Overview
Rilonacept is a dimeric fusion protein consisting of portions of IL-1R and the IL-1R accessory protein linked to the Fc portion of immunoglobulin G1. Rilonacept functions as an interleukin 1 inhibitor and is used in the treatment of CAPS, also known as cryopyrin-associated periodic syndromes, including familial cold auto-inflammatory syndrome (FCAS) and Muckle-Wells Syndrome (MWS), in adults and children greater than 12 years old.
Background
Rilonacept is a dimeric fusion protein consisting of portions of IL-1R and the IL-1R accessory protein linked to the Fc portion of immunoglobulin G1. Rilonacept functions as an interleukin 1 inhibitor and is used in the treatment of CAPS, also known as cryopyrin-associated periodic syndromes, including familial cold auto-inflammatory syndrome (FCAS) and Muckle-Wells Syndrome (MWS), in adults and children greater than 12 years old.
Indication
用于治疗成人及12岁青少年罕见病周期性综合征(CAPS),即家族性寒冷型自身炎症综合征和穆-韦（Muckle-Wells）两氏综合征。
Associated Conditions
- Cryopyrin-associated Periodic Syndromes (CAPS)
- Deficiency of the interleukin-1 receptor antagonist
- Familial Cold Autoinflammatory Syndrome (FCAS)
- Muckle-Wells Syndrome (MWS)
- Recurrent Pericarditis
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2024/10/28 | Phase 2 | Recruiting | |||
2019/06/10 | Phase 2 | Completed | |||
2018/11/09 | Phase 3 | Completed | |||
2016/07/11 | Early Phase 1 | UNKNOWN | Stanley Cohen | ||
2014/06/24 | Phase 2 | Completed | |||
2013/07/19 | Phase 2 | Completed | |||
2013/04/12 | Not Applicable | Completed | Keesler Air Force Base Medical Center | ||
2013/03/04 | Phase 1 | Completed | |||
2013/02/28 | Phase 2 | Completed | National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) | ||
2012/08/13 | Phase 4 | Completed |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Kiniksa Pharmaceuticals (UK), Ltd. | 73604-914 | SUBCUTANEOUS | 160 mg in 2 mL | 5/8/2023 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
| No EMA approvals found for this drug. | |||
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 |
|---|---|---|---|---|---|
| Rilonacept for injection | 国药准字SJ20240045 | 生物制品 | 注射剂 | 11/22/2024 |
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 |
|---|---|---|---|---|---|
| No TGA approvals found for this drug. | |||||