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GLK-221

Phase 2

Keratoconus | Small molecule | Ophthalmology |Glaukos Corporation|Last Updated: Feb 10, 2026

Target and mechanism

ModalitySmall molecule

Also known as GLK-221 Ophthalmic Solution

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment100

FDA Designations

No designations recorded

Clinical trial landscape

GLK-221 · 1 trial · 1 indication

Phase 2 1
NCT07400952Placebo-controlled Study to Evaluate the Safety and Efficacy of GLK-221 Ophthalmic Solution in Subjects With KeratoconusKeratoconus
RECRUITING100 Analytics
PHASE2RECRUITING
Placebo-controlled Study to Evaluate the Safety and Efficacy of GLK-221 Ophthalmic Solution in Subjects With Keratoconus
KeratoconusUnlock trial analytics

Study Endpoints

Primary Endpoints

Mean change from baseline in maximum corneal curvature
16 weeks
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
GLK-221 Ophthalmic SolutionEXPERIMENTALGLK-221 Ophthalmic Solution administered topically twice daily to both eyes
PlaceboPLACEBO_COMPARATORPlacebo Ophthalmic Solution administered topically twice daily to both eyes

Interventions

NameTypeDescription
GLK-221 Ophthalmic SolutionDRUGGLK-221 Ophthalmic Solution administered twice daily to both eyes
Placebo Ophthalmic SolutionDRUGPlacebo Ophthalmic Solution administered twice daily to both eyes
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Eligibility Criteria

Age Range18 Years to 55 Years
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Be ≥ 18 and ≤ 55 years of age * Diagnosis of keratoconus in the study eye Exclusion Criteria: * Pregnant, lactating or planning a pregnancy * Currently enrolled, or within 30 days prior to Screening were enrolled, in another investigational drug or device trial

Countries:United States
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Frequently asked questions about GLK-221

What is GLK-221 used for?

GLK-221 is an investigational ophthalmic solution being developed for the treatment of keratoconus, a progressive eye condition that thins and bulges the cornea. It is a small molecule therapy administered as eye drops. GLK-221 is currently in Phase 2 clinical development and has not been approved by regulatory authorities.

Who makes GLK-221?

GLK-221 is being developed by Glaukos Corporation, a company traded on the New York Stock Exchange under the ticker symbol GKOS. Glaukos is conducting a Phase 2 clinical trial to evaluate the safety and efficacy of GLK-221 ophthalmic solution in patients with keratoconus.

What phase is GLK-221 in?

GLK-221 is in Phase 2 clinical development. It is an investigational drug, meaning it has not been approved by the FDA or other regulatory agencies. The ongoing Phase 2 trial is actively recruiting participants in the United States to assess the safety and efficacy of GLK-221 for keratoconus.

What clinical trials is GLK-221 in?

GLK-221 is being studied in a Phase 2 clinical trial registered as NCT07400952. This is a randomized, double-blind, placebo-controlled study evaluating the safety and efficacy of GLK-221 ophthalmic solution in subjects with keratoconus. The trial plans to enroll 100 participants aged 18 years and older in the United States.

Is GLK-221 the same as GLK-221 Ophthalmic Solution?

Yes, GLK-221 and GLK-221 Ophthalmic Solution refer to the same investigational drug. The ophthalmic solution is the formulation being tested in clinical trials for keratoconus. The drug is administered as eye drops and is currently in Phase 2 development by Glaukos Corporation.