Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
iNexin · 1 trial · 1 indication
Assessed using: Visual Acuity (VA) (ETDRS), Slit-lamp biomicroscopy, Adverse Event Query, Dilated Fundoscopy Interocular Pressure
Assessed using: Ora Calibra Drop Comfort Assessments
| Arm | Type | Description |
|---|---|---|
| iNexin™ (0.08% aCT1) | EXPERIMENTAL | 36 eligible subjects will be randomized to Vehicle or one of three concentrations of iNexin™ to be administered bilaterally BID for 15 days (from Visit 2 to the evening of Visit 4). Subjects will be randomized 2:1 for each active concentration to Vehicle. During a 7-day study run-in period prior to randomization, all subjects will receive Vehicle eye drops (Vehicle) bilaterally BID (from Visit 1 to the evening before Visit 2). |
| iNexin™ (0.4% aCT1) | EXPERIMENTAL | 36 eligible subjects will be randomized to Vehicle or one of three concentrations of iNexin™ to be administered bilaterally BID for 15 days (from Visit 2 to the evening of Visit 4). Subjects will be randomized 2:1 for each active concentration to Vehicle. During a 7-day study run-in period prior to randomization, all subjects will receive Vehicle eye drops (Vehicle) bilaterally BID (from Visit 1 to the evening before Visit 2). |
| iNexin™ (2.0% aCT1) | EXPERIMENTAL | 36 eligible subjects will be randomized to Vehicle or one of three concentrations of iNexin™ to be administered bilaterally BID for 15 days (from Visit 2 to the evening of Visit 4). Subjects will be randomized 2:1 for each active concentration to Vehicle. During a 7-day study run-in period prior to randomization, all subjects will receive Vehicle eye drops (Vehicle) bilaterally BID (from Visit 1 to the evening before Visit 2). |
| Vehicle (eye drop formulation without aCT1) | PLACEBO_COMPARATOR | 36 eligible subjects will be randomized to Vehicle or one of three concentrations of iNexin™ to be administered bilaterally BID for 15 days (from Visit 2 to the evening of Visit 4). Subjects will be randomized 2:1 for each active concentration to Vehicle. During a 7-day study run-in period prior to randomization, all subjects will receive Vehicle eye drops (Vehicle) bilaterally BID (from Visit 1 to the evening before Visit 2). |
| Name | Type | Description |
|---|---|---|
| iNexin™ (0.08% aCT1) | DRUG | 36 eligible subjects will be randomized to Vehicle or one of three concentrations of iNexin™ to be administered bilaterally BID for 15 days (from Visit 2 to the evening of Visit 4). Subjects will be randomized 2:1 for each active concentration to Vehicle.randomized 7:3 for each active concentration to Vehicle. |
| iNexin™ (0.4% aCT1) | DRUG | 36 eligible subjects will be randomized to Vehicle or one of three concentrations of iNexin™ to be administered bilaterally BID for 15 days (from Visit 2 to the evening of Visit 4). Subjects will be randomized 2:1 for each active concentration to Vehicle. |
| iNexin™ (2.0% aCT1) | DRUG | 36 eligible subjects will be randomized to Vehicle or one of three concentrations of iNexin™ to be administered bilaterally BID for 15 days (from Visit 2 to the evening of Visit 4). Subjects will be randomized 2:1 for each active concentration to Vehicle. |
| Vehicle (eye drop formulation without aCT1) | DRUG | 36 eligible subjects will be randomized to Vehicle or one of three concentrations of iNexin™ to be administered bilaterally BID for 15 days (from Visit 2 to the evening of Visit 4). Subjects will be randomized 2:1 for each active concentration to Vehicle. During a 7-day study run-in period prior to randomization, all subjects will receive Vehicle eye drops (Vehicle) bilaterally BID (from Visit 1 to the evening before Visit 2). |
Inclusion Criteria: Subjects must meet all the following requirements to be eligible for enrollment into the study. 1. Be at least 18 years of age; 2. Provide written informed consent; 3. Have a self-reported history of dry eye for at least 6 months prior to Visit 1; 4. Have a history of use or de...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| AbbVie, Inc. | ABBV | 2 | PHASE3 | ABBV-444, REFRESH OPTIVE UD |
| Vanda Pharmaceuticals Inc. | VNDA | 1 | PHASE2 | VSJ-110 |
| Oculis Holding AG | OCS | 1 | PHASE2 | licaminlimab |
| Alcon AG | ALC | 1 | N/A | Undisclosed |
| Harrow, Inc. | HROW | 1 | - | Undisclosed |
iNexin is an investigational small molecule being developed for the treatment of dry eye disease. It is designed to address both the signs and symptoms associated with the condition. As of the latest available information, iNexin is in Phase 1 clinical development and has not been approved by regulatory authorities.
iNexin is being developed by United Therapeutics Corporation, a publicly traded company listed on the NASDAQ under the ticker symbol UTHR. The company is conducting clinical research to evaluate the safety, tolerability, and efficacy of iNexin for dry eye disease.
iNexin is currently in Phase 1 clinical development. A Phase 1 trial has been completed, which evaluated the safety, tolerability, and efficacy of iNexin in patients with dry eye disease. The drug remains investigational and is not yet approved for commercial use.
iNexin has been studied in one completed Phase 1 clinical trial registered as NCT05031806. This trial, conducted in the United States, enrolled 30 participants with dry eye disease. The study was randomized, double-blind, and placebo-controlled, and it evaluated the safety, tolerability, and efficacy of iNexin for treating the signs and symptoms of dry eye disease.
iNexin is not FDA approved. It is an investigational drug that has completed a Phase 1 clinical trial for dry eye disease. Further clinical development and regulatory review would be required before iNexin could be considered for approval.