Drugs / Diquafosol
Diquafosol
also known as
diquafosol tetrasodium · Diquafosol Sodium · INS365 · Diquas · Diquafosol ophthalmic sodium solution · Diquas-S · DQS
Trials 19
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 24 trials | ||||||
| Phase 2 | NCT06146881 | Oct 2022 → Dec 2023 | dry eye syndrome | Indonesia University | Unknown | No outcome recorded |
| Phase 2 | NCT01381731 | Apr → Jun 2005 | — | Merck Sharp & Dohme LLC | Terminated | No outcome recorded |
| Phase 2 | NCT00679718 | Jan → Jul 2000 | dry eye syndrome | Merck Sharp & Dohme LLC | Completed | No outcome recorded |
| Phase 2 | NCT00680108 | Sep 1999 → May 2000 | dry eye syndrome | Merck Sharp & Dohme LLC | Completed | No outcome recorded |
| Phase 36 trials · 1 met primary | ||||||
| Phase 3 | NCT06903884 | Feb 2026 → Jun 2028 expected | vernal keratoconjunctivitis | The University of Hong Kong | Recruiting | No outcome recorded |
| Phase 3 | NCT06427031 | Jul 2023 → May 2024 | dry eye syndrome | Taejoon Pharmaceutical Co., Ltd. | Completed | No outcome recorded |
| Phase 3 | NCT00831662 | Jan → Dec 2009 | dry eye syndrome | Merck Sharp & Dohme LLC | Completed | Met primary |
| Phase 3 | NCT00600288 | Jan → May 2008 | dry eye syndrome | Merck Sharp & Dohme LLC | Completed | No outcome recorded |
| Phase 3 | NCT00403975 | Jun → Nov 2004 | dry eye syndrome | Merck Sharp & Dohme LLC | Completed | No outcome recorded |
| Phase 3 | NCT00403715 | Feb 2001 → Sep 2002 | dry eye syndrome | Merck Sharp & Dohme LLC | Completed | No outcome recorded |
| Phase 42 trials | ||||||
| Phase 4 | NCT07297316 | Oct 2022 → Aug 2024 | dry eye syndrome | Korea University Anam Hospital | Completed | No outcome recorded |
| Phase 4 | NCT04668118 | Feb 2021 → Oct 2022 | VISS syndrome, asthenopia, dry eye syndrome | Peking University Third Hospital | Unknown | No outcome recorded |
| Phase not applicable7 trials | ||||||
| — | NCT07097922 | Aug 2025 → May 2026 overdue | dry eye syndrome | He Eye Hospital | Not yet recruiting | No outcome recorded |
| — | NCT06852105 | Feb 2025 → May 2026 overdue | dry eye syndrome | He Eye Hospital | Not yet recruiting | No outcome recorded |
| — | NCT06537349 | Aug → Dec 2024 overdue | dry eye syndrome | He Eye Hospital | Not yet recruiting | No outcome recorded |
| — | NCT05193331 | Apr → Aug 2023 | — | He Eye Hospital | Unknown | No outcome recorded |
| — | NCT05383612 | Aug 2022 → May 2024 | dry eye syndrome | Zhongshan Ophthalmic Center, Sun Yat-sen University | Unknown | No outcome recorded |
| — | NCT06560580 | Nov 2021 → Jul 2023 | dry eye syndrome | Tianjin Eye Hospital | Completed | No outcome recorded |
| — | NCT01101984 | Feb 2010 → Apr 2012 | dry eye syndrome | Santen Pharmaceutical Co., Ltd. | Completed | No outcome recorded |
| Comparator or background therapy7 trials | ||||||
| Phase 1/2 | NCT05346783 Comparator | Oct 2021 → Dec 2022 | dry eye syndrome | Taejoon Pharmaceutical Co., Ltd. | Unknown | No outcome recorded |
| Phase 3 | NCT04548427 Comparator | Sep 2020 → May 2021 | dry eye syndrome | Chong Kun Dang Pharmaceutical | Completed | No outcome recorded |
| Phase 4 | NCT07397949 Comparator | Mar → Dec 2026 expected | cataract, dry eye syndrome | Samsung Medical Center | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT07397936 Comparator | Aug 2024 → May 2025 | cataract, dry eye syndrome | Samsung Medical Center | Completed | No outcome recorded |
| — | NCT05456061 Comparator | Aug 2018 → Aug 2019 | dry eye syndrome, tear protein, anodal | Yonsei University | Completed | No outcome recorded |
| — | NCT03640351 Comparator | Aug 2017 → Feb 2019 | cataract, dry eye syndrome | Yonsei University | Completed | No outcome recorded |
| — | NCT02608489 Comparator | Jan 2014 → Jan 2015 | dry eye syndrome | Soonchunhyang University Hospital | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 3
| 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. |
| 2021-08-30 | Santen Gmbh | Regulatory Santen Files for Manufacturing and Marketing Approval of STN1008903 (diquafosol sodium) - Improved formulation to reduce the frequency of administration to ease patients' burden - santen.com ↗
Santen Pharmaceutical Co., Ltd. (Head office in Osaka; hereinafter “Santen”) announced today the filing for manufacturing and marketing approval of dry eye ophthalmic drug STN1008903 (diquafosol sodium) in Japan. |
| 2018-05-02 | RegeneRx Biopharmaceuticals, Inc. | Results ReGenTree Presents Results of a Comparison Study of RGN-259 and Approved Prescription Drugs for Dry Eye Syndrome in a Mouse Model at ARVO regenerx.com ↗
Such improvements with RGN-259 treatment were comparable to or better than that seen with approved prescription treatments such as cyclosporine A (Restasis®), lifitegrast (Xiidra®), and diquafosol (Diquas®), which are marketed in the USA or Japan. |
All press releases naming this drug 6 releases
Evidence & citations 11 cited values
Every value below carries the sentence it was read from. 28 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | diquafosol | “Diquafosol ophthalmic sodium solution, 1 drop 3 times a day” NCT06427031 ↗ |
| Known as | Diquafosol ophthalmic sodium solution | “Diquafosol ophthalmic sodium solution, 1 drop 3 times a day” NCT06427031 ↗ |
| Known as | Diquafosol Sodium | “3% Diquafosol Sodium Eye Drops (DIQUAS ophthalmic solution 3%; Santen Pharmaceutical Co. Ltd, Osaka, Japan)，3% diquafosol was administered six times a day for 12 weeks.” NCT05383612 ↗5“Effect of topical 3% diquafosol sodium on eyes with dry eye disease and meibomian gland dysfunction” PMID 29075094 ↗ Sep 2017 “Each patient was prescribed 3% (5 mL: 150 mg) diquafosol sodium eye drops” NCT06560580 ↗ |
| Known as | diquafosol tetrasodium | “the group 1 uses preservative free 3% diquafosol tetrasodium ophthalmic solution (Diquas-S; Santen Pharmaceutical Co, Ltd, Osaka, Japan) 6 times a day, the group 2 uses 3%...” NCT03640351 ↗7“Double-masked, placebo-controlled safety and efficacy trial of diquafosol tetrasodium (INS365) ophthalmic solution for the treatment of dry eye.” PMID 15502479 ↗ Nov 2004 “Diquafosol tetrasodium is a dinucleotide polyphosphate which a purinoceptor agonist” NCT05193331 ↗ “diquafosol tetrasodium (INS365) ophthalmic solution” NCT00680108 ↗ “diquafosol tetrasodium (INS365) ophthalmic solution” NCT00679718 ↗ “diquafosol tetrasodium (INS365) Ophthalmic Solution” NCT00403715 ↗ “diquafosol tetrasodium Ophthalmic Solution, 2%” NCT00600288 ↗ “diquafosol tetrasodium ophthalmic solution 2%” NCT01381731 ↗ |
| Known as | Diquas | “the group 1 uses preservative free 3% diquafosol tetrasodium ophthalmic solution (Diquas-S; Santen Pharmaceutical Co, Ltd, Osaka, Japan) 6 times a day, the group 2 uses 3%...” NCT03640351 ↗2“3% Diquafosol Sodium Eye Drops (DIQUAS ophthalmic solution 3%; Santen Pharmaceutical Co. Ltd, Osaka, Japan)，3% diquafosol was administered six times a day for 12 weeks.” NCT05383612 ↗ “Diquafosol (Diquas)” NCT02608489 ↗ |
| Known as | Diquas-S | “the group 1 uses preservative free 3% diquafosol tetrasodium ophthalmic solution (Diquas-S; Santen Pharmaceutical Co, Ltd, Osaka, Japan) 6 times a day, the group 2 uses 3%...” NCT03640351 ↗ |
| Known as | DQS | “Diquafosol ophthalmic solution (DQS) stimulates P2Y2 receptors on the ocular surface” NCT05193331 ↗ |
| 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 20043“diquafosol tetrasodium (INS365) Ophthalmic Solution” NCT00403715 ↗ “diquafosol tetrasodium (INS365) ophthalmic solution” NCT00680108 ↗ “diquafosol tetrasodium (INS365) ophthalmic solution” NCT00679718 ↗ |
| Action | Activate | “a P2Y2 receptor agonist that stimulates fluid and mucin secretion on the ocular surface” PMID 15502479 ↗ Nov 2004 |
| Modality | Oligonucleotide (other) | “Diquafosol is a dinucleotide derivative” NCT03640351 ↗ |
| Route | Topical | “when applied topically in subjects with dry eye disease” NCT00403715 ↗ |