Drugs / bamosiran
Trials 4
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial | ||||||
| Phase 1 | NCT00990743 | Sep 2009 → Jun 2010 | glaucoma, ocular hypertension | Sylentis, S.A. | Completed | No outcome recorded |
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT01227291 | Oct 2010 → Mar 2012 | glaucoma, ocular hypertension | Sylentis, S.A. | Completed | No outcome recorded |
| Phase 22 trials · 1 missed | ||||||
| Phase 2 | NCT02250612 | Oct 2014 → Aug 2015 | ocular hypertension, open-angle glaucoma | Sylentis, S.A. | Completed | Missed primary |
| Phase 2 | NCT01739244 | Jul 2012 → May 2013 | ocular hypertension, open-angle glaucoma | Sylentis, S.A. | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 5
| Date | Issuer | Release |
|---|---|---|
| 2015-10-02 | Sylentis, S.A. | Results Sylentis announces top-line results from Phase II study SYLTAG for RNAi drug bamosiran (SYL040012) in Glaucoma sylentis.com ↗
After 28 days of treatment, the four groups treated with bamosiran (0.375%, 0.75%, 1.125% y 1.5%) showed a similar reduction in the IOP. |
| 2014-07-17 | Sylentis, S.A. | Regulatory Sylentis receives authorisation to commence Phase IIb clinical trial with bamosiran (SYL040012) for treating ocular hypertension associated with glaucoma sylentis.com ↗
Madrid, 17 July 2014: Grupo Zeltia (MC:ZEL) has announced today that Sylentis, a pioneer in the research and development of new drugs based on gene silencing through RNA interference (RNAi), has been authorised by the Estonian authorities to commence a Phase IIb trial with bamosiran (SYL040012) for the treatment of glaucoma and ocular hypertension. |
| 2013-06-07 | Sylentis, S.A. | Results Zeltia announces that subsidiary Sylentis has attained the primary endpoint of the Phase IIa clinical trial with its compound SYL040012. sylentis.com ↗
The 300 microgram dose of SYL040012 was found to produce a statistically significant reduction in intraocular pressure with respect to the placebo. |
| 2012-03-09 | Sylentis, S.A. | Results Sylentis participates in the 7th Spanish Conference on Glaucoma (SEG) sylentis.com ↗
Madrid, 9 March 2011: Sylentis (MC:ZEL) presented the main results of its Phase I trial on safety and tolerance of its product SYL040012; the compound proved to be safe in the trial conditions. |
| 2010-09-06 | Sylentis, S.A. | Regulatory Sylentis receives authorisation to commence a new Phase I/IIclinical trial with SYL040012 for treating elevated intraocular pressure and glaucoma sylentis.com ↗
Sylentis, a biopharmaceutical subsidiary of Grupo Zeltia (MC: ZEL) and a pioneer in the research and development of new drugs based on gene silencing (interference RNA, RNAi), has received authorisation from the Spanish Medicines and Health Products Agency to commence a second Phase I/II clinical trial with SYL040012 for treating ocular hypertension. |
All press releases naming this drug 6 releases
Evidence & citations 3 cited values
Every value below carries the sentence it was read from. 4 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | bamosiran | “1 drop of 0.375% SYL040012 (bamosiran)” NCT02250612 ↗ |
| Known as | SYL040012 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT00990743 ↗ |
| Route | Other | “in ophthalmic drops solution” NCT00990743 ↗ |