Data updated: May 26, 2026
VERKAZIA (cyclosporine)
Calcineurin Inhibitors
Trial Activity: Declining 20 active trials
Ophthalmology
Approved 2021-06-23
VERKAZIA is indicated for the treatment of Vernal Keratoconjunctivitis.
Source: FDA Label • HARROW EYE
Development Insights
Fred Hutchinson Cancer Center conducting 23 trials (19%)
377 indications explored (Broad Platform)
→ myelodysplastic syndrome (12 trials)
→ healthy (12 trials)
→ acute myeloid leukemia (11 trials)
1
Indication
--
Phase 3 Trials
4
Years on Market
Details
- Status
- Prescription
- First Approved
- 2021-06-23
- Patent Cliff
- 2029
- Routes
- OPHTHALMIC
- Dosage Forms
- EMULSION
VERKAZIA Approval History
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
1 FDA actions from 2021 to 2021
What VERKAZIA Treats
1 indicationsVERKAZIA is approved for 1 conditions since its original approval in 2021. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Vernal Keratoconjunctivitis
Source: FDA Label
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Clinical Trial Registry
121 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT07566377 | 26-168 | Ph 2 | recruiting | Cord Blood Transplantation in Children and Young Adults With Blood Cancer |
| NCT04888741 MoTD | RG_19-116 | Ph 2 | recruiting | Methods of T Cell Depletion Trial (MoTD) |
| NCT01231412 results posted | 2448.00 NCI-2010-02035, 2448.00 | Ph 3 | completed | Graft-Versus-Host Disease Prophylaxis in Treating Patients With Hematologic Malignancies Undergoing Unrelated Donor Peripheral Blood Stem Cell Transplant |
| NCT01624805 | 2012-0334 NCI-2012-01096, 2012-0334 | Ph 2 | recruiting | Methylprednisolone, Horse Anti-Thymocyte Globulin, Cyclosporine, Filgrastim, and/or Pegfilgrastim or Pegfilgrastim Biosimilar in Treating Patients With Aplastic Anemia or Low or Intermediate-Risk Myelodysplastic Syndrome |
| NCT04488081 I-SPY_COVID | I-SPY-COVID | Ph 2 | active not recruiting | I-SPY COVID-19 TRIAL: An Adaptive Platform Trial for Critically Ill Patients |
| NCT03970096 | RG1005364 9749, NCI-2019-03188 | Ph 2 | recruiting | Graft Versus Host Disease-Reduction Strategies for Donor Blood Stem Cell Transplant Patients With Acute Leukemia or Myelodysplastic Syndrome (MDS) |
| NCT06752694 | RG1124040 NCI-2024-06524, 20575 | Ph 2 | recruiting | Ruxolitinib Based GVHD Prophylaxis Regimen Before, During, and After Hematopoietic Cell Transplantation in Older Adult Patients With Acquired Aplastic Anemia |
| NCT04304820 results posted | 200033 20-H-0033 | Ph 2 | recruiting | Early Initiation of Oral Therapy With Cyclosporine and Eltrombopag for Treatment Naive Severe Aplastic Anemia (SAA) |
| NCT04375631 | RG1006914 NCI-2020-02616, RG1006914 | Ph 1 | recruiting | CLAG-M or FLAG-Ida Chemotherapy and Reduced-Intensity Conditioning Donor Stem Cell Transplant for the Treatment of Relapsed or Refractory Acute Myeloid Leukemia, Myelodysplastic Syndrome, or Chronic Myelomonocytic Leukemia |
| NCT04195633 | RG1005742 NCI-2019-07697, 10343 | Ph 2 | recruiting | Donor Stem Cell Transplant With Treosulfan, Fludarabine, and Total-Body Irradiation for the Treatment of Hematological Malignancies |
| NCT05600426 TransIT | IRB-2020-0438 1UG3HL157564-01A1, 1U24HL157560-01A1 | Ph 3 | active not recruiting | A Trial Comparing Unrelated Donor BMT With IST for Pediatric and Young Adult Patients With Severe Aplastic Anemia (TransIT, BMT CTN 2202) |
| NCT06837259 | C4921008 2024-520126-11-00 | Ph 1 | completed | A Study to Learn if Study Medicines Called Cyclosporine and Clarithromycin Affect How the Body Processes the Other Study Medicine Called PF-07328948 in Healthy Adults |
| NCT06013423 | RG1123652 NCI-2023-05598, FHIRB0020219 | Ph 2 | recruiting | Cord Blood Transplant, Cyclophosphamide, Fludarabine, and Total-Body Irradiation in Treating Patients With High-Risk Hematologic Diseases |
| NCT07352566 | 25-43621 | Ph 4 | not yet recruiting | Utilization of a Microdevice for Psoriasis and Atopic Dermatitis |
| NCT03128034 | 9595 NCI-2017-00452, 9595 | Ph 1, Ph 2 | recruiting | 211^At-BC8-B10 Before Donor Stem Cell Transplant in Treating Patients With High-Risk Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia, Myelodysplastic Syndrome, or Mixed-Phenotype Acute Leukemia |
| NCT04743739 | iMN RTX plus CsA | Ph 3 | terminated | Rituximab Combined With Cyclosporine Versus Rituximab Alone in the Treatment of iMN |
| NCT06642909 | HS006-MN-01 | Ph 2 | active not recruiting | A Phase II Study of Zuberitamab Injection in Patients With Primary Membranous Nephropathy |
| NCT05398653 | MIL62-CT206 | Ph 1, Ph 2 | completed | A Phase Ib/ Ⅱ Clinical Study of MIL62 in Primary Membranous Nephropathy |
| NCT05579769 results posted | CNI60 | Ph 2 | terminated | Pediatric Study of GVHD Ppx w/o Calcineurin Inhibitors After Day60 Post First Allo HSCT for Hematological Malignancies. |
| NCT07196449 MRCI | MRCI | Ph 1 | active not recruiting | Drug-Drug Interaction of Rifampicin and Cyclosporine on Methotrexate Pharmacokinetics in Healthy Subjects |
| NCT05399732 | HanB-NSAA-lus | Ph 2 | completed | Efficacy and Safety in Transfusion Independent Non-severe Aplastic Anemia |
| NCT06892756 DDI2 | CLI-06001AA1-06 2024-516475-32-00 | Ph 1 | completed | Effect of Cyclosporine Drug Interaction on the Absorption, Metabolism and Elimination of CHF6001 in Healthy Volunteers. Drug-Drug Interaction 2 (DDI2) Study |
| NCT07138898 | 25-00380 | Ph 2 | not yet recruiting | Immunosuppressant Management in Rheumatology Patients Undergoing Elective Total Shoulder Arthroplasty |
| NCT05862233 | MIL62-CT307 | Ph 3 | active not recruiting | A Phase Ⅲ Clinical Study of MIL62 in Primary Membranous Nephropathy |
| NCT06541678 | C3421063 2024-513863-21-00 | Ph 1 | completed | A Study to Learn if the Study Medicines Called Itraconazole and Cyclosporine Change How the Body Processes the Other Study Medicine Called Danuglipron in Healthy Adults. |
| NCT06809608 | BP45670 2024-517360-37-00 | Ph 1 | completed | A Study Investigating the Effect of Different Approved Medications on How the Body Processes the Study Compound RO7795081 |
| NCT04530487 results posted | 2020-0496 NCI-2020-05879, 2020-0496 | Ph 2 | terminated | Donor Stem Cell Transplant After Chemotherapy for the Treatment of Recurrent or Refractory High-Risk Solid Tumors in Pediatric and Adolescent-Young Adults |
| NCT00974142 results posted | PRO09050330 | Ph 1, Ph 2 | completed | Oral Cyclosporine in Chronic Obstructive Pulmonary Disease |
| NCT03246906 results posted | 9816 NCI-2017-01311, 9816 | Ph 2 | terminated | Comparison of Triple GVHD Prophylaxis Regimens for Nonmyeloablative or Reduced Intensity Conditioning Unrelated Mobilized Blood Cell Transplantation |
| NCT04979884 | cyclosporine in COVID-19 | Ph 3 | completed | Safety and Effectiveness of Cyclosporin in the Management of COVID19 ARDS Patients in Alexandria University Hospital |
| NCT03434730 | 17-616 | Ph 2 | completed | Tocilizumab for the Prevention of Graft Versus Host Disease After Cord Blood Transplantation |
| NCT05057468 | 17300534 | Ph 3 | recruiting | Second-line Treatment of Primary Autoimmune Hemolytic Anemia |
| NCT02188264 | NCI-2014-01484 NCI-2014-01484, 13-2628 | Ph 1 | completed | Selumetinib and Cyclosporine in Treating Patients With Advanced Solid Tumors or Advanced or Metastatic Colorectal Cancer |
| NCT02416388 BIG-1 | PHRC-2010-03 | Ph 2, Ph 3 | recruiting | Study to Improve OS in 18 to 60 Year-old Patients, Comparing Daunorubicin Versus High Dose Idarubicin Induction Regimens, High Dose Versus Intermediate Dose Cytarabine Consolidation Regimens, and Standard Versus MMF Prophylaxis of GvHD in Allografted Patients in First CR |
| NCT02867800 | AAAQ2350 | Ph 1 | completed | Abatacept for GVHD Prophylaxis After Hematopoietic Stem Cell Transplantation for Pediatric Sickle Cell Disease |
| NCT06424639 | LC-001 | Ph 4 | not yet recruiting | Luspatercept Plus CsA vs CsA for the Treatment of Newly Diagnosed Non-Transfusion-Dependent NSAA |
| NCT06364319 | 2024PHD002-001 | Ph 4 | not yet recruiting | Efficacy and Safety of Anti-CD25 rhMAb in the Treatment of Steroid-Refractory cGVHD |
| NCT03013933 | 16414 NCI-2016-02062, 16414 | Ph 1 | completed | Brentuximab Vedotin, Cyclosporine, and Verapamil Hydrochloride in Treating Patients With Relapsed or Refractory Hodgkin Lymphoma |
| NCT01041508 results posted | T2008-005 IND 101588 | Ph 1 | completed | Clofarabine and Low Dose Total Body Irradiation as a Preparative Regimen for Stem Cell Transplant in Leukemia. |
| NCT04515329 | STUDY20010206 | Ph 4 | withdrawn | Tear Film Markers in Dry Eye Syndrome |
| NCT02998645 SOAR results posted | CETB115E2403 2016-002814-29 | Ph 2 | completed | Eltrombopag Combined With Cyclosporine as First Line Therapy in Patients With Severe Acquired Aplastic Anemia |
| NCT04555694 results posted | TC-2020-DexRes | Ph 4 | completed | Comparing Treatment of Dry Eye With Intracanalicular Dexamethasone, Restasis, and/or Lotemax |
| NCT00816413 | 0164-07-FB P30CA036727 | Ph 1, Ph 2 | withdrawn | Donor Stem Cell Transplant, Pentostatin, and Total-Body Irradiation in Treating Patients With Hematological Cancer |
| NCT04492891 results posted | H-48163 | Ph 2 | completed | Cyclosporine For The Treatment Of COVID-19(+) |
| NCT00896493 results posted | IRB-16213 SU-04062009-2138, 16213 | Ph 2 | completed | Ph II of Non-myeloablative Allogeneic Transplantation Using TLI & ATG In Patients w/ Cutaneous T Cell Lymphoma |
| NCT05202145 | ALXN2050-HV-110 | Ph 1 | completed | Drug-Drug Interaction (DDI) Study of ALXN2050 in Healthy Adult Participants |
| NCT04532918 results posted | D5495C00013 | Ph 1 | completed | Pharmacokinetics of Verinurad and Allopurinol in Combination With Cyclosporine and Rifampicin in Healthy Volunteers |
| NCT00796068 results posted | 2275.00 NCI-2010-00299, 2275 | Ph 2 | completed | Treosulfan, Fludarabine Phosphate, and Total-Body Irradiation in Treating Patients With Hematological Cancer Who Are Undergoing Umbilical Cord Blood Transplant |
| NCT05573230 | 18506 J2A-MC-GZGL | Ph 1 | completed | A Drug Interaction Study of Cyclosporine and LY3502970 in Healthy Participants |
| NCT02688556 Emerald results posted | OTX-101-2016-001 | Ph 3 | completed | Phase 3 Study of OTX-101 in the Treatment of Keratoconjunctivitis Sicca |
Showing 50 of 121 trials
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Completed studies with published results, ranked by significance
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Trial Timeline
Full development history with FDA approval milestones
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Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
VERKAZIA FDA Label Details
Indications & Usage
FDA Label (PDF)VERKAZIA is indicated for the treatment of Vernal Keratoconjunctivitis.
View full patent landscape →
7 OB patents · 3 families ·
111 international docs across 24 countries
VERKAZIA Patents & Exclusivity
Latest Patent: Jun 2029
Exclusivity: Jun 2028
Patents (7 active)
Exclusivity
ODE-358
Until Jun 2028
Source: FDA Orange Book
Pro Intelligence Preview
Deep insights for VERKAZIA
Revenue Insights
- • Quarterly revenue tracking
- • Historical trend analysis
Patent Timeline
- • Cliff: 2029
- • 7 active patents
Trial Analysis
- • 121 total trials
- • Stage: Declining
Competitive Landscape
- • 1 similar drugs
- • Same target/indication analysis
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment