Our Research

Nephrology

Our lead nephrology product, Rayaldee®, is approved by the U.S Food and Drug Administration (FDA) for the treatment of secondary hyperparathyroidism (SHPT) in patients with stage 3-4 chronic kidney disease (CKD) with vitamin D insufficiency. A phase 2 clinical trial to evaluate the safety and efficacy of Rayaldee® to treat SHPT is currently underway in patients with stage 5 CKD who require regular hemodialysis.

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Urology

Selective androgen receptor modulators (SARMs) are a class of androgen receptor ligands exhibiting modified anabolic and androgenic effects. We believe OPK88004 holds considerable promise for a variety of clinical indications, such as frailty and functional limitations associated with aging and chronic illnesses, cancer and osteoporosis.

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Endocrinology

hGH-CTP

Our human growth hormone (hGH) therapy utilizes proprietary carboxyl-terminal peptide (CTP) technology to extend the therapeutic life of hGH, requiring once weekly injections as opposed to daily injections using current treatments. hGH-CTP is currently being evaluated in a phase 3 clinical trial as a treatment for children with growth hormone deficiency (GHD), and is partnered with the Pfizer Corporation.

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OPK88003 (Oxyntomodulin Analog)

The naturally occurring peptide oxyntomodulin is a dual agonist, that binds to both GLP-1 and glucagon receptors, regulating metabolic function, including blood-glucose, and suppressing appetite. OPK88003, an oxyntomodulin analog, is being developed for the treatment of obesity and diabetes.

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Product Pipeline

Rayaldee®

SHPT (CKD stage 5)

Preclinical	Phase 1	Phase 2	Phase 3	Market
Preclinical Phase complete	Phase 1 Phase complete	Phase 2 Phase in progress	Phase 3 Phase not started	Market Phase not started

Phase 2 in progress (F: 1H 2020)

Alpharen® (Fermagate)

Hypophosphatemia (CKD Stage 5)

Preclinical	Phase 1	Phase 2	Phase 3	Market
Preclinical Phase complete	Phase 1 Phase complete	Phase 2 Phase in progress	Phase 3 Phase not started	Market Phase not started

Phase 3 Ready

OPK88003 (Oxyntomodulin)

Obesity and Diabetes

Preclinical	Phase 1	Phase 2	Phase 3	Market
Preclinical Phase complete	Phase 1 Phase complete	Phase 2 Phase in progress	Phase 3 Phase not started	Market Phase not started

Phase 2 Complete March 2019

OPK88004 (SARM)

Exploratory

Preclinical	Phase 1	Phase 2	Phase 3	Market
Preclinical Phase complete	Phase 1 Phase in progress	Phase 2 Phase not started	Phase 3 Phase not started	Market Phase not started

Phase 2

OPK88005 (Factor VIIa-CTP)

Hemophilia

Preclinical	Phase 1	Phase 2	Phase 3	Market
Preclinical Phase complete	Phase 1 Phase complete	Phase 2 Phase in progress	Phase 3 Phase not started	Market Phase not started

IV administration: Phase 2a completed

Preclinical	Phase 1	Phase 2	Phase 3	Market
Preclinical Phase complete	Phase 1 Phase in progress	Phase 2 Phase not started	Phase 3 Phase not started	Market Phase not started

Subcutaneous Administration: Phase 1 completed

hGH-CTP

Growth hormone deficiency

Preclinical	Phase 1	Phase 2	Phase 3	Market
Preclinical Phase complete	Phase 1 Phase complete	Phase 2 Phase complete	Phase 3 Phase in progress	Market Phase not started

Adults: Phase 3 complete

Preclinical	Phase 1	Phase 2	Phase 3	Market
Preclinical Phase complete	Phase 1 Phase complete	Phase 2 Phase complete	Phase 3 Phase in progress	Market Phase not started

Pediatrics: Phase 3 in progress, enrollment complete (3Q 2018)

OPK88001 (AntagoNAT)

Dravet Syndrome

Preclinical	Phase 1	Phase 2	Phase 3	Market
Preclinical Phase in progress	Phase 1 Phase not started	Phase 2 Phase not started	Phase 3 Phase not started	Market Phase not started

Pre-clinical

Publications

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