Overview
Odevixibat, or A4250, is an ileal sodium/bile acid cotransporter inhibitor indicated for the treatment of pruritus in patients older than 3 months, with progressive familiar intrahepatic cholestasis (PFIC). Odevixibat is the first approved non-surgical treatment option for PFIC. Previous therapies for PFIC included a bile acid sequestrant such as ursodeoxycholic acid. Odevixibat was granted FDA approval on 20 July 2021.
Indication
Odevixibat is indicated for the treatment of pruritus in patients older than 3 months with progressive familiar intrahepatic cholestasis (PFIC) and cholestatic pruritus in patients 12 months of age and older with Alagille Syndrome. It may not be effective in patients with PFIC type 2 with ABCB11 variants since these patients lack a functional bile salt export pump.
Associated Conditions
- Cholestatic pruritus
- Pruritus
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2022/06/22 | Phase 3 | ENROLLING_BY_INVITATION | Albireo, an Ipsen Company | ||
2021/09/05 | Phase 3 | Recruiting | Albireo, an Ipsen Company | ||
2020/12/19 | Phase 3 | Completed | |||
2020/07/23 | N/A | APPROVED_FOR_MARKETING | |||
2020/04/07 | Phase 3 | Active, not recruiting | Albireo, an Ipsen Company | ||
2018/07/31 | Phase 1 | Completed | |||
2016/11/15 | Phase 1 | Completed | |||
2015/12/15 | Phase 2 | Completed | |||
2015/02/11 | Phase 2 | Terminated | Sahlgrenska University Hospital, Sweden |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Albireo Pharma, Inc. | 74528-120 | ORAL | 1200 ug in 1 1 | 6/15/2023 | |
| Albireo Pharma, Inc. | 74528-060 | ORAL | 600 ug in 1 1 | 6/15/2023 | |
| Albireo Pharma, Inc. | 74528-040 | ORAL | 400 ug in 1 1 | 6/15/2023 | |
| Albireo Pharma, Inc. | 74528-020 | ORAL | 200 ug in 1 1 | 6/15/2023 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
Authorised | 9/19/2024 | ||
Authorised | 9/19/2024 | ||
Authorised | 7/16/2021 | ||
Authorised | 7/16/2021 | ||
Authorised | 9/19/2024 | ||
Authorised | 9/19/2024 | ||
Authorised | 7/16/2021 | ||
Authorised | 7/16/2021 |
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No HSA approvals found for this drug. | |||||
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| No NMPA approvals found for this drug. | |||||
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| No PPB approvals found for this drug. | |||||
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| BYLVAY odevixibat 1200 microgram capsule bottle | 419592 | Medicine | A | 3/26/2025 | |
| BYLVAY odevixibat 600 microgram capsule bottle | 419593 | Medicine | A | 3/26/2025 | |
| BYLVAY odevixibat 400 microgram capsule bottle | 419591 | Medicine | A | 3/26/2025 | |
| BYLVAY odevixibat 200 microgram capsule bottle | 419590 | Medicine | A | 3/26/2025 |
Health Canada Drug Approvals
Approved Product | Company | DIN | Dosage Form | Strength | Market Date |
|---|---|---|---|---|---|
| BYLVAY | medison pharma canada inc. | 02542692 | Capsule - Oral | 1200 MCG | 2/7/2024 |
| BYLVAY | medison pharma canada inc. | 02542684 | Capsule - Oral | 600 MCG | 3/6/2024 |
| BYLVAY | medison pharma canada inc. | 02542676 | Capsule - Oral | 400 MCG | 2/7/2024 |
| BYLVAY | medison pharma canada inc. | 02542641 | Capsule - Oral | 200 MCG | 2/7/2024 |
CIMA AEMPS Drug Approvals
Approved Product | Company | Registration Number | Pharmaceutical Form | Prescription Type | Status |
|---|---|---|---|---|---|
| No CIMA AEMPS (Spain) approvals found for this drug. | |||||
Philippines FDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Philippines FDA approvals found for this drug. | |||||
Saudi SFDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Saudi SFDA approvals found for this drug. | |||||
Malaysia NPRA Drug Approvals
Approved Product | Company | Registration Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Malaysia NPRA approvals found for this drug. | |||||
UK EMC Drug Information
Medicine Name | MA Holder | MA Number | Pharmaceutical Form | Active Ingredient | Authorization Date |
|---|---|---|---|---|---|
| No UK EMC drug information found for this drug. | |||||
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