Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
LJPC-401 · 1 trial · 1 indication
Percentage change in transferrin saturation (TSAT) as measured by blood laboratory tests.
| Arm | Type | Description |
|---|---|---|
| LJPC-401 | ACTIVE_COMPARATOR | LJPC-401 solution for subcutaneous injection only, 5mg/1 mL (5mg/mL) or 10mg/1mL (10mg/mL) single use vial |
| Placebo | PLACEBO_COMPARATOR | 0.9% Sodium Chloride Injection, USP, or equivalent |
| Name | Type | Description |
|---|---|---|
| LJPC-401 | DRUG | LJPC-401 subcutaneous injection, up to 20 mg weekly for 16 weeks. The minimum weekly dose will be 5 mg and the maximum weekly dose of LJPC-401 will be 20 mg. |
| Placebo | DRUG | 0.9% Sodium Chloride Injection, USP, or equivalent |
Inclusion Criteria: 1. Patients with clinical diagnosis of hereditary hemochromatosis 2. Patients who are prescribed therapeutic phlebotomy for treatment of hereditary hemochromatosis 3. Patients with serum ferritin and TSAT levels above treatment guidelines 4. Female patients of child bearing pote...
LJPC-401 is an investigational small molecule being developed for the treatment of iron overload in adult patients with hereditary hemochromatosis, a rare disease. It is currently in Phase 2 clinical development and is not yet approved by regulatory authorities.
LJPC-401 is being developed by Innoviva, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol INVA. The drug is in Phase 2 clinical development for hereditary hemochromatosis.
LJPC-401 is in Phase 2 clinical development. It is an investigational drug and has not been approved by the FDA or any other regulatory agency. A Phase 2 clinical trial for the drug has been completed.
LJPC-401 has one completed Phase 2 clinical trial, identified as NCT03395704, which studied the drug for the treatment of iron overload in adult patients with hereditary hemochromatosis. The trial enrolled 70 participants and was conducted in the United States, Australia, France, and the United Kingdom.
No, LJPC-401 is not the same as hepcidin. LJPC-401 is a small molecule being developed by Innoviva, Inc. for hereditary hemochromatosis. Hepcidin is a naturally occurring hormone that regulates iron levels, but LJPC-401 is a distinct investigational drug.