TipRanks
Go Ultimate55% OFF

Opko Health (OPK) Drug Pipeline

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 (MX:OPK) have in its pipeline
Opko Health MX:OPK 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.