Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
SHP639 · 1 trial · 2 indications
An adverse event (AE) is any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. TEAEs were defined as AEs with a start date on or after the first dose of double-blind investigational product or a start date before the date of the first dose of double-blind investigational product that increased in severity or after the date of the first dose.
| Arm | Type | Description |
|---|---|---|
| SHP639 Ophthalmic Solution Arm (n=60) | EXPERIMENTAL | Participants are divided into groups called cohorts. There will be approximately 12 cohorts, each consisting of 7 participants. In each cohort 5 out of 7 participants will be assigned a specified concentration of SHP639 (0.1%, 0.3%, or 0.6%) ophthalmic solution and a specific dosing schedule (the study participants will be instructed to insill the study drug one, two, three, or four times a day) in both eyes during the study. |
| Vehicle Ophthalmic Arm (n=24) | PLACEBO_COMPARATOR | In each cohort 2 out of 7 participants will be assigned a placebo ophthalmic solution matched to 0.1%, 0.3%, and 0.6% SHP639 ophthalmic solution and specific dosing schedule (the study participants will be instructed to instill the study drug one, two, three, or four times a day) in both eyes during the study. |
| Name | Type | Description |
|---|---|---|
| SHP639 (n=60) | DRUG | Drug SHP639 is a 9-amino acid, synthetic, C-type natriuretic peptide (CNP) analog. |
| Placebo Comparator (n=24) | DRUG | Drug: Vehicle Ophthalmic placebo solution of the same composition as the test product. |
Inclusion Criteria: 1. Participants must provide written, signed and dated informed consent to participate in the study in accordance with the International Council for Harmonisation (ICH) Good Clinical Practice (GCP) Guideline E6(R1) and applicable regulations, before completing any study-related ...
SHP639 is an investigational small molecule being developed as an eye drop for the treatment of primary open-angle glaucoma (POAG) and ocular hypertension. It is designed to lower high eye pressure in adults. The drug is currently in clinical development and has not been approved by regulatory authorities.
SHP639 is being developed by Takeda Pharmaceutical Company Limited, a global biopharmaceutical company listed on the Tokyo Stock Exchange under the ticker TAK. The drug is an investigational small molecule administered as an eye drop for the treatment of primary open-angle glaucoma and ocular hypertension.
SHP639 is in Phase 1 clinical development. A Phase 1 study of the drug has been completed, evaluating its safety and efficacy in adults with high eye pressure or primary open-angle glaucoma. The drug remains investigational and has not received regulatory approval.
SHP639 has one completed clinical trial, registered as NCT03131167. This Phase 1 study, titled 'Study of SHP639 Eye Drops in Adults With High Eye Pressure or Primary Open-angle Glaucoma,' enrolled 63 participants in the United States. The trial was randomized, double-blind, and placebo-controlled.
No, SHP639 is not FDA approved. It is an investigational drug currently in Phase 1 clinical development. A Phase 1 trial has been completed, but the drug has not yet received marketing authorization from the FDA or any other regulatory agency.