLW chugai-pharm.co.jp ↗
Chugai Pharmaceutical Co., Ltd. (TOKYO: 4519) announced that the Ministry of Health, Labour and Welfare (MHLW) has designated the company’s investigational medicine RG6042 as an orphan drug for the expected treatment of Huntington's disease. |
| 2019-04-29 | Hoffmann-La Roche | Results New Roche data at the 2019 AAN Annual Meeting showcase breadth and promise of neuroscience portfolio roche.com ↗ |
| 2019-04-28 | Genentech, Inc. | Results New Genentech Data at the 2019 AAN Annual Meeting Showcase Breadth and Promise of Neuroscience Portfolio gene.com ↗
New data in Huntington’s disease support dose selection for Phase III trial and provide insight on mutant huntingtin protein (mHTT) reduction |
| 2018-08-03 | Hoffmann-La Roche | Regulatory PRIME designation granted by European Medicines Agency for RG6042 for treatment of Huntington's disease roche.com ↗
Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the European Medicines Agency (EMA) has granted PRIME (PRIority MEdicines) designation for the company's investigational medicine RG6042 (formerly known as IONIS-HTTRx) for the treatment of people with Huntington's disease (HD). |
| 2018-08-02 | Ionis Pharmaceuticals | Regulatory IONIS-HTT Rx (RG6042) Granted PRIME Designation by the European Medicines Agency for the Treatment of People with Huntington's Disease ionis.com ↗
Ionis Pharmaceuticals, Inc. (Nasdaq: IONS), the leader in antisense therapeutics, today announced that the European Medicines Agency (EMA) has granted Priority Medicines (PRIME) designation to IONIS-HTTRx (also known as RG6042) for the treatment of people with Huntington's disease (HD). |
| 2018-04-24 | Ionis Pharmaceuticals | Results New Data from IONIS-HTT Rx Phase 1/2 Study Demonstrates Correlation Between Reduction of Disease-causing Protein and Improvement in Clinical Measures of Huntington's Disease ionis.com ↗
Results from exploratory analyses of data from the study demonstrated correlations between reductions in mutant huntingtin (mHTT), the disease-causing protein, and improvements in clinical measures of Huntington's disease. |
| 2018-03-01 | Ionis Pharmaceuticals | Results IONIS-HTT Rx (RG6042) Top-Line Data Demonstrate Significant Reductions of Disease-Causing Mutant Huntingtin Protein in People with Huntington's Disease ionis.com ↗
The data demonstrate that IONIS-HTTRx (RG6042) is the first drug in development to lower the disease-causing protein in people with HD. |
All press releases naming this drug 11 releases
Evidence & citations 4 cited values
Every value below carries the sentence it was read from. 4 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | RO7234292 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT03761849 ↗ |
| Known as | ISIS 443139 | “RO7234292 (ISIS 443139)” NCT03342053 ↗ |
| Known as | RG6042 | “A Study to Evaluate the Efficacy and Safety of Intrathecally Administered RO7234292 (RG6042) in Participants With Manifest Huntington's Disease” NCT03761849 ↗3“RO7234292 (RG6042)” NCT04000594 ↗ “RO7234292 (RG6042)” NCT03842969 ↗ “RO7234292 (RG6042)” NCT03342053 ↗ |
| Route | Intrathecal | “Intrathecal injection” NCT03761849 ↗ |