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OPKO HEALTH, INC. (OPK)

OPKO Health, Inc. operates as a healthcare enterprise with a dual focus on diagnostics and pharmaceuticals. Its operations span the United States, Ireland, Chile, Spain, Israel, Mexico, and other international markets. The company's Diagnostics division encompasses BioReference Laboratories, which delivers a comprehensive suite of laboratory testing services. These services are crucial for disease detection, diagnosis, evaluation, monitoring, and treatment, covering areas such as esoteric testing, molecular diagnostics, anatomical pathology, genetics, women's health, and correctional healthcare. BioReference serves a diverse client base, including medical practices, clinics, hospitals, employers, and government entities. Additionally, this segment provides a cutting-edge diagnostic instrument system designed for immediate, point-of-care blood test results, alongside its specialized 4Kscore testing for prostate cancer. Within the Pharmaceutical segment, OPKO offers a range of therapeutic products and a robust development pipeline. Key offerings include Rayaldee, indicated for the management of secondary hyperparathyroidism in adults suffering from stage 3 or 4 chronic kidney disease and vitamin D insufficiency. The pipeline features OPK88004, an investigational orally administered selective androgen receptor modulator; OPK88003, a peptide administered once weekly currently in Phase IIb trials for the treatment of type 2 diabetes and obesity; and hGH-CTP, a once-weekly human growth hormone injection that has successfully completed Phase III clinical trials in collaboration with Pfizer, Inc. A core strategy for this segment involves the development and commercialization of proprietary, extended-release versions of existing therapeutic proteins. Furthermore, OPKO Health supplies specialty active pharmaceutical ingredients (APIs) and is involved in the development, manufacturing, marketing, and sale of pharmaceutical, nutraceutical, veterinary, and ophthalmic products. The company also commercializes food supplements and over-the-counter products, produces and sells items primarily within the generics market, and handles the import, marketing, distribution, and sales of pharmaceutical products across various therapeutic areas, including cardiovascular conditions, vaccines, antibiotics, gastro-intestinal ailments, and hormone-related treatments, among others. Its pharmaceutical operations are further bolstered by platforms situated in Ireland, Chile, Spain, and Mexico. Founded in 1991, OPKO Health, Inc. maintains its corporate headquarters in Miami, Florida.

Sector: Pharmaceutical Preparations

Industry: Medical - Diagnostics & Research

OPKO Health, Inc. logo

OPKO Health, Inc.

NASDAQ:OPKHealthcare
+0.00%$1.66
AH$1.64-1.14%vs close
Mkt Cap$1.24B
Float365.03M
O/S746.33M
Vol
$ Vol
RVOL
Inst Own27.2%
SI9.3%
Earnings
Dilution
OPKO Health, Inc. logoNASDAQ:OPK$1.66+0.00%
Phase Distribution
53 lead-sponsored trials·6 active·37 completed
Phase 115
Phase 1/24
Phase 220
Phase 2/31
Phase 37
Phase 41
Not applicable5
(2 more as collaborator)
Status Overview
Recruiting6
Completed37
Stopped10

Trials need funding. See this company's dilution risk and cash position.

Clinical Trials
Sponsor role
Status
Phase
  • Phase 4
    Completed

    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

    Calcifediol Oral Capsule, Calcifediol Oral Product

    Secondary Hyperparathyroidism Due to Renal Causes, Vitamin D Insufficiency +2

    Enrollment
    69
    Start
    Jun 2018
    Primary Completion
    Apr 2020
    Completion
    Apr 2020
    NCT03588884
  • Phase 3
    Terminated

    Safety & Efficacy Study Evaluating the Combination of Bevasiranib & Lucentis Therapy in Wet AMD

    bevasiranib, ranibizumab

    Macular Degeneration

    Enrollment
    338
    Start
    Aug 2007
    Primary Completion
    Mar 2009
    Completion
    May 2009
    NCT00499590
  • Phase 3
    Withdrawn

    Safety & Efficacy Study Evaluating the Combination of Bevasiranib & Lucentis Therapy in Wet AMD (CARBON)

    Bevasiranib, ranibizumab

    Age Related Macular Degeneration

    Enrollment
    0
    Start
    Nov 2009
    Primary Completion
    Jul 2011est.
    Completion
    Jul 2012est.
    NCT00557791
  • Phase 3
    Terminated

    A Phase 3, Multicenter Study To Evaluate The Efficacy And Safety Of MOD-4023 In Adults With Growth Hormone Deficiency

    MOD-4023

    Adult Growth Hormone Deficiency

    Enrollment
    202
    Start
    Jun 2013
    Primary Completion
    Aug 2016
    Completion
    Aug 2018
    NCT01909479
  • Phase 3
    Completed

    Extension Study of CTAP101-CL-3001 or CTAP101-CL-3002

    CTAP101 Capsules, Calcitriol

    Chronic Kidney Disease, Hyperparathyroidism, Secondary +1

    Enrollment
    298
    Start
    Apr 2013
    Primary Completion
    May 2015
    Completion
    May 2015
    NCT02282813
  • Phase 3
    Completed

    Safety and Efficacy Phase 3 Study of Long-acting hGH (MOD-4023) in Growth Hormone Deficient Children

    MOD-4023, Somatropin

    Pediatric Growth Hormone Deficiency

    Enrollment
    224
    Start
    Dec 2016
    Primary Completion
    Aug 2019
    Completion
    May 2024
    NCT02968004
  • Phase 3
    Completed

    Safety and Efficacy Study of MOD-4023 to Treat Children With Growth Hormone Deficiency

    MOD-4023, Genotropin

    Growth Hormone Deficiency

    Enrollment
    44
    Start
    Dec 2017
    Primary Completion
    Mar 2020
    Completion
    Mar 2020
    NCT03874013
  • Phase 3
    Terminated

    Phase 3 Safety and Efficacy Study of CTAP101 Extended-release Capsules in Children With Secondary Hyperparathyroidism

    CTAP101, Placebo

    Chronic Kidney Disease stage3, Chronic Kidney Disease stage4 +2

    Enrollment
    2
    Start
    Jan 2023
    Primary Completion
    Jun 2024
    Completion
    Jun 2024
    NCT05543928
  • Phase 2/3
    Completed

    Safety/Efficacy Study of CTAP101 in Chronic Kidney Disease Subjects With Secondary Hyperparathyroidism (SHPT)

    Cohort 1 CTAP101 Capsules- 60µg, Cohort 1 CTAP101 Capsules - 90µg

    Chronic Kidney Disease, Secondary Hyperparathyroidism +1

    Enrollment
    78
    Start
    Oct 2010
    Primary Completion
    Nov 2011
    Completion
    Nov 2011
    NCT01219855
  • Phase 2
    Completed

    Safety and Efficacy Study of Small Interfering Ribonucleic Acid (RNA) Molecule (Cand5) to Treat Wet Age-Related Macular Degeneration

    Bevasiranib

    Macular Degeneration

    Enrollment
    120
    Start
    Jul 2005
    Primary Completion
    Dec 2007
    Completion
    Dec 2007
    NCT00259753
  • Phase 2
    Completed

    Safety and Efficacy Study of Small Interfering RNA Molecule (Cand5) to Treat Diabetic Macular Edema

    bevasiranib

    Diabetic Macular Edema

    Enrollment
    48
    Start
    Jan 2006
    Primary Completion
    Sep 2007
    Completion
    Dec 2007
    NCT00306904
  • Phase 2
    Completed

    Safety and Efficacy of Topically Applied CTA018 in Plaque Psoriasis

    CTA018 cream

    Psoriasis

    Enrollment
    140
    Start
    Sep 2006
    Primary Completion
    May 2007
    Completion
    May 2007
    NCT00384098
  • Phase 2
    Completed

    ELND005 in Patients With Mild to Moderate Alzheimer's Disease

    Placebo Control, ELND005

    Alzheimer Disease

    Enrollment
    353
    Start
    Dec 2007
    Primary Completion
    May 2010
    Completion
    May 2010
    NCT00568776
  • Phase 2
    Completed

    A Trial of TT223 in Patients With Type 2 Diabetes Who Are Taking Metformin and/or Thiazolidinedione

    TT223 with Metformin and/or TZD, Placebo with Metformin and/or TZD

    Diabetes Mellitus, Type 2

    Enrollment
    87
    Start
    Aug 2008
    Primary Completion
    Dec 2009
    Completion
    Dec 2009
    NCT00743002
  • Phase 2
    Completed

    ELND005 Long-Term Follow-up Study in Subjects With Alzheimer's Disease

    ELND005 (scyllo-inositol)

    Alzheimer's Disease

    Enrollment
    103
    Start
    Jun 2009
    Primary Completion
    Jun 2011
    Completion
    Jun 2011
    NCT00934050
  • Phase 2
    Completed

    MOD-4023 (Long-Lasting Human Growth Hormone (hGH)) Study in Growth Hormone Deficient Adults (GHDA)

    MOD-4023, MOD-4023

    Adult Growth Hormone Deficiency

    Enrollment
    52
    Start
    Aug 2010
    Primary Completion
    Jul 2011
    Completion
    Apr 2012
    NCT01225666
  • Phase 2
    Withdrawn

    Four Week, Pharmacodynamic/Pharmacokinetic, Efficacy, and Safety Study of Lunacalcipol (CTA018)

    Lunacalcipol 180, Lunicalcipol 270

    Stage 5 Chronic Kidney Disease (CKD), Secondary Hyperparathyroidism (SHPT) +1

    Enrollment
    0
    Start
    Jan 2013
    Primary Completion
    Jul 2013est.
    Completion
    Jul 2013est.
    NCT01453634
  • Phase 2
    Completed

    Safety and Efficacy Phase 2 Study of Long-acting hGH (MOD-4023) in Growth Hormone Deficient Children

    MOD-4023, Somatropin

    Pediatric Growth Hormone Deficiency

    Enrollment
    56
    Start
    Feb 2012
    Primary Completion
    Jul 2015
    Completion
    Jul 2015
    NCT01592500
  • Phase 2
    Terminated

    Safety and Efficacy Study of ELND005 as an Adjunctive Maintenance Treatment in Bipolar I Disorder

    ELND005, Lamotrigine

    Bipolar 1 Disorder

    Enrollment
    309
    Start
    Aug 2012
    Primary Completion
    Jun 2014
    Completion
    Jun 2014
    NCT01674010
  • Phase 2
    Completed

    Efficacy and Safety Study of ELND005 as a Treatment for Agitation and Aggression in Alzheimer's Disease

    ELND005, Placebo

    Alzheimer's Disease

    Enrollment
    350
    Start
    Nov 2012
    Primary Completion
    May 2015
    Completion
    May 2015
    NCT01735630
  • Phase 2
    Terminated

    A 36-Week Safety Extension Study of ELND005 as a Treatment for Agitation and Aggression in Alzheimer's Disease

    Group 1 ELND005, Group 2 ELND005

    Alzheimer's Disease

    Enrollment
    296
    Start
    Jan 2013
    Primary Completion
    Aug 2015
    Completion
    Aug 2015
    NCT01766336
  • Phase 2
    Completed

    A 4-Week Safety Study of Oral ELND005 in Young Adults With Down Syndrome Without Dementia

    ELND005, Placebo

    Down Syndrome

    Enrollment
    23
    Start
    Sep 2013
    Primary Completion
    Jun 2014
    Completion
    Jun 2014
    NCT01791725
  • Phase 2
    Completed

    A Study to Compare a New Drug for Type 2 Diabetes to Placebo and to a Treatment Already Available for Type 2 Diabetes

    LY2944876, Exenatide extended-release

    Diabetes Mellitus, Type 2

    Enrollment
    420
    Start
    Apr 2014
    Primary Completion
    Aug 2015
    Completion
    Oct 2015
    NCT02119819
  • Phase 2
    Completed

    Long Term Follow up Study of Long-acting hGH (MOD-4023) in Growth Hormone Deficient Children

    MOD-4023

    Growth Hormone Deficiency (GHD)

    Enrollment
    48
    Start
    Feb 2014
    Primary Completion
    Nov 2023
    Completion
    Nov 2023
    NCT02500316
  • Phase 2
    Terminated

    Effects and Safety of OPK-88004 Doses in Men With Signs and Symptoms of Benign Prostatic Hyperplasia (BPH)

    Group-1 (15mg, OPK-88004), Group-2 (25 mg,OPK-88004)

    Benign Prostatic Hyperplasia

    Enrollment
    114
    Start
    Feb 2018
    Primary Completion
    Apr 2019
    Completion
    Jun 2019
    NCT03297398

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