Drugs / SYL1001
Trials 5
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial · 1 met primary | ||||||
| Phase 1 | NCT01438281 | Jul → Nov 2011 | dry eye syndrome | Sylentis, S.A. | Completed | Met primary |
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT01776658 | Nov 2012 → Apr 2015 | dry eye syndrome | Sylentis, S.A. | Completed | No outcome recorded |
| Phase 21 trial · 1 met primary | ||||||
| Phase 2 | NCT02455999 | Jun 2015 → Mar 2016 | dry eye syndrome | Sylentis, S.A. | Completed | Met primary |
| Phase 32 trials · 1 met primary | ||||||
| Phase 3 | NCT05310422 | Mar 2022 → Oct 2023 | dry eye syndrome | Sylentis, S.A. | Completed | Met primary |
| Phase 3 | NCT03108664 | May 2017 → Oct 2018 | dry eye syndrome | Sylentis, S.A. | Completed | No outcome recorded |
| Comparator or background therapy1 trial | ||||||
| Phase 3 | NCT04819269 Comparator | May 2021 → Dec 2023 | Sjogren syndrome, dry eye syndrome | Sylentis, S.A. | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 12
| Date | Issuer | Release |
|---|---|---|
| 2023-12-18 | Sylentis, S.A. | Results Sylentis, a PharmaMar Group company, announces the FYDES study to evaluate the safety of tivanisiran in patients with dry eye disease has met its primary endpoint sylentis.com ↗
FYDES achieved the primary endpoint of the study by demonstrating the long-term safety of tivanisiran ophthalmic solution administration. |
| 2023-12-18 | PharmaMar | Results Sylentis, a PharmaMar Group company, announces the FYDES study to evaluate the safety of tivanisiran in patients with dry eye disease has met its primary endpoint pharmamar.com ↗
FYDES achieved the primary endpoint of the study by demonstrating the long-term safety of tivanisiran ophthalmic solution administration. |
| 2021-03-04 | Sylentis, S.A. | Regulatory FDA authorizes Sylentis (PharmaMar Group) to initiate Phase III trial with tivanisiran for the treatment of dry eye disease sylentis.com ↗
The study has been approved by the FDA in 30 days and will be part of the marketing authorization application. |
| 2021-03-04 | PharmaMar | Regulatory FDA authorizes Sylentis (PharmaMar Group) to initiate Phase III trial with tivanisiran for the treatment of dry eye disease pharmamar.com ↗
Sylentis, a PharmaMar Group company (MSE:PHM), announced today that the US FDA (Food and Drug Administration) has authorized the initiation of the Phase III clinical trial SYL1001_V with tivanisiran ophthalmic |
| 2019-05-06 | Sylentis, S.A. | Results Sylentis (PharmaMar Group) presents new results of tivanisiran for the treatment of dry eye disease sylentis.com ↗ |
| 2019-04-25 | Sylentis, S.A. | Results Sylentis (PharmaMar Group) at ARVO 2019 with results from two ophthalmic drugs: tivanisirán and SYL1801 sylentis.com ↗
The company will present results of the HELIX clinical trial with tivanisirán for the treatment of Dry Eye Syndrome, in which an improvement in central corneal damage and results in patients with Sjögren’s Syndrome are demonstrated. |
| 2019-01-31 | Sylentis, S.A. | Results Sylentis announces results of Phase 3 HELIX trial with tivanisiran for the treatment of Dry Eye Disease sylentis.com ↗ |
| 2018-05-03 | Sylentis, S.A. | Results Sylentis announces the clinical results of tivanisiran for the treatment of dry eye syndrome sylentis.com ↗
The studies carried out with tivanisiran showed an improvement in the inflammatory ocular parameters, tear quality, and a reduction in ocular pain, that is associated with dry eye syndrome |
| 2017-10-19 | Sylentis, S.A. | Regulatory The World Health Organization selects tivanisiran as the International Nonproprietary Name for SYL1001 sylentis.com ↗
This entails the designation of tivanisiran as the chosen INN for the compound SYL1001. |
| 2017-05-09 | Sylentis, S.A. | Results Sylentis announces new preclinical and clinical data for its SYL1001 molecule during ARVO 2017 sylentis.com ↗
The stability of the compound in various containers and conditions through time concludes that all the formats analyzed guarantee the integrity and specifications of the product. |
| 2016-03-14 | Sylentis, S.A. | Results Sylentis reports positive Phase II results with SYL1001 in treating ocular pain related to dry eye syndrome sylentis.com ↗
The results revealed that 1.125% was an optimal dose which achieved the best primary and secondary endpoints, reducing not only ocular pain but also conjunctival hyperaemia related to dry eye syndrome. |
| 2011-06-06 | Sylentis, S.A. | Regulatory Zeltia subsidiary Sylentis commences Phase I trials with its new compound SYL1001 to treat eye pain associated with dry eye syndrome sylentis.com ↗ |
All press releases naming this drug 15 releases
Evidence & citations 6 cited values
Every value below carries the sentence it was read from. 7 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | SYL1001 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT03108664 ↗ |
| Known as | Tivanisiran | ClinicalTrials.gov intervention name — accepted as the source's own label NCT05310422 ↗ |
| Known as | Tivanisiran sodium | “Tivanisiran sodium ophthalmic solution” NCT05310422 ↗1“Tivanisiran sodium ophthalmic solution” NCT04819269 ↗ |
| Modality | Small interfering RNA (siRNA) | “a short interfering (si) RNA” PMID 27893109 ↗ Nov 2016 |
| Route | Topical | “SYL1001 eye drops. topical administration” NCT01438281 ↗ |
| Target | TRPV1 | “SYL1001, a short interfering (si) RNA targeting the transient receptor potential cation channel subfamily V member 1 (TRPV1)” PMID 27893109 ↗ Nov 2016 |