Drugs / RADAVIRSEN
Trials 2
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 1 | NCT01747148 | Dec 2012 → Jun 2016 | influenza | National Institute of Allergy and Infectious Diseases (NIAID) | Completed | No outcome recorded |
| Phase 1 | NCT01375985 | Jun → Aug 2011 | influenza | Sarepta Therapeutics, Inc. | Terminated | No outcome recorded Stop: Enrollment |
News releases announcing trial results or a regulatory action · 6
| Date | Issuer | Release |
|---|---|---|
| 2014-11-06 | Sarepta Therapeutics, Inc. | Results Sarepta Therapeutics Announces Third Quarter 2014 Financial Results and Recent Corporate Developments sarepta.com ↗
Results showed that AVI-7100 was well-tolerated up to the highest dose tested of 8 mg/kg, with no reported serious or clinically significant adverse events. |
| 2014-09-30 | Sarepta Therapeutics, Inc. | Results Sarepta Therapeutics Announces Favorable Safety Results from Phase I Clinical Study of Influenza Drug Candidate sarepta.com ↗
Results showed that AVI-7100 was well-tolerated with no reported serious or clinically significant adverse events. |
| 2012-03-30 | Sarepta Therapeutics, Inc. | Results Data From AVI BioPharma's Infectious Disease Programs to Be Presented at the 22nd European Congress of Clinical Microbiology and Infectious Diseases sarepta.com ↗
Together, the data demonstrate both post exposure and prophylactic efficacy of AVI-7100 in influenza virus-infected mouse and ferret models |
| 2011-05-05 | Sarepta Therapeutics, Inc. | Regulatory AVI BioPharma Announces First Quarter 2011 Financial Results sarepta.com ↗
FDA Clears AVI-7100 Influenza Drug Candidate to Proceed with Phase 1 Study |
| 2010-10-20 | Sarepta Therapeutics, Inc. | Results Data From AVI BioPharma's RNA-Based Influenza and Dengue Virus Programs to Be Presented at 48th Annual Meeting of Infectious Diseases Society of America sarepta.com ↗ |
| 2010-08-24 | Sarepta Therapeutics, Inc. | Results AVI BioPharma Announces Positive Results Against Human Pandemic H1N1 Influenza Virus in Preclinical Studies of AVI-7100 sarepta.com ↗
An analysis of the data from the studies demonstrated statistically significant reductions in average viral titer versus a saline control and a control with Tamiflu(R), a standard of care drug. |
All press releases naming this drug 7 releases
Evidence & citations 4 cited values
Every value below carries the sentence it was read from. 3 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | RADAVIRSEN | ChEMBL registry synonym — accepted as the source's own label CHEMBL4297897 ↗ |
| Known as | AVI-7100 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT01747148 ↗ |
| Modality | Antisense oligonucleotide | “phosphorodiamidate morpholino antisense oligomers” NCT01375985 ↗ |
| Route | Intravenous | “Single intravenous administration” NCT01375985 ↗ |