Skip to main content

Go Premium in Our Biggest Sale Ever

UPGRADE NOW
TipRanks
Go Ultimate75% OFF

Opko Health (XCY) Drug Pipeline

3 Followers
Drug pipeline
Drug NameConditionStageStatusStudy NameTrial Start DateArticle
Ctap101Secondary Hyperparathyroidism, Ckd Stage 3, Ckd Stage 4, VdiPhase IIRecruitingPharmacokinetics, Pharmacodynamics, Safety and Tolerability Evaluation of CTAP101 Extended-release Capsules in Pediatric ParticipantsMar 20, 2026―
Opk-88006Mashphase1AndPhase2RecruitingPhase 1/2 Study of OPK-88006 in Healthy and Presumed MASH ParticipantsDec 08, 2025
Ctap101Secondary Hyperparathyroidism, Chronic Kidney Disease Stage3, Chronic Kidney Disease Stage4, Vitamin D DeficiencyPhase IIITerminatedPhase 3 Safety and Efficacy Study of CTAP101 Extended-release Capsules in Children With Secondary HyperparathyroidismSep 13, 2022―
Calcifediol Oral CapsuleChronic Kidney Diseases, Secondary Hyperparathyroidism Due To Renal Causes, Vitamin D Deficiency, Stage 5 Chronic Kidney DiseasePhase IITerminatedSafety, Efficacy, PK and PD of CTAP101 (Calcifediol) ER Capsules for SHPT in HD Patients VDIJul 13, 2018―
Mod-4023, SomatropinPediatric Growth Hormone DeficiencyPhase IIICompletedSafety and Efficacy Phase 3 Study of Long-acting hGH (MOD-4023) in Growth Hormone Deficient ChildrenNov 13, 2016―
Mod-4023Growth Hormone Deficiency (Ghd)Phase IICompletedLong Term Follow up Study of Long-acting hGH (MOD-4023) in Growth Hormone Deficient ChildrenJul 12, 2015―

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
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 (DE:XCY) have in its pipeline
Opko Health DE:XCY is currently developing the following drugs: Ctap101, Opk-88006, Calcifediol Oral Capsule, Mod-4023, Somatropin, Mod-4023. These drug candidates are in various stages of clinical development as the company works toward FDA approval.