Inotersen
- Generic Name
- Inotersen
- Brand Names
- Tegsedi
- Drug Type
- Biotech
- CAS Number
- 1492984-65-2
- Unique Ingredient Identifier
- 0IEO0F56LV
Overview
Inotersen is a transthyretin-directed antisense oligonucleotide for the treatment of the polyneuropathy caused by hereditary transthyretin-mediated amyloidosis in adults. It was FDA approved in October 2018. Inotersen has been shown to improve the course of neurologic disease and quality of life in patients with hereditary transthyretin amyloidosis . Hereditary transthyretin amyloidosis is caused by single-nucleotide variants in the gene encoding transthyretin (TTR), which lead to transthyretin misfolding and the deposition of amyloid substance systemically. Progressive amyloid accumulation may lead to multiorgan dysfunction and death .
Background
Inotersen is a transthyretin-directed antisense oligonucleotide for the treatment of the polyneuropathy caused by hereditary transthyretin-mediated amyloidosis in adults. It was FDA approved in October 2018. Inotersen has been shown to improve the course of neurologic disease and quality of life in patients with hereditary transthyretin amyloidosis . Hereditary transthyretin amyloidosis is caused by single-nucleotide variants in the gene encoding transthyretin (TTR), which lead to transthyretin misfolding and the deposition of amyloid substance systemically. Progressive amyloid accumulation may lead to multiorgan dysfunction and death .
Indication
Inotersen is a transthyretin-directed antisense oligonucleotide indicated for treatment of the polyneuropathy of hereditary transthyretin-mediated amyloidosis in adults.
Associated Conditions
- Hereditary Transthyretin Amyloidosis
- Polyneuropathies caused by Hereditary transthyretin-mediated amyloidosis
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2020/03/13 | Phase 4 | Terminated | |||
2020/02/17 | N/A | Recruiting | |||
2019/10/23 | Phase 3 | Completed | |||
2018/10/11 | Phase 2 | UNKNOWN | |||
2018/01/17 | N/A | APPROVED_FOR_MARKETING | |||
2014/06/26 | Phase 3 | Completed | |||
2012/11/29 | Phase 2 | Completed |
FDA Approved Products
Product Name | Manufacturer | Route | Strength | Approved | NDC Code |
|---|---|---|---|---|---|
Tegsedi | Akcea Therapeutics, Inc. | SUBCUTANEOUS | 284 mg in 1.5 mL | 2019/05/20 | 72126-007 |
EMA Approved Products
Medicine Name | EMA Number | Auth. Holder | Country | Drug Type | Status | Issued | Opinion | Revision |
|---|---|---|---|---|---|---|---|---|
Tegsedi | EMEA/H/C/004782 | Akcea Therapeutics Ireland Limited,St. James House,72 Adelaide Road,Dublin 2,D02 Y017,Ireland | Ireland | Orphan | Authorised | 2018/07/06 | 2018/05/30 | 15 |
Singapore Approved Products
Product Name | Manufacturer | Dosage Form | Strength | Approved | Approval No. | Online |
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No Singapore products found
No Singapore products found for this drug
China Approved Products
Product Name | Approval No. | Manufacturer | Dosage Form | Trade Name | Strength | Type | Status | Date | Import |
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No China products found
No China products found for this drug
Australia Approved Products
Product Name | ARTG ID | Sponsor | Status | Reg. Date | Ingredient |
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No Australia products found
No Australia products found for this drug