Product Description
a Novel Nanomicellar Formulation of Cyclosporine A for the Treatment of Keratoconjunctivitis Sicca (Sourced from: https://pubmed.ncbi.nlm.nih.gov/31361655/)
Mechanisms of Action: Unknown
Novel Mechanism: No
Modality: Small Molecule
Route of Administration: Ophthalmic
FDA Designation: *
Approval Status: Not Approved
Approved Countries: Australia | Canada | Hong Kong | New Zealand | United States
Approved Indications: None
Known Adverse Events: None
Company: Sun Pharma
Company Location:
Company CEO:
Additional Commercial Interests: None
Clinical Description
Countries in Clinic:
Active Clinical Trial Count:
Recent & Upcoming Milestones
Highest Development Phases
Phase 4: Dry Eye Syndromes|Keratoconjunctivitis Sicca|Cataract|Sjogren's Syndrome
Phase 3: Dry Eye Syndromes|Dry Eye Disease|Keratoconjunctivitis Sicca
Trial ID |
Trial |
Phase |
Trial Status |
Disease |
Primary Completion Date |
Probability of Success |
Latest Trial Update Date |
Data Updated |
|---|---|---|---|---|---|---|---|---|
NCT02845674 |
OTX-101-2016-002 | P3 |
Completed |
Keratoconjunctivitis Sicca|Dry Eye Syndromes |
2017-08-15 |
2021-11-18 |
Primary Endpoints|Treatments |
|
NCT02688556 |
Emerald | P3 |
Completed |
Keratoconjunctivitis Sicca|Dry Eye Syndromes |
2016-11-01 |
2021-11-18 |
Primary Endpoints |
|
NCT02254265 |
OTX-101-2014-001 | P3 |
Completed |
Dry Eye Disease|Dry Eye Syndromes|Keratoconjunctivitis Sicca |
2015-05-01 |
2021-11-18 |
Primary Endpoints|Treatments |
|
NCT06482177 |
COAT | P4 |
Completed |
Keratoconjunctivitis Sicca|Dry Eye Syndromes |
2024-06-05 |
2024-07-03 |
Primary Endpoints|Treatments |
|
NCT04835623 |
SP-001 | P4 |
Completed |
Keratoconjunctivitis Sicca|Sjogren's Syndrome|Dry Eye Syndromes |
2024-03-21 |
2024-04-17 |
Primary Completion Date|Primary Endpoints|Study Completion Date |
|
NCT04515329 |
STUDY20010206 | P4 |
Withdrawn |
Dry Eye Syndromes|Keratoconjunctivitis Sicca |
2023-12-08 |
2023-12-19 |
Patient Enrollment|Primary Completion Date|Primary Endpoints|Start Date|Study Completion Date|Treatments|Trial Status |
|
NCT04342988 |
Sun Cequa Accuracy 191118 | P4 |
Completed |
Cataract|Keratoconjunctivitis Sicca|Dry Eye Syndromes |
2020-12-31 |
2021-03-13 |
Patient Enrollment|Primary Completion Date|Primary Endpoints|Study Completion Date|Treatments|Trial Status |