Drugs / Diquafosol tetrasodium
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed | Japan (PMDA) | — | dry eye syndrome | 2021-08-30 | “announced today the filing for manufacturing and marketing approval of dry eye ophthalmic drug STN1008903 (diquafosol sodium) in Japan.” santen.com ↗ |
Trials 9
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial | ||||||
| Phase 1 | NCT03216096 | Sep 2017 → Feb 2018 | dry eye syndrome | Santen Pharmaceutical Co., Ltd. | Completed | No outcome recorded |
| Phase 21 trial · 1 met primary | ||||||
| Phase 2 | NCT01189032 | ? → Jul 2006 | dry eye syndrome | Santen Pharmaceutical Co., Ltd. | Completed | Met primary |
| Phase 33 trials · 2 met primary | ||||||
| Phase 3 | NCT00037661 | Apr 2002 → Mar 2003 | dry eye syndrome | Merck Sharp & Dohme LLC | Completed | No outcome recorded |
| Phase 3 | NCT00404131 | Mar → Dec 2001 | dry eye syndrome | Merck Sharp & Dohme LLC | Completed | Met primary |
| Phase 3 | NCT01240382 | ? → Feb 2008 | dry eye syndrome | Santen Pharmaceutical Co., Ltd. | Completed | Met primary |
| Phase not applicable4 trials · 1 met primary | ||||||
| — | NCT05720754 | Apr → Jul 2023 | dry eye syndrome | He Eye Hospital | Unknown | No outcome recorded |
| — | NCT04980144 | Mar → Aug 2023 | — | He Eye Hospital | Unknown | No outcome recorded |
| — | NCT05694026 | Mar → Jul 2023 | dry eye syndrome | He Eye Hospital | Completed | Met primary |
| — | NCT05682547 | Dec 2022 → Jun 2023 | — | He Eye Hospital | Completed | No outcome recorded |
| Comparator or background therapy1 trial | ||||||
| — | NCT02618304 Background | Apr 2015 → Feb 2016 | eye adnexa disorder | Yonsei University | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 1
| Date | Issuer | Release |
|---|---|---|
| 2022-06-20 | Santen Gmbh | Regulatory Santen receives manufacturing and marketing approval for the dry-eye treatment DIQUAS LX Ophthalmic Solution 3% in Japan - Improved formulation to reduce administration frequency to three-times daily, thus easing patients' burden - santen.com ↗
June 20, 2022, Santen Pharmaceutical Co., Ltd. (head office in Osaka City; hereinafter “Santen”) today announced that it has obtained manufacturing and marketing approval for the dry eye treatment DIQUAS LX Ophthalmic Solution 3% (diquafosol sodium) in Japan. |
All press releases naming this drug 2 releases
Evidence & citations 9 cited values
Every value below carries the sentence it was read from. 12 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Diquafosol Tetrasodium | “3% Diquafosol Tetrasodium eye drops” NCT02618304 ↗ |
| Known as | DE-089 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT01240382 ↗ |
| Known as | Diquafosol | “Diquafosol is a P2Y2 receptor agonist that has been shown to be effective in the treatment of dry eye disease (DED)” PMID 31834617 ↗ Dec 20191“Diquafosol ophthalmic solution (DQS) stimulates P2Y2 receptors on the ocular surface” NCT04980144 ↗ |
| Known as | DQS | “Diquafosol ophthalmic solution (DQS) stimulates P2Y2 receptors on the ocular surface” NCT05682547 ↗1“Diquafosol ophthalmic solution (DQS) stimulates P2Y2 receptors on the ocular surface” NCT04980144 ↗ |
| Known as | INS365 | “Double-masked, placebo-controlled safety and efficacy trial of diquafosol tetrasodium (INS365) ophthalmic solution for the treatment of dry eye.” PMID 15502479 ↗ Nov 2004 |
| Action | Activate | “a P2Y2 receptor agonist that stimulates fluid and mucin secretion on the ocular surface” PMID 15502479 ↗ Nov 2004 |
| Modality | Oligonucleotide (other) | “Diquafosol tetrasodium is a dinucleotide polyphosphate” NCT04980144 ↗ |
| Route | Topical | “when applied topically in subjects with dry eye disease” NCT00404131 ↗ |
| Target | P2RY2 | “Diquafosol ophthalmic solution (DQS) stimulates P2Y2 receptors on the ocular surface” NCT04980144 ↗ |