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Opko Health (OPK)
:OPK
Ctap101
Secondary Hyperparathyroidism, Chronic Kidney Disease Stage3, Chronic Kidney Disease Stage4, Vitamin D Deficiency
Phase III
Terminated
Phase 3 Safety and Efficacy Study of CTAP101 Extended-release Capsules in Children With Secondary Hyperparathyroidism
Sep 13, 2022
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Calcifediol Oral Capsule
Chronic Kidney Diseases, Secondary Hyperparathyroidism Due To Renal Causes, Vitamin D Deficiency, Stage 5 Chronic Kidney Disease
Phase II
Terminated
Safety, Efficacy, PK and PD of CTAP101 (Calcifediol) ER Capsules for SHPT in HD Patients VDI
Jul 13, 2018
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Mod-4023, Somatropin
Pediatric Growth Hormone Deficiency
Phase III
Completed
Safety and Efficacy Phase 3 Study of Long-acting hGH (MOD-4023) in Growth Hormone Deficient Children
Nov 13, 2016
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Mod-4023
Growth Hormone Deficiency (Ghd)
Phase II
Completed
Long Term Follow up Study of Long-acting hGH (MOD-4023) in Growth Hormone Deficient Children
Jul 12, 2015
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FAQ
What are the FDA phases for drug approval?
The FDA approval process for new drugs is divided into several phases:
a. Preclinical testing
b. Phase 1 – Safety and dosage
c. Phase 2 – Effectiveness and side effects
d. Phase 3 – Confirmation of effectiveness, monitoring of adverse reactions, and comparison with existing treatments
e. Phase 4 – Post-marketing studies to track long-term safety and effectiveness
a. Preclinical testing
b. Phase 1 – Safety and dosage
c. Phase 2 – Effectiveness and side effects
d. Phase 3 – Confirmation of effectiveness, monitoring of adverse reactions, and comparison with existing treatments
e. Phase 4 – Post-marketing studies to track long-term safety and effectiveness
What is a clinical trial?
A clinical trial is a carefully designed study in which researchers test a drug, treatment, or medical device in people to evaluate its safety, effectiveness, and potential side effects. These trials are essential for determining whether a new treatment should be approved for widespread use.
What drugs does Opko Health (OPK) have in its pipeline
OPK is currently developing the following drugs: Ctap101, Calcifediol Oral Capsule, Mod-4023, Somatropin. These drug candidates are in various stages of clinical development as the company works toward FDA approval.