Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
BPS804/Kg · 1 trial · 2 indications
| Arm | Type | Description |
|---|---|---|
| BPS804 dosing frequency 1 | EXPERIMENTAL | Subjects dosed 20mg/Kg BPS804 monthly |
| placebo dosing frequency 1 | PLACEBO_COMPARATOR | Subjects dosed with matching placebo to 20mg/Kg BPS804 monthly |
| BPS804 dosing frequency 2 | EXPERIMENTAL | Subjects dosed with 20mg/Kg BPS804 quarterly |
| placebo dosing frequency 2 | PLACEBO_COMPARATOR | Subjects dosed with matching placebo to 20mg/Kg BPS804 every 3 months |
| BPS804 dosing frequency 3 | EXPERIMENTAL | Subjects dosed with 20mg/Kg BPS804 weekly |
| Placebo dosing frequency 3 | PLACEBO_COMPARATOR | Subjects dosed with matching placebo to 20mg/Kg BPS804 weekly |
| Name | Type | Description |
|---|---|---|
| BPS804 20mg/Kg | DRUG | - |
| Placebo to 20mg/Kg BPS804 | DRUG | - |
Inclusion Criteria: * Postmenopausal women (natural or surgically induced menopause) * Low bone mineral density (BMD), as defined by a T score or equivalent BMD absolute value (g/cm2) for lumbar spine of between -2.0 and -3.5, inclusive * Body mass index (BMI) must be within the range of 18 to 35kg...
BPS804 is an investigational small molecule being studied for rare bone disorders, including Osteogenesis Imperfecta, Hypophosphatasia, and Osteopenia. It has been evaluated in Phase 2 clinical trials for these conditions, which are characterized by low bone mineral density or impaired bone mineralization.
BPS804 is being developed by Ultragenyx Pharmaceutical Inc., a biopharmaceutical company traded on NASDAQ under the ticker RARE. The company focuses on therapies for rare and ultrarare diseases.
BPS804 is in Phase 2 clinical development. It has completed Phase 2 trials for Osteogenesis Imperfecta, Hypophosphatasia, and Osteopenia. As an investigational drug, it has not been approved by regulatory authorities and remains under clinical study.
BPS804 has been studied in three completed Phase 2 trials. NCT01406548 evaluated multiple dosing regimens in postmenopausal women with low bone mineral density. NCT01406977 was a dose escalation study in adults with Hypophosphatasia. NCT01417091 assessed safety, pharmacokinetics, and pharmacodynamics in Osteogenesis Imperfecta.
BPS804 is also known as setrusumab. This alternative name is used in some clinical and scientific contexts to refer to the same investigational drug being developed by Ultragenyx for rare bone diseases.