Drugs / vezocolmitide
vezocolmitide
Trials 1
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 31 trial | ||||||
| Phase 3 | NCT06178679 | Dec 2023 → Jun 2024 | dry eye syndrome | ORA, Inc. | Unknown | No outcome recorded |
| Comparator or background therapy1 trial | ||||||
| Phase 2 | NCT05241470 Comparator | May → Oct 2021 | dry eye syndrome | Stuart Therapeutics, Inc. | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 6
| Date | Issuer | Release |
|---|---|---|
| 2023-03-09 | Stuart Therapeutics, Inc. | Results Stuart Therapeutics, Inc. Announces Upcoming Presentations at ARVO 2023 Annual Meeting stuarttherapeutics.com ↗
The results show significant improvement in corneal nerve and tissue health in an atropine / desiccation chamber damage model as a result of treatment with certain CMPs, the active ingredient in the company’s ST-100 drug candidate for dry eye disease. |
| 2022-07-18 | Stuart Therapeutics, Inc. | Regulatory Stuart Therapeutics Announces Successful Outcome from Type C Meeting with FDA stuarttherapeutics.com ↗
In addition, the FDA accepted the overall development plan proposed by Stuart. |
| 2022-01-03 | Stuart Therapeutics, Inc. | Results Stuart Therapeutics, Inc. Announces Successful Phase 2 Clinical Trial Results of its Novel Dry Eye Candidate ST-100 stuarttherapeutics.com ↗
ST-100 also demonstrated significant results in several symptoms and ocular surface staining scores as early as treatment day seven in both the intent to treat population, as well as the treated patient sub-populations. |
| 2021-03-19 | Stuart Therapeutics, Inc. | Regulatory Stuart Therapeutics Announces Receipt of Study May Proceed Letter from U.S. FDA for ST-100 Dry Eye Disease Phase 2 Clinical Trial stuarttherapeutics.com ↗
As a result of this review, the FDA has issued a No-Holds, Study May Proceed letter to Stuart, permitting the company to begin its Phase 2 clinical trial on ST-100. |
| 2018-10-04 | Stuart Therapeutics, Inc. | Results Stuart Therapeutics Announces Corneal Epithelial Healing and Organization Pre-Clinical Results for its Potential Dry Eye Therapeutic stuarttherapeutics.com ↗
These results are further support for PolyCol as a rapid healing agent for damage ocular surface, and a promising therapeutic for signs and symptoms of dry eye disease. |
| 2018-09-17 | Stuart Therapeutics, Inc. | Results Stuart Therapeutics Announces Important Pre-Clinical Results for ST-100 stuarttherapeutics.com ↗
Mouse eye wound tests conducted at the University of Louisville demonstrated rapid, high quality healing of corneal wounds, results that support Stuart’s development of PolyCol as a potential therapeutic for dry eye disease (DED) and other ocular surface indications. |
All press releases naming this drug 8 releases
Evidence & citations 6 cited values
Every value below carries the sentence it was read from. 3 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | vezocolmitide | ClinicalTrials.gov intervention name — accepted as the source's own label NCT06178679 ↗ |
| Known as | ST-100 | “ST-100 (vezocolmitide) Ophthalmic Solution 60 μg/ml” NCT06178679 ↗ |
| Known as | ST-100 Ophthalmic Solution | “Low dose ST-100 Ophthalmic Solution: 1 drop twice daily (BID) in each eye” NCT05241470 ↗ |
| Known as | Vezocolmitida | ChEMBL registry synonym — accepted as the source's own label CHEMBL6068188 ↗ |
| Modality | Protein / enzyme biologic | — CHEMBL6068188 ↗ |
| Route | Topical | “topical ophthalmic drops administered bilaterally BID” NCT05241470 ↗ |