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LX7101

Phase 1

Primary Open-angle Glaucoma | Small molecule | Ophthalmology |Lexicon Pharmaceuticals, Inc.|Last Updated: Sep 14, 2015

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment63

FDA Designations

No designations recorded

Clinical trial landscape

LX7101 · 1 trial · 2 indications

Phase 1 1
NCT01528111Study to Evaluate the Safety, Tolerability, and Efficacy of LX7101 in Subjects With Primary Open-angle Glaucoma or Ocular HypertensionPrimary Open-angle Glaucoma
COMPLETED63 Analytics
PHASE1COMPLETED
Study to Evaluate the Safety, Tolerability, and Efficacy of LX7101 in Subjects With Primary Open-angle Glaucoma or Ocular Hypertension
Primary Open-angle GlaucomaUnlock trial analytics

Study Endpoints

Primary Endpoints

Number of subjects experiencing an adverse event
15 Days

Secondary Endpoints

Mean Intraocular Pressure (IOP) in the study eye
Days 1, 3, 7, 10, 14, 15
Best Corrected Visual Acuity (BCVA)
Days 1, 3, 7, 10, 14, 15
Slit lamp biomicroscopy exam (SLE)
Days 1, 3, 7, 10, 14, 15
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Low dose LX7101EXPERIMENTALDays 1-3: once daily dose in study eye (eye with highest IOP); Days 4-7: once daily dose in study eye (eye with highest IOP) and fellow eye (other eye); Days 8-14: twice daily dose in study eye (eye with highest IOP) and fellow eye (other eye)
High dose LX7101EXPERIMENTALDays 1-3: once daily dose in study eye (eye with highest IOP); Days 4-7: once daily dose in study eye (eye with highest IOP) and fellow eye (other eye); Days 8-14: twice daily dose in study eye (eye with highest IOP) and fellow eye (other eye)
LX7101 VehiclePLACEBO_COMPARATORDays 1-3: once daily dose in study eye (eye with highest IOP); Days 4-7: once daily dose in study eye (eye with highest IOP) and fellow eye (other eye); Days 8-14: twice daily dose in study eye (eye with highest IOP) and fellow eye (other eye)

Interventions

NameTypeDescription
LX7101 (0.125%)DRUGSubjects will receive 0.125% LX7101
LX7101 (0.25%)DRUGSubjects will receive 0.25% LX7101
LX7101 VehicleDRUGSubjects will receive vehicle
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites5

Inclusion Criteria: * Adults ≥18 years of age * Documented diagnosis of POAG or OHT, in both eyes * Willing and able to provide written informed consent Exclusion Criteria: * History of any form of glaucoma in either eye, other than POAG * Subjects who are unwilling or unable to discontinue conta...

Countries:United States
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Frequently asked questions about LX7101

What is LX7101 used for?

LX7101 is an investigational small molecule being developed for primary open-angle glaucoma, a condition that damages the optic nerve. It was studied in patients with primary open-angle glaucoma or ocular hypertension. The drug is in Phase 1 clinical development and is not yet approved by the FDA.

What does LX7101 target?

LX7101 is a small molecule, but its specific molecular target has not been disclosed. It is being investigated for its safety, tolerability, and efficacy in lowering eye pressure in patients with primary open-angle glaucoma or ocular hypertension. The mechanism of action is not publicly detailed.

Who makes LX7101?

LX7101 is being developed by Lexicon Pharmaceuticals, Inc., a biopharmaceutical company. The company's stock trades under the ticker symbol LXRX. The drug is in Phase 1 clinical development for primary open-angle glaucoma.

What phase is LX7101 in?

LX7101 is in Phase 1 clinical development. It has completed one Phase 1 trial, and the drug remains investigational, meaning it has not been approved by the FDA. The completed trial evaluated the drug's safety, tolerability, and efficacy in patients with primary open-angle glaucoma or ocular hypertension.

What clinical trials is LX7101 in?

LX7101 has one completed Phase 1 clinical trial, identified as NCT01528111. This study evaluated the safety, tolerability, and efficacy of LX7101 in subjects with primary open-angle glaucoma or ocular hypertension. The trial was randomized, double-blind, and placebo-controlled, enrolling 63 participants in the United States.