Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as CTAP201 Injection
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 28 competitors
CTAP201 is an investigational small molecule developed by Opko Health Inc. for chronic kidney disease. It was studied in a Phase 1 trial comparing intravenous CTAP201 with doxercalciferol in patients with chronic kidney disease and secondary hyperparathyroidism. CTAP201 is also known as CTAP201 Injection.
CTAP201 was studied for the treatment of chronic kidney disease, specifically in patients with secondary hyperparathyroidism. The Phase 1 trial enrolled patients with chronic kidney disease, secondary hyperparathyroidism, chronic renal insufficiency, and chronic renal failure. It is an investigational therapy and has not been approved for any indication.
CTAP201 is developed by Opko Health Inc., which trades on the Nasdaq under the ticker OPK. Opko Health sponsored the Phase 1 trial of CTAP201 in patients with chronic kidney disease and secondary hyperparathyroidism.
CTAP201 is in Phase 1 development. It has completed one Phase 1 clinical trial and is not currently listed as active in any trials. As an investigational small molecule, CTAP201 has not been approved by the FDA for any indication.
CTAP201 has been studied in one completed Phase 1 trial, NCT00792857, titled Comparison of I.V. CTAP201 and Doxercalciferol (Hectorol) in Subjects With Chronic Kidney Disease (CKD) and Secondary Hyperparathyroidism (SHPT). The trial enrolled 24 participants in the United States and used an active-controlled, randomized design.
Yes, CTAP201 Injection is an alternative name for CTAP201. Both refer to the same investigational small molecule developed by Opko Health Inc. for chronic kidney disease and secondary hyperparathyroidism.