Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
CTAP101 30 μg · 2 trials · 3 indications
Number of subjects in the intent to treat population attaining mean decrease in plasma intact Parathyroid Hormone (iPTH) of ≥30% from P\\pre-treatment baseline in the efficacy assessment phase (EAP) referred to as responders
Number of subjects in the intent to treat population attaining a mean decrease in plasma intact parathyroid hormone (iPTH) of ≥30% from pre-treatment baseline in the efficacy assessment phase (EAP), referred to as responders.
| Arm | Type | Description |
|---|---|---|
| CTAP101 30 μg capsules | ACTIVE_COMPARATOR | 1 CTAP101 30 μg capsule daily at bedtime for 12 weeks, with a possible increase to 2 CTAP101 30 μg capsules daily at bedtime for study duration, if needed (26 weeks total). Subjects not requiring a dose increase after 12 weeks would receive 1 CTAP101 30 μg capsule and one sugar pill (to CTAP101 30 μg capsule) for weeks 13-26. |
| Sugar pill to CTAP101 30 μg | PLACEBO_COMPARATOR | 1 sugar pill to CTAP101 30 μg capsule daily at bedtime for 12 weeks, with an increase to 2 sugar pills to CTAP101 30 μg capsules daily at bedtime for weeks 13-26. |
| Sugar pill to CTAP101 30 μg capsule | PLACEBO_COMPARATOR | 1 sugar pill to CTAP101 30 μg capsule daily at bedtime for 12 weeks, with an increase to 2 sugar pills to CTAP101 30 μg capsules daily at bedtime for weeks 13-26. |
| Name | Type | Description |
|---|---|---|
| CTAP101 30 μg capsules | DRUG | CTAP101 30 μg capsule taken daily at bedtime |
| Sugar pill to CTAP101 30 μg capsules | OTHER | Sugar pill capsule (placebo to CTAP101 30 μg capsule) taken daily at bedtime. |
Inclusion Criteria: 1. Urinary albumin excretion ≤ 3000 mcg/mg of creatinine 2. Stage 3 or 4 CKD 3. Plasma iPTH: ≥ 85 pg/mL and \< 500 pg/mL 4. Serum Ca: ≥ 8.4 mg/dL and \< 9.8 mg/dL 5. Serum P: ≥ 2.0 mg/dL and \< 5.0 mg/dL 6. Serum 25-hydroxyvitamin D: ≥ 10 ng/mL and \< 30 ng/mL. 7. Stable dose of...
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CTAP101 30 μg is an investigational small molecule being developed for chronic kidney disease (CKD), specifically to treat secondary hyperparathyroidism in patients with stage 3 or 4 CKD and vitamin D insufficiency. It is currently in Phase 3 clinical development and has not been approved by the FDA.
CTAP101 30 μg is a small molecule being studied for its effects on secondary hyperparathyroidism in chronic kidney disease. The specific molecular target is not disclosed in the available information, but the drug is intended to address vitamin D insufficiency and related parathyroid hormone dysregulation in CKD patients.
CTAP101 30 μg is being developed by Opko Health Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol OPK. The company is conducting Phase 3 clinical trials to evaluate the drug's safety and efficacy in patients with chronic kidney disease and secondary hyperparathyroidism.
CTAP101 30 μg is in Phase 3 clinical development. Two Phase 3 trials have been completed, both evaluating the drug's safety and efficacy in treating secondary hyperparathyroidism in stage 3 or 4 chronic kidney disease with vitamin D insufficiency. The drug remains investigational and is not yet FDA approved.
CTAP101 30 μg has been studied in two completed Phase 3 clinical trials: NCT01651000 and NCT01704079. Both trials enrolled a total of 429 patients with chronic kidney disease, secondary hyperparathyroidism, and vitamin D deficiency. The trials were randomized, double-blind, placebo-controlled, and conducted in the United States.
CTAP101 30 μg is a specific dose formulation of CTAP101, a drug candidate being developed by Opko Health Inc. for secondary hyperparathyroidism in chronic kidney disease. The 30 μg designation refers to the dose strength studied in clinical trials, while CTAP101 refers to the drug substance itself.