Inclisiran
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| Routes of administration | Subcutaneous injection |
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| Formula | C520H679F21N175O309P43S6 |
| Molar mass | 16248.27 g·mol−1 |
Inclisiran (development codes ALN-PCSsc, ALN-60212) is an experimental drug for the treatment of patients with atherosclerotic cardiovascular disease (ASCVD), ASCVD risk equivalents and heterozygous familial hypercholesterolemia (HeFH). It is a small interfering RNA that inhibits translation of the protein PCSK9.[1][2][3] It is being developed by The Medicines Company which licensed the rights to inclisiran from Alnylam Pharmaceuticals.[4]
In 2019 The Medicines Company announced positive results from pivotal phase III study (all primary and secondary endpoints were met with efficacy consistent with Phase I and II studies). The company anticipates regulatory submissions in the U.S. in the fourth quarter of 2019, and in Europe in the first quarter of 2020.[5] The Medicines Company is being acquired by Novartis.[6]
See also
- Hypercholesterolemia (elevated cholesterol)
References
- ^ Fitzgerald K, White S, Borodovsky A, Bettencourt BR, Strahs A, Clausen V, et al. (January 2017). "A Highly Durable RNAi Therapeutic Inhibitor of PCSK9". The New England Journal of Medicine. 376 (1): 41–51. doi:10.1056/NEJMoa1609243. PMC 5778873. PMID 27959715.
- ^ Spreitzer H (11 September 2017). "Neue Wirkstoffe: Inclisiran". Österreichische Apotheker-Zeitung (in German) (19/2017).
- ^ "Proposed INN: List 114" (PDF). WHO Drug Information. 29 (4). WHO: 531f. 2015.
- ^ Taylor, Nick Paul (26 August 2019). "Medicines Company's PCSK9 drug hits phase 3 efficacy goals". FierceBiotech.
{{cite web}}: Unknown parameter|name-list-format=ignored (|name-list-style=suggested) (help) - ^ "The Medicines Company Announces Positive Topline Results from First Pivotal Phase 3 Trial of Inclisiran". The Medicines Company. Retrieved 29 August 2019.
- ^ "Novartis acquires medicines company". Novartis. Retrieved 15 January 2020.
Further reading
- Ray KK, Landmesser U, Leiter LA, et al. (April 2017). "Inclisiran in Patients at High Cardiovascular Risk with Elevated LDL Cholesterol" (PDF). N. Engl. J. Med. 376 (15): 1430–1440. doi:10.1056/NEJMoa1615758. PMID 28306389.
- Ray KK, Wright RS, Kallend D, et al. (March 2020). "Two Phase 3 Trials of Inclisiran in Patients with Elevated LDL Cholesterol". N. Engl. J. Med. doi:10.1056/NEJMoa1912387. PMID 32187462.
External links
- "Inclisiran". Drug Information Portal. U.S. National Library of Medicine.
- Clinical trial number NCT03399370 for "Inclisiran for Participants With Atherosclerotic Cardiovascular Disease and Elevated Low-density Lipoprotein Cholesterol (ORION-10)" at ClinicalTrials.gov
- Clinical trial number NCT03400800 for "Inclisiran for Subjects With ACSVD or ACSVD-Risk Equivalents and Elevated Low-density Lipoprotein Cholesterol (ORION-11)" at ClinicalTrials.gov
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