Overview
Nitisinone is a synthetic reversible inhibitor of 4-hydroxyphenylpyruvate dioxygenase. It is used in the treatment of hereditary tyrosinemia type 1. It is sold under the brand name Orfadin.
Background
Nitisinone is a synthetic reversible inhibitor of 4-hydroxyphenylpyruvate dioxygenase. It is used in the treatment of hereditary tyrosinemia type 1. It is sold under the brand name Orfadin.
Indication
Used as an adjunct to dietary restriction of tyrosine and phenylalanine in the treatment of hereditary tyrosinemia type 1.
Associated Conditions
- Tyrosinemia Type 1
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2024/01/26 | N/A | Recruiting | |||
2019/10/03 | Not Applicable | UNKNOWN | Sutphin Drugs | ||
2017/04/06 | Phase 1 | Completed | |||
2016/04/25 | Phase 1 | Completed | |||
2016/04/25 | Phase 1 | Completed | |||
2016/04/25 | Phase 1 | Completed | |||
2014/12/23 | Phase 3 | Completed | |||
2014/12/19 | N/A | Completed | |||
2013/08/05 | Phase 3 | UNKNOWN | |||
2013/05/20 | Phase 1 | Completed |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Torrent pharmaceuticals limited | 13668-631 | ORAL | 10 mg in 1 1 | 1/10/2023 | |
| Eton Pharmaceuticals, Inc. | 71863-119 | ORAL | 2 mg in 1 1 | 12/27/2023 | |
| Par Pharmaceutical, Inc. | 0254-3020 | ORAL | 2 mg in 1 1 | 11/12/2019 | |
| Cycle Pharmaceuticals Ltd. | 70709-000 | ORAL | 10 mg in 1 1 | 11/14/2018 | |
| Eton Pharmaceuticals, Inc. | 71863-121 | ORAL | 10 mg in 1 1 | 12/27/2023 | |
| Bryant Ranch Prepack | 63629-2234 | ORAL | 2 mg in 1 1 | 11/12/2019 | |
| Swedish Orphan Biovitrum AB (publ) | 66658-204 | ORAL | 4 mg in 1 mL | 6/20/2022 | |
| Torrent pharmaceuticals limited | 13668-629 | oral | 2 mg in 1 1 | 1/10/2023 | |
| Eton Pharmaceuticals, Inc. | 71863-120 | ORAL | 5 mg in 1 1 | 12/27/2023 | |
| Torrent pharmaceuticals limited | 13668-630 | oral | 5 mg in 1 1 | 1/10/2023 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
Cycle Pharmaceuticals (Europe) Ltd,70 Sir John Rogerson's Quay,Dublin 2,Ireland | Authorised | 7/26/2018 | |
Authorised | 2/21/2005 |
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 |
|---|---|---|---|---|---|
| Nitisinone Capsules | 国药准字HJ20233127 | 化学药品 | 胶囊剂 | 2/14/2023 | |
| Nitisinone Capsules | 国药准字HJ20233130 | 化学药品 | 胶囊剂 | 2/14/2023 | |
| Nitisinone Capsules | 国药准字HJ20210043 | 化学药品 | 胶囊剂 | 6/16/2021 | |
| Nitisinone Capsules | 国药准字HJ20210042 | 化学药品 | 胶囊剂 | 6/16/2021 | |
| Nitisinone Capsules | 国药准字HJ20210044 | 化学药品 | 胶囊剂 | 6/16/2021 | |
| Nitisinone Capsules | 国药准字HJ20233129 | 化学药品 | 胶囊剂 | 2/14/2023 | |
| Nitisinone Capsules | 国药准字HJ20233128 | 化学药品 | 胶囊剂 | 2/14/2023 | |
| Nitisinone Oral Suspension | 国药准字HJ20233126 | 化学药品 | 口服混悬剂 | 2/14/2023 |
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 |
|---|---|---|---|---|---|
| ORFADIN nitisinone 5 mg capsule bottle | 164173 | A Menarini Australia Pty Ltd | Medicine | A | 11/22/2010 |
| NITYR nitisinone 5 mg tablet bottle | 288128 | Medicine | A | 6/8/2018 | |
| NITYR nitisinone 10 mg tablet bottle | 288126 | Medicine | A | 6/8/2018 | |
| ORFADIN nitisinone 10 mg capsule bottle | 164174 | A Menarini Australia Pty Ltd | Medicine | A | 11/22/2010 |
| ORFADIN nitisinone 2 mg capsule bottle | 164163 | A Menarini Australia Pty Ltd | Medicine | A | 11/22/2010 |
| NITYR nitisinone 2 mg tablet bottle | 288127 | Medicine | A | 6/8/2018 | |
| ORFADIN nitisinone 20 mg capsule bottle | 297735 | A Menarini Australia Pty Ltd | Medicine | A | 2/26/2019 |
| ORFADIN nitisinone 4 mg/mL oral suspension bottle | 297736 | A Menarini Australia Pty Ltd | Medicine | A | 2/26/2019 |