Table 3.
All approved RNA therapies, including emergency authorizations for COVID-19 vaccines, as of June 2023
| Product name | Generic name | Originator company | Modality | Disease(s) | Year first approved | Locations approved |
|---|---|---|---|---|---|---|
| Qalsody | Tofersen | Ionis Pharmaceuticals | Antisense therapy | Amyotrophic lateral sclerosis | 2023 | USA |
| ARCT 154 | COVID-19 mRNA vaccine | Arcturus Therapeutics | mRNA vaccine | Infection, coronavirus, novel coronavirus prophylaxis | 2023 | Japan |
| Amvuttra | Vutrisiran | Alnylam | RNAi | Amyloidosis, TTR-related hereditary | 2022 | EU, USA, UK |
| ARCoV | COVID-19 mRNA vaccine | Suzhou Abogen Biosciences | mRNA vaccine | Infection, coronavirus, novel coronavirus prophylaxis | 2022 | Indonesia |
| Spikevax Bivalent Original/Omicron | Bivalent COVID-19 vaccine | Moderna | mRNA vaccine | Infection, coronavirus, novel coronavirus prophylaxis | 2022 | UK, Australia, EU, Canada, Japan, Singapore, South Korea, China, USA |
| COVID-19 vaccine | Bivalent COVID-19 vaccine | BioNTech | mRNA vaccine | Infection, coronavirus, novel coronavirus prophylaxis | 2022 | UK, USA |
| SYS6006; COVID-19 mRNA vaccine | CSPC Pharmaceutical | mRNA vaccine | Infection, coronavirus, novel coronavirus prophylaxis | 2022 | China | |
| Nulibry | Fosdenopterin | Orphatec | Oligonucleotide-derived therapy | Molybdenum cofactor deficiency | 2021 | USA, EU, Israel, UK |
| Gemcovac | COVID-19 mRNA vaccine | Emcure Pharmaceuticals | mRNA vaccine | Infection, coronavirus, novel coronavirus prophylaxis | 2021 | India |
| Comirnaty | Tozinameran | BioNTech | mRNA vaccine | Infection, coronavirus, novel coronavirus prophylaxis | 2020 | Australia, EU, Brazil, Canada, Ghana, Israel, Japan, Kuwait, Malaysia, Mexico, New Zealand, Rwanda, Singapore, South Africa, South Korea, UK, UAE, USA, China, Bahrain, Chile, Colombia, Indonesia, Oman, Sri Lanka, Thailand, Vietnam, Egypt, Indonesia |
| Oxlumo | Lumasiran | Alnylam | RNAi | Hyperoxaluria | 2020 | EU, USA, Brazil, UK |
| Leqvio | Inclisiran | Alnylam | RNAi | Atherosclerosis, heterozygous familial hypercholesterolaemia, hypercholesterolaemia | 2020 | EU, USA, Australia, UK |
| Amondys 45 | Casimersen | Sarepta Therapeutics | Antisense therapy | Dystrophy, Duchenne muscular | 2020 | USA |
| Spikevax | 2019-nCoV vaccine | Moderna | mRNA vaccine | Infection, coronavirus, novel coronavirus prophylaxis | 2020 | Canada, EU, Israel, Nigeria, UK, USA, Japan, South Korea, Australia, Botswana, Brunei, Indonesia, India, Vietnam, Thailand, China, Singapore, Saudi Arabia, Qatar, Paraguay, Mexico, Philippines |
| Waylivra | Volanesorsen | Ionis Pharmaceuticals | Antisense therapy | Hypertriglyceridaemia, lipoprotein lipase deficiency | 2019 | EU, UK, Brazil, Canada, |
| Viltepso | Viltolarsen | Nippon Shinyaku | Antisense therapy | Dystrophy, Duchenne muscular | 2019 | Japan, USA |
| Vyondys 53 | Golodirsen | Sarepta Therapeutics | Antisense therapy | Dystrophy, Duchenne muscular | 2019 | USA |
| Givlaari | Givosiran | Alnylam | RNAi | Porphyria | 2019 | Canada, EU, UK, USA, Israel, Brazil, Japan |
| Onpattro | Patisiran | Alnylam | RNAi | Amyloidosis, TTR-related hereditary | 2018 | EU, Canada, Israel, Japan, Brazil, USA, UK, China |
| Tegsedi | Inotersen | Ionis Pharmaceuticals | Antisense therapy | Amyloidosis, TTR-related hereditary | 2018 | EU, Canada, UK, USA, Brazil |
| Ampligen | Rintatolimod | AIM ImmunoTech | Mismatched double-stranded RNA | Chronic fatigue syndrome | 2016 | Argentina |
| Spinraza | Nusinersen | Ionis Pharmaceuticals | Antisense therapy | Muscular atrophy, spinal | 2016 | Australia, EU, USA, Canada, China, Israel, South Korea, UK, Japan, Argentina, Brazil, Colombia |
| Exondys 51 | Eteplirsen | Sarepta Therapeutics | Antisense therapy | Dystrophy, Duchenne muscular | 2016 | USA |
| Kynamro | Mipomersen sodium | Ionis Pharmaceuticals | Antisense therapy | Homozygous familial hypercholesterolaemia | 2013 | Argentina, South Korea, USA, Mexico |