Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
CTAP201 · 1 trial · 4 indications
| Arm | Type | Description |
|---|---|---|
| CTAP201 Injection at dose a | EXPERIMENTAL | CTAP201 at dose a |
| CTAP201 Injection | EXPERIMENTAL | CTAP201 at dose b or dose c |
| Doxercalciferol at dose a | ACTIVE_COMPARATOR | Active at dose a |
| Doxercalciferol | ACTIVE_COMPARATOR | Active at dose b or dose c |
| Name | Type | Description |
|---|---|---|
| CTAP201 Injection | DRUG | Comparison of different dose strengths of CTAP201 after single dose. |
| Doxercalciferol | DRUG | Comparison of different dose strengths of doxercalciferol after single dose. |
Inclusion Criteria: * Body mass index between 18 and 40 * On maintenance hemodialysis three times per week * Visit 1: Serum iPTH value greater than or equal to 200 pg/mL and lower than or equal to 1000 pg/mL * Visit 1: Serum total calcium value greater than 8.4 mg/dL and lower than 10.0 mg/dL * Vis...
Top 20 of 25 competitors
CTAP201 is an investigational small molecule being developed for chronic kidney disease, specifically for secondary hyperparathyroidism in patients with chronic kidney disease. It is in Phase 1 clinical development by Opko Health Inc. (OPK).
CTAP201 is being developed by Opko Health Inc., a biopharmaceutical company traded on the Nasdaq under the ticker OPK. The drug is currently in Phase 1 clinical development for chronic kidney disease.
CTAP201 is in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA. A Phase 1 clinical trial for the drug has been completed.
CTAP201 has one completed Phase 1 clinical trial, NCT00792857, which compared intravenous CTAP201 with doxercalciferol (Hectorol) in subjects with chronic kidney disease and secondary hyperparathyroidism. The trial enrolled 24 participants in the United States.
CTAP201 is not the same as Hectorol (doxercalciferol). In a clinical trial, CTAP201 was compared against doxercalciferol as an active control, meaning they are distinct treatments being evaluated against each other.