COMPANY

Opko Health

HQ: Miami, FL source · opko.com ↗ · Southeast

FDA-cleared device company Clinical Phase 3

Keywords: lipid nanoparticles nanoparticles protein engineering Secondary Hyperparathyroidism Vitamin D Deficiency Vitamin D Insufficiency Type 2 Diabetes Mellitus Alzheimer's Disease Macular Degeneration Secondary Hyperparathyroidism Due to Renal Causes Pediatric Growth Hormone Deficiency Adult Growth Hormone Deficiency Growth Hormone Deficiency Prostate Cancer Chronic Kidney Disease MASH Chronic Kidney Diseases Chronic Kidney Disease stage3 Chronic Kidney Disease stage4 COVID-19 Coronavirus SARS-CoV2 Infection Benign Prostatic Hyperplasia Hemophilia A Hemophilia B Dry Eye Syndromes Cataract Knee Osteoarthritis Down Syndrome Alzheimer Disease Bipolar 1 Disorder Chronic Hepatitis C Hepatitis, Viral, Human Type 1 Diabetes Type 2 Diabetes Hemophilia A or B With Inhibitors Obesity

Location: Miami, FL · source · Oct 15, 2026

Profile checked Oct 10, 2026

49Trials (company is sponsor)

Timeline

Aug 5, 2026 Trial start Phase 2: Pharmacokinetics, Pharmacodynamics, Safety and Tolerability Evaluation of CTAP101 Extended-release Capsules in Pediatric Participants source ↗
Jul 24, 2026 Trial start 1: Phase 1/2 Study of OPK-88006 in Healthy and Presumed MASH Participants source ↗
Jan 31, 2023 Trial start 3: Phase 3 Safety and Efficacy Study of CTAP101 Extended-release Capsules in Children With Secondary Hyperparathyroidism source ↗
Nov 2, 2020 Trial start Phase 2: Safety and Efficacy of Rayaldee for Treating Mild to Moderate COVID-19 source ↗
May 30, 2019 Trial start Not phased (device or behavioral study): Quality of Life and Visual Acuity of Visglyc Eye Drops on Dry Eye Patients source ↗
Jan 18, 2019 Trial start Phase 1: A Clinical Study Investigating the Comparability of Somatrogon in Two Different Drug Product Presentations source ↗
Aug 20, 2018 Trial start Phase 1: Pharmacokinetics and Safety Study of CTAP101 Capsules in Japanese and Non-Japanese Healthy Subjects and Non-Japanese Healthy Subjects source ↗
Jul 9, 2018 Trial start Phase 2: Safety, Efficacy, PK and PD of CTAP101 (Calcifediol) ER Capsules for SHPT in HD Patients VDI source ↗
Jun 8, 2018 Trial start Phase 4: Repeated-dose Safety, Efficacy, Pharmacokinetic and Pharmacodynamic of CTAP101, Immediate-release Calcifediol, High-dose Cholecalciferol, and Paricalcitol Plus Low-dose Cholecalciferol in Pat source ↗
Apr 2, 2018 Trial start Phase 2: Effects and Safety of OPK-88003 Dose Escalation in Type 2 Diabetes Subjects source ↗
Feb 21, 2018 Trial start Phase 2: Effects and Safety of OPK-88004 Doses in Men With Signs and Symptoms of Benign Prostatic Hyperplasia (BPH) source ↗
Dec 15, 2017 Trial start Not phased (device or behavioral study): Efficacy and Safety of a Intra-articular Injection, ENKO1, in Patients With Symptomatic Knee Osteoarthritis. source ↗
Dec 7, 2017 Trial start Phase 3: Safety and Efficacy Study of MOD-4023 to Treat Children With Growth Hormone Deficiency source ↗
Oct 4, 2017 Trial start —: 4Kscore Using Serum Stored Uncentrifuged source ↗
Jan 22, 2017 Trial start Phase 1: A Single-dose, Dose-escalation Study of a Long-acting MOD-5014 in Healthy Adult Male source ↗
2016-12 Trial start 3: Safety and Efficacy Phase 3 Study of Long-acting hGH (MOD-4023) in Growth Hormone Deficient Children source ↗
2016-02 Trial start Phase 1: A Single-dose, Dose-escalation Study of a Long-acting MOD-6031 in Healthy Overweight or Obese Subjects source ↗
2015-05 Trial start Phase 1: A Study of a Long-Acting r-Factor 7a (Factor VIIa) in Adult Men With Hemophilia A or B source ↗
Mar 9, 2015 Trial start Not phased (device or behavioral study): Efficacy and Tolerability of a Nutritional Supplement, Plactive Progen, in ACL Reconstruction source ↗
2015-01 Trial start Phase 1: Pharmacokinetics and Pharmacodynamics of Long Acting Human Growth Hormone (hGH) Product (MOD-4023) in Healthy Caucasian and Japanese Volunteers source ↗
2014-12 Trial start Phase 1: Effect of CTAP101 Capsules on Ca/iPTH in Advanced Breast/Prostate Cancer Patients Treated With Denosumab/Zoledronic Acid source ↗
2014-07 Trial start Phase 1: A Study of LY2944876 in Healthy Japanese and Non-Japanese Participants source ↗
2014-04 Trial start Phase 2: A Study to Compare a New Drug for Type 2 Diabetes to Placebo and to a Treatment Already Available for Type 2 Diabetes source ↗
2014-02 Trial start Phase 2: Long Term Follow up Study of Long-acting hGH (MOD-4023) in Growth Hormone Deficient Children source ↗
2013-09 Trial start Phase 2: A 4-Week Safety Study of Oral ELND005 in Young Adults With Down Syndrome Without Dementia source ↗

Showing 25 of 49 dated events.

Upcoming milestones

2027-10 (ESTIMATED) · Phase 2 · Pharmacokinetics, Pharmacodynamics, Safety and Tolerability Evaluation of CTAP101 Extended-release Capsules in Pediatric Participants · NCT07494045
2027-12 (ESTIMATED) · 1 · Phase 1/2 Study of OPK-88006 in Healthy and Presumed MASH Participants · NCT07512427

Estimated primary completion per ClinicalTrials.gov. Dates move.

Clinical trials (lead sponsor) 49

Record	Title	Phase	Status	Start	Primary completion
NCT07512427	Phase 1/2 Study of OPK-88006 in Healthy and Presumed MASH Participants	1	Recruiting	Jul 24, 2026	2027-12 (estimated)
NCT07494045	Pharmacokinetics, Pharmacodynamics, Safety and Tolerability Evaluation of CTAP101 Extended-release Capsules in Pediatric Participants	Phase 2	Recruiting	Aug 5, 2026	2027-10 (estimated)
NCT03602261	Safety, Efficacy, PK and PD of CTAP101 (Calcifediol) ER Capsules for SHPT in HD Patients VDI	Phase 2	Terminated	Jul 9, 2018	Feb 24, 2021 (actual)
NCT05543928	Phase 3 Safety and Efficacy Study of CTAP101 Extended-release Capsules in Children With Secondary Hyperparathyroidism	3	Terminated	Jan 31, 2023	Jun 19, 2024 (actual)
NCT02968004	Safety and Efficacy Phase 3 Study of Long-acting hGH (MOD-4023) in Growth Hormone Deficient Children	3	Completed	2016-12	2019-08 (actual)
NCT02500316	Long Term Follow up Study of Long-acting hGH (MOD-4023) in Growth Hormone Deficient Children	Phase 2	Completed	2014-02	2023-11 (actual)
NCT04551911	Safety and Efficacy of Rayaldee for Treating Mild to Moderate COVID-19	Phase 2	Completed	Nov 2, 2020	Oct 8, 2021 (actual)
NCT03588884	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 Insufficiency	Phase 4	Completed	Jun 8, 2018	Apr 24, 2020 (actual)
NCT01909479	A Phase 3, Multicenter Study To Evaluate The Efficacy And Safety Of MOD-4023 In Adults With Growth Hormone Deficiency	3	Terminated	2013-06	2016-08 (actual)
NCT03297398	Effects and Safety of OPK-88004 Doses in Men With Signs and Symptoms of Benign Prostatic Hyperplasia (BPH)	Phase 2	Terminated	Feb 21, 2018	Apr 18, 2019 (actual)
NCT03874013	Safety and Efficacy Study of MOD-4023 to Treat Children With Growth Hormone Deficiency	Phase 3	Completed	Dec 7, 2017	Mar 6, 2020 (actual)
NCT03406377	Effects and Safety of OPK-88003 Dose Escalation in Type 2 Diabetes Subjects	Phase 2	Completed	Apr 2, 2018	Mar 8, 2019 (actual)
NCT02119819	A Study to Compare a New Drug for Type 2 Diabetes to Placebo and to a Treatment Already Available for Type 2 Diabetes	Phase 2	Completed	2014-04	2015-08 (actual)
NCT02188303	A Study of LY2944876 in Healthy Japanese and Non-Japanese Participants	Phase 1	Terminated	2014-07	2014-12 (actual)
NCT02418793	A Study of a Long-Acting r-Factor 7a (Factor VIIa) in Adult Men With Hemophilia A or B	Phase 1	Completed	2015-05	2018-09 (actual)
NCT04063644	Quality of Life and Visual Acuity of Visglyc Eye Drops on Dry Eye Patients	Not phased (device or behavioral study)	Completed	May 30, 2019	Dec 22, 2020 (actual)
NCT03762408	Efficacy and Safety of a Intra-articular Injection, ENKO1, in Patients With Symptomatic Knee Osteoarthritis.	Not phased (device or behavioral study)	Completed	Dec 15, 2017	May 29, 2020 (actual)
NCT03810664	A Clinical Study Investigating the Comparability of Somatrogon in Two Different Drug Product Presentations	Phase 1	Completed	Jan 18, 2019	Apr 19, 2019 (actual)
NCT01592500	Safety and Efficacy Phase 2 Study of Long-acting hGH (MOD-4023) in Growth Hormone Deficient Children	2	Completed	2012-02	2015-07 (actual)
NCT01791725	A 4-Week Safety Study of Oral ELND005 in Young Adults With Down Syndrome Without Dementia	Phase 2	Completed	2013-09	2014-06 (actual)
NCT00568776	ELND005 in Patients With Mild to Moderate Alzheimer's Disease	Phase 2	Completed	2007-12	2010-05 (actual)
NCT01735630	Efficacy and Safety Study of ELND005 as a Treatment for Agitation and Aggression in Alzheimer's Disease	Phase 2	Completed	2012-11	2015-05 (actual)
NCT01766336	A 36-Week Safety Extension Study of ELND005 as a Treatment for Agitation and Aggression in Alzheimer's Disease	Phase 2	Terminated	2013-01	2015-08 (actual)
NCT01674010	Safety and Efficacy Study of ELND005 as an Adjunctive Maintenance Treatment in Bipolar I Disorder	Phase 2	Terminated	2012-08	2014-06 (actual)
NCT00934050	ELND005 Long-Term Follow-up Study in Subjects With Alzheimer's Disease	Phase 2	Completed	2009-06	2011-06 (actual)
NCT00230854	Study in Non-responder Hepatitis C Genotype 1 Patients With EMZ702, Pegylated Interferon and Ribavirin	Phase 1	Completed	2005-08	Not listed
NCT00239148	A Study in Type 1 Diabetic Patients With Repeated Doses of E1 in Combination With G1	Phase 1	Completed	2005-06	Not listed
NCT00239187	A Study in Type 2 Diabetic Patients With Repeated Doses of E1 in Combination With G1	Phase 1	Completed	2005-09	Not listed
NCT04130776	4Kscore Using Serum Stored Uncentrifuged	Not listed	Completed	Oct 4, 2017	Mar 27, 2018 (actual)
NCT01225666	MOD-4023 (Long-Lasting Human Growth Hormone (hGH)) Study in Growth Hormone Deficient Adults (GHDA)	Phase 2	Completed	2010-08	2011-07 (actual)
NCT02418767	Pharmacokinetics and Pharmacodynamics of Long Acting Human Growth Hormone (hGH) Product (MOD-4023) in Healthy Caucasian and Japanese Volunteers	Phase 1	Completed	2015-01	2015-03 (actual)
NCT03660800	Pharmacokinetics and Safety Study of CTAP101 Capsules in Japanese and Non-Japanese Healthy Subjects and Non-Japanese Healthy Subjects	Phase 1	Completed	Aug 20, 2018	Oct 24, 2018 (actual)
NCT01060722	MOD-4023 Study in Healthy Male Volunteers	Phase 1	Completed	2009-10	2010-01 (actual)
NCT02919800	A Single-dose, Dose-escalation Study of a Long-acting MOD-5014 in Healthy Adult Male	Phase 1	Completed	Jan 22, 2017	Feb 21, 2018 (actual)
NCT02692781	A Single-dose, Dose-escalation Study of a Long-acting MOD-6031 in Healthy Overweight or Obese Subjects	Phase 1	Completed	2016-02	Dec 15, 2016 (actual)
NCT02274623	Effect of CTAP101 Capsules on Ca/iPTH in Advanced Breast/Prostate Cancer Patients Treated With Denosumab/Zoledronic Acid	Phase 1	Completed	2014-12	Feb 27, 2017 (actual)
NCT03355651	Efficacy and Tolerability of a Nutritional Supplement, Plactive Progen, in ACL Reconstruction	Not phased (device or behavioral study)	Completed	Mar 9, 2015	Feb 1, 2017 (actual)
NCT02282813	Extension Study of CTAP101-CL-3001 or CTAP101-CL-3002	Phase 3	Completed	2013-04	2015-05 (actual)
NCT01219855	Safety/Efficacy Study of CTAP101 in Chronic Kidney Disease Subjects With Secondary Hyperparathyroidism (SHPT)	Phase 2/Phase 3	Completed	2010-10	2011-11 (actual)
NCT00557791	Safety & Efficacy Study Evaluating the Combination of Bevasiranib & Lucentis Therapy in Wet AMD (CARBON)	Phase 3	Withdrawn	2009-11	2011-07 (estimated)
NCT00499590	Safety & Efficacy Study Evaluating the Combination of Bevasiranib & Lucentis Therapy in Wet AMD	Phase 3	Terminated	2007-08	2009-03 (actual)
NCT00384098	Safety and Efficacy of Topically Applied CTA018 in Plaque Psoriasis	Phase 2	Completed	2006-09	2007-05 (actual)
NCT01453634	Four Week, Pharmacodynamic/Pharmacokinetic, Efficacy, and Safety Study of Lunacalcipol (CTA018)	Phase 2	Withdrawn	2013-01	2013-07 (estimated)
NCT00743002	A Trial of TT223 in Patients With Type 2 Diabetes Who Are Taking Metformin and/or Thiazolidinedione	Phase 2	Completed	2008-08	2009-12 (actual)
NCT01357421	Effects of TT301 on Cytokine Levels Post Endotoxin Challenge	Phase 1	Completed	2011-05	2011-06 (actual)
NCT00834223	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)	Not phased (device or behavioral study)	Completed	2009-01	2009-09 (actual)
NCT00259753	Safety and Efficacy Study of Small Interfering Ribonucleic Acid (RNA) Molecule (Cand5) to Treat Wet Age-Related Macular Degeneration	Phase 2	Completed	2005-07	2007-12 (actual)
NCT00306904	Safety and Efficacy Study of Small Interfering RNA Molecule (Cand5) to Treat Diabetic Macular Edema	Phase 2	Completed	2006-01	2007-09 (actual)
NCT00722384	Open Label Study for the Evaluation of Tolerability of Five Dose Levels of Cand5	Phase 1	Completed	2004-08	2007-08 (actual)