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GLK-321 low dose

Phase 2

Demodex Blepharitis | Small molecule | Ophthalmology |Glaukos Corporation|Last Updated: Feb 27, 2026

Target and mechanism

ModalitySmall molecule

Also known as GLK-321 low dose BID

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment250

FDA Designations

No designations recorded

Clinical trial landscape

GLK-321 low dose · 1 trial · 1 indication

Phase 2 1
NCT07400965Evaluation of the Safety and Efficacy of GLK-321 in Subjects With Demodex BlepharitisDemodex Blepharitis
RECRUITING250 Analytics
PHASE2RECRUITING
Evaluation of the Safety and Efficacy of GLK-321 in Subjects With Demodex Blepharitis
Demodex BlepharitisUnlock trial analytics

Study Endpoints

Primary Endpoints

Percentage of study eyes with elimination of collarettes
6 weeks

Percentage of study eyes that had eyelash collarettes due to Demodex blepharitis at the onset of treatment who demonstrate absence of collarettes after 6 weeks of treatment

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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
GLK-321 low dose BIDEXPERIMENTALLow dose of GLK-321 administered twice daily (BID) to both eyes
GLK-321 mid dose BIDEXPERIMENTALMid dose of GLK-321 administered twice daily (BID) to both eyes
GLK-321 high dose BIDEXPERIMENTALHigh dose of GLK-321 administered twice daily (BID) to both eyes
GLK-321 high dose QDEXPERIMENTALHigh dose of GLK-321 administered once daily (QD) to both eyes
Placebo BIDPLACEBO_COMPARATORPlacebo administered twice daily (BID) to both eyes

Interventions

NameTypeDescription
GLK-321 low dose BIDDRUGTwice daily administration of low dose GLK-321 to both eyes
GLK-321 mid dose BIDDRUGTwice daily administration of mid dose GLK-321 to both eyes
GLK-321 high dose BIDDRUGTwice daily administration of high dose GLK-321 to both eyes
GLK-321 high dose QDDRUGOnce daily administration of high dose GLK-321 to both eyes
Placebo BIDDRUGTwice daily administration of placebo to both eyes
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Signs of Demodex blepharitis in at least one eye * Best Spectacle Corrected Visual Acuity (BSCVA) of 20/80 Snellen or better in each eye Exclusion Criteria: * Presence of eczema or dermatitis in the ocular region of either eye * Use of lid hygiene products within 14 days of ...

Countries:United States
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Frequently asked questions about GLK-321 low dose

What is GLK-321 low dose used for?

GLK-321 low dose is an investigational small molecule being developed for the treatment of Demodex Blepharitis, a common eyelid condition caused by Demodex mites. It is currently in Phase 2 clinical development and has not been approved by the FDA.

What does GLK-321 low dose target?

The specific molecular target of GLK-321 low dose has not been disclosed. It is a small molecule being studied for its safety and efficacy in treating Demodex Blepharitis, a condition associated with eyelid inflammation and mite infestation.

Who makes GLK-321 low dose?

GLK-321 low dose is being developed by Glaukos Corporation, a company traded on the New York Stock Exchange under the ticker symbol GKOS. The company is conducting a Phase 2 clinical trial to evaluate the drug in patients with Demodex Blepharitis.

What phase is GLK-321 low dose in?

GLK-321 low dose is in Phase 2 clinical development. It is an investigational drug and has not been approved by the FDA. The ongoing Phase 2 trial is actively recruiting participants in the United States.

What clinical trials is GLK-321 low dose in?

GLK-321 low dose is being evaluated in a single Phase 2 clinical trial with the identifier NCT07400965. This randomized, double-blind, placebo-controlled study is assessing the safety and efficacy of the drug in approximately 250 subjects with Demodex Blepharitis.

Is GLK-321 low dose the same as GLK-321 low dose BID?

Yes, GLK-321 low dose is also known as GLK-321 low dose BID. The term BID refers to the dosing frequency of twice a day, which is the regimen being studied in the ongoing Phase 2 clinical trial for Demodex Blepharitis.