Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
MBX-8025 · 3 trials · 3 indications
Relative change from baseline in serum ALP levels at Week 8 (endpoint). The modified Intent-to-Treat (mITT) analysis set included all randomized subjects with confirmed PBC who received at least one study drug dose and had at least one post baseline ALP evaluation on treatment. n, denotes number of subjects evaluable for the respective timepoints
Absolute and percentage (%) reduction in serum LDL-C at any point from baseline through Week 16.
| Arm | Type | Description |
|---|---|---|
| MBX-8025 (2 mg) | EXPERIMENTAL | MBX-8025 2 mg capsule once daily |
| MBX-8025 (5 mg) | EXPERIMENTAL | MBX-8025 5 mg capsule once daily |
| MBX-8025 (10 mg) | EXPERIMENTAL | MBX-8025 10 mg capsule once daily |
| placebo, MBX-8025 50 mg, 100 mg or 200 mg capsules | EXPERIMENTAL | - |
| Placebo/Placebo | PLACEBO_COMPARATOR | - |
| MBX-8025 50 mg/Placebo | EXPERIMENTAL | - |
| MBX-8025 100 mg/Placebo | EXPERIMENTAL | - |
| Placebo/Atorvastatin 20 mg | ACTIVE_COMPARATOR | - |
| MBX-8025 50 mg/Atorvastatin 20 mg | EXPERIMENTAL | - |
| MBX-8025 100 mg/Atorvastatin 20 mg | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| MBX-8025 2 mg Capsule | DRUG | Initial 8-week treatment: • MBX-8025 2 mg Extension: The 2 mg group will be started after safety and efficacy review of the 5 mg and the 10 mg groups has been completed. Subjects will initially enter the extension on their assigned dose. The dose might be up- or down-titrated after safety and efficacy data review of the first 8 weeks of treatment. During the extension, a subject's dose might be re-adjusted for safety or efficacy reasons. |
| MBX-8025 5 mg Capsule | DRUG | Initial 8-week treatment: • MBX-8025 5 mg Extension: Subjects will initially enter the extension on their assigned dose. The dose might be up- or down-titrated after safety and efficacy data review of the first 8 weeks of treatment. During the extension, a subject's dose might be re-adjusted for safety or efficacy reasons. |
| MBX-8025 10 mg Capsule | DRUG | Initial 8-week treatment: • MBX-8025 10 mg Extension: Subjects will initially enter the extension on their assigned dose. The dose might be up- or down-titrated after safety and efficacy data review of the first 8 weeks of treatment. During the extension, a subject's dose might be re-adjusted for safety or efficacy reasons. |
| Run-In Period: Placebo | OTHER | 2 capsules, once a day for two weeks |
| MBX-8025 50 mg (Dose Escalation Period 1) | DRUG | 1 capsule once a day for 4 weeks (MBX-8025 50 mg capsule) |
| MBX-8025 50 mg or 100 mg (Dose Escalation Period 2) | DRUG | 1 capsule once a day for 4 weeks (MBX-8025 50 mg or 100 mg capsule) |
| MBX-8025 50 mg, 100 mg or 200 mg (Dose Escalation Period 3) | DRUG | 1 or 2 capsules once a day for 4 weeks (MBX-8025 50 mg, 100 mg or two (2) 100 mg capsules) |
| Placebo | DRUG | 2 capsules, once a day for 8 weeks |
| MBX-8025 | DRUG | 2 capsules, once daily for 8 weeks |
| Atorvastatin | DRUG | 2 capsules, once daily for 8 weeks |
Inclusion Criteria: 1. Must have given written informed consent (signed and dated) and any authorizations required by local law 2. 18 to 75 years old (inclusive) 3. Male or female with a diagnosis of PBC, by at least two of the following criteria: * History of AP above ULN for at least six mont...
MBX-8025 is an investigational small molecule being studied for Homozygous Familial Hypercholesterolemia, Primary Biliary Cirrhosis, and Hyperlipidemia. It is in Phase 2 clinical development and has not been approved by the FDA.
MBX-8025 is being developed by Gilead Sciences, Inc., which trades on the NASDAQ under the ticker GILD. The drug is currently in Phase 2 clinical trials for metabolic conditions.
MBX-8025 is in Phase 2 clinical development. It is investigational and has not received FDA approval. All three completed trials for the drug were Phase 2 studies.
MBX-8025 has completed three Phase 2 trials: NCT00701883 in Hyperlipidemia with 183 patients, NCT02472535 in Homozygous Familial Hypercholesterolemia with 13 patients, and NCT02955602 in Primary Biliary Cirrhosis with 119 patients.
Yes, MBX-8025 is also known as seladelpar. One of its completed trials, NCT02955602, is titled 'Seladelpar (MBX-8025) in Subjects With Primary Biliary Cholangitis (PBC)', confirming the alternative name.