Drugs / Revusiran
Trials 2
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 22 trials | ||||||
| Phase 2 | NCT02595983 | Oct 2015 → Feb 2017 | familial amyloid neuropathy | Alnylam Pharmaceuticals | Completed | No outcome recorded |
| Phase 2 | NCT02292186 | Oct 2014 → Feb 2017 | — | Alnylam Pharmaceuticals | Completed | No outcome recorded |
| Comparator or background therapy1 trial | ||||||
| Phase 3 | NCT02319005 Comparator | Dec 2014 → Mar 2017 | familial amyloid neuropathy | Alnylam Pharmaceuticals | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 15
| Date | Issuer | Release |
|---|---|---|
| 2016-10-05 | Alnylam Pharmaceuticals | Results Alnylam Pharmaceuticals Discontinues Revusiran Development alnylam.com ↗
The Company subsequently reviewed unblinded ENDEAVOUR data which revealed an imbalance of mortality in the revusiran arm as compared to placebo. |
| 2016-07-01 | Alnylam Pharmaceuticals | Results Alnylam Reports New Results from Investigational RNAi Therapeutic Programs for Hereditary Transthyretin-Mediated Amyloidosis with Polyneuropathy (hATTR-PN) and Cardiomyopathy (hATTR-CM) alnylam.com ↗
At 12 Months, Revusiran Achieves Generally Stable 6-Minute Walk Distance Results in Majority of Evaluable Patients with hATTR-CM |
| 2016-06-27 | Alnylam Pharmaceuticals | Results Alnylam to Report New Patisiran and Revusiran Results at the XV International Symposium on Amyloidosis alnylam.com ↗
All posters by Alnylam scientists and collaborators will be presented during the poster session on July 4, 2016 . |
| 2015-11-03 | Alnylam Pharmaceuticals | Results Alnylam Reports Positive Results from Ongoing Phase 2 Open-Label Extension (OLE) Studies for Patisiran and Revusiran, in Development for the Treatment of Transthyretin (TTR)-Mediated Amyloidosis (ATTR Amyloidosis) alnylam.com ↗
Revusiran Demonstrates Robust and Sustained Knockdown of Serum TTR of up to 98%, Representing Longest Human Target Gene Knockdown Experience with a GalNAc-siRNA Conjugate, and is Generally Well Tolerated in Majority of Patients with ATTR Cardiac Amyloidosis out to 10 Months of Treatment |
| 2015-05-20 | Alnylam Pharmaceuticals | Regulatory Alnylam Receives Orphan Drug Designation from the United States Food & Drug Administration for Revusiran, an Investigational RNAi Therapeutic for the Treatment of Transthyretin (TTR)-Mediated Amyloidosis (ATTR Amyloidosis) alnylam.com ↗
Alnylam Pharmaceuticals, Inc . (Nasdaq:ALNY), a leading RNAi therapeutics company, announced today that the United States Food & Drug Administration (FDA) has granted Orphan Drug Designation to revusiran, an investigational RNAi therapeutic, for the treatment of transthyretin (TTR)-mediated amyloidosis (ATTR amyloidosis). |
| 2015-03-15 | Alnylam Pharmaceuticals | Results Alnylam Presents Results from Natural History Study of Patients with Familial Amyloidotic Cardiomyopathy (FAC) and Presents Complete Results from Phase 2 Clinical Trial for Revusiran, an Investigational RNAi Therapeutic for the Treatment of FAC alnylam.com ↗
Consistent with preliminary results presented last year, revusiran achieved an up to 98.2% knockdown of serum TTR - the disease-causing protein - and was found to be generally well tolerated in the Phase 2 trial in FAC patients. |
| 2014-11-14 | Alnylam Pharmaceuticals | Results Alnylam Announces Positive Initial Phase 2 Data with Revusiran (ALN-TTRsc), an Investigational RNAi Therapeutic Targeting Transthyretin (TTR) for the Treatment of TTR Cardiac Amyloidosis, with up to 98.2% Knockdown of Serum TTR in Patients alnylam.com ↗
Revusiran demonstrated clinical activity with an up to 98.2% knockdown of serum TTR - the disease causing protein. |
| 2014-10-14 | Alnylam Pharmaceuticals | Results Alnylam Presents New Clinical and Pre-Clinical Data on RNAi Therapeutics at 10th Oligonucleotide Therapeutics Society (OTS) Meeting alnylam.com ↗
Additional Phase 1 Clinical Results with ALN-TTRsc and Results from Pre-Clinical Chronic Toxicology Studies Confirm Clinical Activity and Wide Therapeutic Index |
| 2014-04-29 | Alnylam Pharmaceuticals | Results Alnylam Presents New Pre-clinical Data on RNAi Therapeutics Targeting Transthyretin (TTR) for the Treatment of TTR-Mediated Amyloidosis (ATTR) alnylam.com ↗
Alnylam Pharmaceuticals, Inc . (Nasdaq: ALNY), a leading RNAi therapeutics company, announced today the presentation of new pre-clinical data on RNAi therapeutics targeting transthyretin (TTR) for the treatment of TTR-mediated amyloidosis (ATTR). |
| 2014-04-02 | Alnylam Pharmaceuticals | Regulatory Alnylam Receives Positive Opinion for Orphan Drug Designation in the European Union for ALN-TTRsc, a Subcutaneously Delivered RNAi Therapeutic for the Treatment of Transthyretin-Mediated Amyloidosis (ATTR) alnylam.com ↗
Alnylam Pharmaceuticals, Inc. (Nasdaq:ALNY), a leading RNAi therapeutics company, announced today that the European Medicines Agency (EMA) Committee for Orphan Medicinal Products (COMP) has adopted a positive opinion recommending ALN-TTRsc for designation as an orphan medicinal product for the treatment of transthyretin (TTR)-mediated amyloidosis (ATTR). |
| 2013-11-06 | Alnylam Pharmaceuticals | Results Alnylam Pharmaceuticals Reports Third Quarter 2013 Financial Results alnylam.com ↗
In this study, we demonstrated knockdown of serum TTR of up to 94% and showed that ALN-TTRsc was generally safe and well tolerated, thereby confirming human translation of our proprietary GalNAc-siRNA conjugate delivery platform. |
| 2013-09-23 | Alnylam Pharmaceuticals | Results Alnylam Reports Positive Clinical Results — with up to 94% Knockdown of Serum Transthyretin (TTR) — for ALN-TTRsc, a Subcutaneously Delivered RNAi Therapeutic for the Treatment of TTR-Mediated Amyloidosis (ATTR) alnylam.com ↗
Results show that ALN-TTRsc administration led to robust, consistent, and statistically significant (p < 0.01) knockdown of serum TTR protein levels of up to 94%. |
| 2013-07-11 | Alnylam Pharmaceuticals | Results Alnylam Reports Positive Top-Line Results for ALN-TTRsc, a Subcutaneously Administered RNAi Therapeutic Targeting Transthyretin (TTR) for the Treatment of TTR-Mediated Amyloidosis alnylam.com ↗
Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY), a leading RNAi therapeutics company, announced today positive top-line results from its ongoing Phase I trial of ALN-TTRsc, a subcutaneously administered RNAi therapeutic targeting the transthyretin (TTR) gene for the treatment of TTR-mediated amyloidosis (ATTR). |
| 2013-01-03 | Alnylam Pharmaceuticals | Regulatory Alnylam Files Clinical Trial Application to Initiate a Phase I Study for ALN-TTRsc, a Subcutaneously Administered RNAi Therapeutic Targeting Transthyretin (TTR) for the Treatment of TTR-Mediated Amyloidosis (ATTR) alnylam.com ↗ |
| 2012-08-06 | Alnylam Pharmaceuticals | Results Alnylam Presents New Data from its Conjugate Delivery Platform, Enabling Subcutaneous Administration of RNAi Therapeutics with Wide Therapeutic Index alnylam.com ↗
The research findings demonstrate potent and durable target gene silencing with subcutaneously administered GalNAc-conjugate siRNA from Alnylam’s ALN-TTRsc and ALN-AT3 pre-clinical programs. |
All press releases naming this drug 20 releases
Evidence & citations 6 cited values
Every value below carries the sentence it was read from. 4 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Revusiran | ClinicalTrials.gov intervention name — accepted as the source's own label NCT02595983 ↗ |
| Known as | ALN-TTRSC | “ENDEAVOUR: Phase 3 Multicenter Study of Revusiran (ALN-TTRSC) in Patients With Transthyretin (TTR) Mediated Familial Amyloidotic Cardiomyopathy (FAC)” NCT02319005 ↗1“Revusiran (ALN-TTRSC)” NCT02292186 ↗ |
| Action | Inhibit | “serum TTR reduction” PMID 32062791 ↗ Jun 2020 |
| Modality | Small interfering RNA (siRNA) | “an investigational RNA interference therapeutic targeting hepatic transthyretin (TTR) production” PMID 32062791 ↗ Jun 2020 |
| Route | Subcutaneous | “receive subcutaneous daily revusiran 500 mg” PMID 32062791 ↗ Jun 2020 |
| Target | TTR | “targeting hepatic transthyretin (TTR) production” PMID 32062791 ↗ Jun 2020 |