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Clinical trials
catalyst calendar across sponsors →Studies where OPK is the lead sponsor, as filed with ClinicalTrials.gov. Completion dates are the sponsor's own projected windows and are revised as a study runs. Active studies first, then completed and stopped — newest readout first within each.
48 interventional · 1 observational · 22 with posted results
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| Study | Phase | Status | Interventions | Conditions | Enrollment | Primary completion | Readout in | Updated |
|---|---|---|---|---|---|---|---|---|
| Phase 1/2 Study of OPK-88006 in Healthy and Presumed MASH ParticipantsNCT07512427SAD - OPK-88006 maximum plasma concentration (Cmax)Randomized · Triple-masked · Treatment | Phase 1/2 | Recruiting | Drug: OPK-88006, Placebo | MASH | 30 | Dec 2027 | ≤ 499 d | 2026-07-31 |
| Pharmacokinetics, Pharmacodynamics, Safety and Tolerability Evaluation of CTAP101 Extended-release Capsules in Pediatric ParticipantsNCT07494045Apparent clearance (CL/F)Randomized · Open-label · Treatment | Phase 2 | Not yet recruiting | Drug: CTAP101 | CKD Stage 3, CKD Stage 4, Secondary Hyperparathyroidism, VDI | 40 | Oct 2027 | ≤ 438 d | 2026-03-30 |
| Phase 3 Safety and Efficacy Study of CTAP101 Extended-release Capsules in Children With Secondary HyperparathyroidismNCT05543928results2025-07-25Numbers of Subjects Who Attained Mean Decrease in Plasma iPTH of 30% From BaselineRandomized · Triple-masked · TreatmentStudy Protocol and Statistical Analysis Plan ↗ | Phase 3 | Terminatedsponsor's stated reason: FDA changed the post-marketing requirement necessitating a new study design and protocol. | Drug: CTAP101, Placebo | Chronic Kidney Disease stage3, Chronic Kidney Disease stage4, Vitamin d Deficiency, Secondary Hyperparathyroidism | 2 | 2024-06-19actual | — | 2025-07-25 |
| Long Term Follow up Study of Long-acting hGH (MOD-4023) in Growth Hormone Deficient ChildrenNCT02500316results2025-04-09Annualized Height VelocityOpen-label · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 2 | Completed | Drug: MOD-4023 | Growth Hormone Deficiency (GHD) | 48 | Nov 2023actual | — | 2025-04-09 |
| Safety and Efficacy of Rayaldee for Treating Mild to Moderate COVID-19NCT04551911results2024-05-28Concentration of Serum Total 25-hydroxyvitamin D Attained at or Above 50 ng/mL at Visit 3 (Day 14).Randomized · Quadruple-masked · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 2 | Completed | Drug: Rayaldee, Placebo | COVID-19, Coronavirus, SARS-CoV2 Infection | 171 | 2021-10-08actual | — | 2024-05-28 |
| Safety, Efficacy, PK and PD of CTAP101 (Calcifediol) ER Capsules for SHPT in HD Patients VDINCT03602261results2025-03-30Number of Participants With Response During Efficacy Assessment PeriodRandomized · Single-masked · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 2 | Terminatedsponsor's stated reason: Cohort 1 completed and cohort 2 terminated prior to initiation per company decision | Drug: Calcifediol Oral Capsule, Placebo oral capsule | Secondary Hyperparathyroidism Due to Renal Causes, Chronic Kidney Diseases, Vitamin D Deficiency, Stage 5 Chronic Kidney Disease | 44 | 2021-02-24actual | — | 2026-04-03 |
| Quality of Life and Visual Acuity of Visglyc Eye Drops on Dry Eye PatientsNCT04063644Change in quality of visual life: NEI VFQ-25 questionnaireRandomized · Single-masked · Supportive care | Not applicable | Completed | Device: Vis Glyc Neo, Physiological saline solution | Dry Eye Syndromes, Cataract | 100 | 2020-12-22actual | — | 2021-03-23 |
| Efficacy and Safety of a Intra-articular Injection, ENKO1, in Patients With Symptomatic Knee Osteoarthritis.NCT03762408Pain ReliefRandomized · Single-masked · Treatment | Not applicable | Completed | Device: ENKO 1, Durolane | Osteoarthritis, Knee | 175 | 2020-05-29actual | — | 2021-03-23 |
| Repeated-dose Safety, Efficacy, Pharmacokinetic and Pharmacodynamic of CTAP101, Immediate-release Calcifediol, High-dose Cholecalciferol, and Paricalcitol Plus Low-dose Cholecalciferol in Patients With Secondary Hyperparathyroidism, Chronic Kidney Disease 3-4 and Vitamin D InsufficiencyNCT03588884results2022-12-09Incidence and Severity of Treatment-Emergent Adverse Events (TEAE) as Assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0.Randomized · Open-label · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 4 | Completed | Drug: Calcifediol Oral Capsule, Calcifediol Oral Product, Cholecalciferol, Paricalcitol Oral Capsule | Secondary Hyperparathyroidism Due to Renal Causes, Vitamin D Insufficiency, CKD Stage 3, CKD Stage 4 | 69 | 2020-04-24actual | — | 2022-12-09 |
| Safety and Efficacy Study of MOD-4023 to Treat Children With Growth Hormone DeficiencyNCT03874013results2021-08-12Annual Height Velocity (HV) After 12 MonthsRandomized · Single-masked · OtherStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 3 | Completed | Drug: MOD-4023, Genotropin | Growth Hormone Deficiency | 44 | 2020-03-06actual | — | 2021-08-12 |
| Safety and Efficacy Phase 3 Study of Long-acting hGH (MOD-4023) in Growth Hormone Deficient ChildrenNCT02968004results2021-06-25Annual Height Velocity in Main Study PhaseRandomized · Open-label · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 3 | Completed | Drug: MOD-4023, Somatropin | Pediatric Growth Hormone Deficiency | 224 | Aug 2019actual | — | 2025-07-20 |
| A Clinical Study Investigating the Comparability of Somatrogon in Two Different Drug Product PresentationsNCT03810664Area under the curve (AUC) of the serum concentration-time from time 0 to a specific time (AUCt)Randomized · Open-label · Other | Phase 1 | Completed | Drug: Somatrogon | Healthy Male Volunteers | 49 | 2019-04-19actual | — | 2020-04-28 |
| Effects and Safety of OPK-88004 Doses in Men With Signs and Symptoms of Benign Prostatic Hyperplasia (BPH)NCT03297398results2021-07-28Change From Baseline in PSA (%) to Week 16Randomized · Triple-masked · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 2 | Terminatedsponsor's stated reason: study terminated by sponsor decision | Drug: Group-1 (15mg, OPK-88004), Group-2 (25 mg,OPK-88004) · Other: Placebo | Benign Prostatic Hyperplasia | 114 | 2019-04-18actual | — | 2021-09-16 |
| Effects and Safety of OPK-88003 Dose Escalation in Type 2 Diabetes SubjectsNCT03406377results2021-06-15Change in HbA1c in Subjects With Type 2 DMRandomized · Triple-masked · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 2 | Completed | Drug: OPK-88003, Placebo | Type 2 Diabetes Mellitus | 113 | 2019-03-08actual | — | 2021-06-15 |
| Pharmacokinetics and Safety Study of CTAP101 Capsules in Japanese and Non-Japanese Healthy Subjects and Non-Japanese Healthy SubjectsNCT03660800Number of participants with treatment-related AEs as assessed by industry standardsRandomized · Open-label · Basic science | Phase 1 | Completed | Drug: CTAP101 Capsules | Vitamin D Insufficiency, Secondary Hyperparathyroidism | 67 | 2018-10-24actual | — | 2019-09-30 |
| A Study of a Long-Acting r-Factor 7a (Factor VIIa) in Adult Men With Hemophilia A or BNCT02418793Composite safety and tolerability parameters as measured by adverse events, electrocardiograms (ECG), laboratory results, vital signs and injection site reactionsNon-randomized · Open-label · Treatment | Phase 1 | Completed | Drug: MOD-5014 | Hemophilia A, Hemophilia B | 27 | Sep 2018actual | — | 2021-05-20 |
| 4Kscore Using Serum Stored UncentrifugedNCT04130776observationaltPSA changes in 3 days | — | Completed | Diagnostic test: Measurement of four prostate-specific kallikreins for the 4Kscore Test when serum stored uncentrifuged | Prostate Cancer | 64 | 2018-03-27actual | — | 2019-10-17 |
| A Single-dose, Dose-escalation Study of a Long-acting MOD-5014 in Healthy Adult MaleNCT02919800Composite safety and tolerability parameters as measured by adverse events, electrocardiograms (ECG), Immunogenicity, laboratory results, vital signs and injection site reactionsRandomized · Single-masked · Other | Phase 1 | Completed | Biological: MOD-5014 · Other: MOD-5014 Placebo | Hemophilia A or B With Inhibitors | 32 | 2018-02-21actual | — | 2019-09-30 |
| Effect of CTAP101 Capsules on Ca/iPTH in Advanced Breast/Prostate Cancer Patients Treated With Denosumab/Zoledronic AcidNCT02274623Effect of repeated, escalating doses of CTAP101 on serum calcium and plasma iPTH levelsOpen-label · Supportive care | Phase 1 | Completed | Drug: CTAP101 Capsules | Breast Cancer, Prostate Cancer, Bone Neoplasms, Hypocalcemia, Hyperparathyroidism, Secondary | 33 | 2017-02-27actual | — | 2019-09-27 |
| Efficacy and Tolerability of a Nutritional Supplement, Plactive Progen, in ACL ReconstructionNCT03355651Pain improvementRandomized · Single-masked · Treatment | Not applicable | Completed | Dietary supplement: PROGEN | ACL Reconstruction | 80 | 2017-02-01actual | — | 2017-11-30 |
| A Single-dose, Dose-escalation Study of a Long-acting MOD-6031 in Healthy Overweight or Obese SubjectsNCT02692781Composite safety and tolerability parameters as measured by adverse events, electrocardiograms (ECG), laboratory results, vital signs and injection site reactionsRandomized · Single-masked · Treatment | Phase 1 | Completed | Drug: MOD-6031 · Other: Placebo control | Obesity | 32 | 2016-12-15actual | — | 2019-09-30 |
| A Phase 3, Multicenter Study To Evaluate The Efficacy And Safety Of MOD-4023 In Adults With Growth Hormone DeficiencyNCT01909479results2022-08-12Change in Trunk Fat Mass, Expressed in Kilograms Measured With Dual-energy X-ray Absorptiometry, From Baseline to Week 26Randomized · Quadruple-masked · Treatment | Phase 3 | Terminatedsponsor's stated reason: Main Study was completed. LT-OLE was discontinued as sufficient safety data has been generated. | Drug: MOD-4023 · Other: Placebo | Adult Growth Hormone Deficiency | 202 | Aug 2016actual | — | 2022-08-12 |
| A 36-Week Safety Extension Study of ELND005 as a Treatment for Agitation and Aggression in Alzheimer's DiseaseNCT01766336results2016-05-13Number of Participants Experiencing Treatment Emergent Adverse EventsRandomized · Quadruple-masked · Treatment | Phase 2 | Terminated | Drug: Group 1 ELND005, Group 2 ELND005 | Alzheimer's Disease | 296 | Aug 2015actual | — | 2019-10-21 |
| A Study to Compare a New Drug for Type 2 Diabetes to Placebo and to a Treatment Already Available for Type 2 DiabetesNCT02119819results2021-04-14Change From Baseline in Hemoglobin A1c (HbA1c) at Week 12Randomized · Double-masked · Treatment | Phase 2 | Completed | Drug: LY2944876, Exenatide extended-release, Placebo, Metformin | Diabetes Mellitus, Type 2 | 420 | Aug 2015actual | — | 2021-05-27 |
| Safety and Efficacy Phase 2 Study of Long-acting hGH (MOD-4023) in Growth Hormone Deficient ChildrenNCT01592500results2020-01-23Annual Height VelocityRandomized · Open-label · Treatment | Phase 2 | Completed | Drug: MOD-4023, Somatropin | Pediatric Growth Hormone Deficiency | 56 | Jul 2015actual | — | 2020-01-23 |
| Efficacy and Safety Study of ELND005 as a Treatment for Agitation and Aggression in Alzheimer's DiseaseNCT01735630results2016-08-15Change From Baseline in NPI-C Combined Agitation and Aggression Subscores (NPI-C A+A).Randomized · Quadruple-masked · Treatment | Phase 2 | Completed | Drug: ELND005, Placebo | Alzheimer's Disease | 350 | May 2015actual | — | 2019-10-21 |
| Extension Study of CTAP101-CL-3001 or CTAP101-CL-3002NCT02282813results2016-08-17Number of Participants in the Intent to Treat Population With a Mean Reduction in Plasma Intact Parathyroid Hormone (iPTH) of >/= 30% From Baseline Values at End of Treatment (EOT)Randomized · Open-label · Treatment | Phase 3 | Completed | Drug: CTAP101 Capsules, Calcitriol, Doxercalciferol, Paricalcitol | Chronic Kidney Disease, Hyperparathyroidism, Secondary, Vitamin D Deficiency | 298 | May 2015actual | — | 2016-09-29 |
| Pharmacokinetics and Pharmacodynamics of Long Acting Human Growth Hormone (hGH) Product (MOD-4023) in Healthy Caucasian and Japanese VolunteersNCT02418767Composite safety and tolerability parameters as measured by adverse events, electrocardiograms (ECG), laboratory results, vital signs and injection site reactionsRandomized · Quadruple-masked · Other | Phase 1 | Completed | Drug: MOD-4023, Placebo | Growth Hormone Deficiency | 42 | Mar 2015actual | — | 2019-09-30 |
| A Study of LY2944876 in Healthy Japanese and Non-Japanese ParticipantsNCT02188303results2021-04-14Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to Be Related to Study Drug AdministrationRandomized · Double-masked · Basic science | Phase 1 | Terminatedsponsor's stated reason: The termination criteria of the protocol was met during dose escalation. | Drug: LY2944876, Placebo | Healthy Volunteers | 48 | Dec 2014actual | — | 2021-05-27 |
| Safety and Efficacy Study of ELND005 as an Adjunctive Maintenance Treatment in Bipolar I DisorderNCT01674010results2015-10-12Treatment Emergent Adverse EventsRandomized · Quadruple-masked · Treatment | Phase 2 | Terminatedsponsor's stated reason: Business Decision | Drug: ELND005, Lamotrigine, Valproic acid, Placebo | Bipolar 1 Disorder | 309 | Jun 2014actual | — | 2019-10-21 |
| A 4-Week Safety Study of Oral ELND005 in Young Adults With Down Syndrome Without DementiaNCT01791725results2016-01-29Incidence of Adverse Events (TEAEs)Randomized · Triple-masked · Treatment | Phase 2 | Completed | Drug: ELND005, Placebo | Down Syndrome | 23 | Jun 2014actual | — | 2019-11-04 |
| Four Week, Pharmacodynamic/Pharmacokinetic, Efficacy, and Safety Study of Lunacalcipol (CTA018)NCT01453634Measure the intact parathyroid hormone (iPTH) levels following Lunacalcipol InjectionRandomized · Quadruple-masked · Treatment | Phase 2 | Withdrawnsponsor's stated reason: The company is no longer pursuing this study. | Drug: Lunacalcipol 180, Lunicalcipol 270 | Stage 5 Chronic Kidney Disease (CKD), Secondary Hyperparathyroidism (SHPT), Hemodialysis (HD) | 0 | Jul 2013 | — | 2014-09-22 |
| Safety/Efficacy Study of CTAP101 in Chronic Kidney Disease Subjects With Secondary Hyperparathyroidism (SHPT)NCT01219855results2016-08-25Proportion (%) of Subjects With Serum 25-hydroxyvitamin D ≥30 ng/mL (PP).Randomized · Triple-masked · Treatment | Phase 2/3 | Completed | Drug: Cohort 1 CTAP101 Capsules- 60µg, Cohort 1 CTAP101 Capsules - 90µg, Cohort 1 Matching Sugar Capsule, Cohort 2 CTAP101 Capsules - 30µg, Cohort 2 Matching Sugar Capsule | Chronic Kidney Disease, Secondary Hyperparathyroidism, Vitamin D Insufficiency | 78 | Nov 2011actual | — | 2016-08-25 |
| Safety & Efficacy Study Evaluating the Combination of Bevasiranib & Lucentis Therapy in Wet AMD (CARBON)NCT00557791Primary efficacy measure: The proportion of patients at week 60 in each group with a successful visual acuity outcome (as defined as avoidance of a 3, or more, line loss in vision).Randomized · Quadruple-masked · Treatment | Phase 3 | Withdrawnsponsor's stated reason: Study never initiated | Drug: Bevasiranib, ranibizumab | Age Related Macular Degeneration | 0 | Jul 2011 | — | 2015-03-06 |
| MOD-4023 (Long-Lasting Human Growth Hormone (hGH)) Study in Growth Hormone Deficient Adults (GHDA)NCT012256661. Safety and TolerabilityRandomized · Open-label · Treatment | Phase 2 | Completed | Drug: MOD-4023, MOD-4023, MOD-4023, MOD-4023 | Adult Growth Hormone Deficiency | 52 | Jul 2011actual | — | 2019-10-08 |
| ELND005 Long-Term Follow-up Study in Subjects With Alzheimer's DiseaseNCT00934050results2015-05-13Treatment Emergent Adverse Events (TEAEs)Open-label · Treatment | Phase 2 | Completed | Drug: ELND005 (scyllo-inositol) | Alzheimer's Disease | 103 | Jun 2011actual | — | 2019-10-21 |
| Effects of TT301 on Cytokine Levels Post Endotoxin ChallengeNCT01357421Cytokine levels post LPS challengeRandomized · Quadruple-masked · Treatment | Phase 1 | Completed | Drug: TT301, Placebo | Traumatic Brain Injury | 18 | Jun 2011actual | — | 2013-06-06 |
| ELND005 in Patients With Mild to Moderate Alzheimer's DiseaseNCT00568776results2012-03-29Change From Baseline to Week 78 in Neuropsychological Test Battery (NTB) Z-score (Full Analysis Set; FAS)Randomized · Quadruple-masked · Treatment | Phase 2 | Completed | Drug: Placebo Control, ELND005, ELND005, ELND005 | Alzheimer Disease | 353 | May 2010actual | — | 2019-11-01 |
| MOD-4023 Study in Healthy Male VolunteersNCT01060722Safety and Tolerability (AE's, vital signs, ECG, laboratory tests, local reaction)Randomized · Triple-masked · Treatment | Phase 1 | Completed | Drug: MOD-4023 (long lasting hGH), Placebo | Healthy | 24 | Jan 2010actual | — | 2019-09-30 |
| A Trial of TT223 in Patients With Type 2 Diabetes Who Are Taking Metformin and/or ThiazolidinedioneNCT00743002To evaluate the safety and tolerability of TT223 as a treatment for Type 2 diabetes at 1 mg, 2 mg and 3 mg.Randomized · Triple-masked · Treatment | Phase 2 | Completed | Drug: TT223 with Metformin and/or TZD, Placebo with Metformin and/or TZD | Diabetes Mellitus, Type 2 | 87 | Dec 2009actual | — | 2013-06-21 |
| A Prospective, Multicenter, Open-label, Safety and Preliminary Efficacy Study of the Surgical Implantation of OPKO's Glaucoma Drainage Device (AquashuntTM) in Patients With Refractory Chronic Forms of Open Angle Glaucoma (OAG)NCT00834223Primary efficacy measure: The percentage change in IOP from baseline to 6 months and 12 months post-implantation.Non-randomized · Open-label · Treatment | Not applicable | Completed | Device: Aquashunt | Glaucoma | 15 | Sep 2009actual | — | 2011-04-01 |
| Safety & Efficacy Study Evaluating the Combination of Bevasiranib & Lucentis Therapy in Wet AMDNCT00499590results2014-10-06Visual AcuityRandomized · Quadruple-masked · Treatment | Phase 3 | Terminated | Drug: bevasiranib, ranibizumab | Macular Degeneration | 338 | Mar 2009actual | — | 2014-10-06 |
| Safety and Efficacy Study of Small Interfering Ribonucleic Acid (RNA) Molecule (Cand5) to Treat Wet Age-Related Macular DegenerationNCT00259753change from baseline at the 12-week evaluation in macular edema as measured by optical coherence tomography.Randomized · Quadruple-masked · Treatment | Phase 2 | Completed | Drug: Bevasiranib | Macular Degeneration | 120 | Dec 2007actual | — | 2008-08-05 |
| Safety and Efficacy Study of Small Interfering RNA Molecule (Cand5) to Treat Diabetic Macular EdemaNCT00306904Change from baseline at the 12-week evaluation in macular edema as measured by optical coherence tomography.Randomized · Quadruple-masked · Treatment | Phase 2 | Completed | Drug: bevasiranib | Diabetic Macular Edema | 48 | Sep 2007actual | — | 2008-07-25 |
| Open Label Study for the Evaluation of Tolerability of Five Dose Levels of Cand5NCT00722384Complications, including those related to the intravitreal injection, and adverse events, and loss of lines of best-corrected visual acuity, slit lamp findings, lens opacification, intraocular pressure, fundus findings, and laboratory findings.Non-randomized · Open-label · Treatment | Phase 1 | Completed | Drug: bevasiranib, bevasiranib | Macular Degeneration | 15 | Aug 2007actual | — | 2008-07-25 |
| Safety and Efficacy of Topically Applied CTA018 in Plaque PsoriasisNCT00384098The primary endpoint will be treatment success or failure based on a Physician's Static Global Assessment (PSGA) of 0 or 1 (success).Randomized · Double-masked · Treatment | Phase 2 | Completed | Drug: CTA018 cream | Psoriasis | 140 | May 2007actual | — | 2014-09-29 |
| Study in Non-responder Hepatitis C Genotype 1 Patients With EMZ702, Pegylated Interferon and RibavirinNCT00230854To evaluate the safety and tolerability of repeated intravenous infusions of EMZ702 in combination with pegylated interferon and ribavirin in patients with chronic hepatitis C genotype 1Non-randomized · Open-label · Treatment | Phase 1 | Completed | Drug: EMZ702 | Chronic Hepatitis C, Hepatitis, Viral, Human | 28 | — | — | 2019-10-18 |
| A Study in Type 1 Diabetic Patients With Repeated Doses of E1 in Combination With G1NCT00239148To evaluate the safety and tolerability of repeated subcutaneous doses of E1 in combination with G1 in patients with type 1 diabetesRandomized · Double-masked · Treatment | Phase 1 | Completed | Drug: E1 and G1 | Type 1 Diabetes | 20 | — | — | 2019-10-18 |
| A Study in Type 2 Diabetic Patients With Repeated Doses of E1 in Combination With G1NCT00239187To assess the safety and tolerability of repeated subcutaneous doses of E1 in combination with G1 in patients with type 2 diabetesRandomized · Double-masked · Treatment | Phase 1 | Completed | Drug: E1 and G1 | Type 2 Diabetes | 30 | — | — | 2019-10-18 |
Primary completion is the date the sponsor filed with the registry — their own projection, revised whenever they revise it, unless the row is marked actual.
Source: ClinicalTrials.gov, retrieved 2026-08-19