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LX7101

Phase 1

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

LX7101 target and mechanism

ModalitySmall molecule

Also known as LX7101 (0.125%)

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

LX7101 clinical trials

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?

LX7101 is an investigational small molecule developed by Lexicon Pharmaceuticals, Inc. (ticker LXRX) for Primary Open-angle Glaucoma. It is a topical ophthalmic formulation, referenced as LX7101 (0.125%), and is in Phase 1 clinical development. It has been studied in a single completed Phase 1 trial.

What is LX7101 used for?

LX7101 is being developed for Primary Open-angle Glaucoma, a condition involving elevated intraocular pressure and optic nerve damage. The completed Phase 1 study also enrolled subjects with Ocular Hypertension. It is investigational and has not been approved for commercial use in this or any other indication.

Who makes LX7101?

LX7101 is developed by Lexicon Pharmaceuticals, Inc., which trades on the Nasdaq under the ticker LXRX. Lexicon is the sponsor of the clinical program evaluating the compound in ophthalmology. The asset is a small molecule formulation designated LX7101 (0.125%).

What phase is LX7101 in?

LX7101 is in Phase 1 clinical development. Its only recorded trial, NCT01528111, is a completed Phase 1 study, and no active trials are currently listed. Because it remains investigational, LX7101 has not received FDA approval for Primary Open-angle Glaucoma or any other indication.

What clinical trials is LX7101 in?

LX7101 has been evaluated in one clinical trial, NCT01528111, titled a study to evaluate the safety, tolerability, and efficacy of LX7101 in subjects with Primary Open-angle Glaucoma or Ocular Hypertension. The Phase 1 trial was randomized, double-blind, and placebo-controlled, enrolled 63 participants in the United States, and is completed.

Is LX7101 the same as LX7101 (0.125%)?

Yes. LX7101 (0.125%) is an alternative designation for LX7101, referring to the 0.125% concentration of the ophthalmic formulation used in its clinical program. Both names refer to the same investigational small molecule developed by Lexicon Pharmaceuticals, Inc. for Primary Open-angle Glaucoma.