COVID-19

Treatments and vaccines for COVID-19: research and development

The European Medicines Agency (EMA) is interacting with developers of potential COVID-19 treatments and vaccines to enable promising medicines to reach patients in the European Union (EU) as soon as possible.

EMA is providing guidance to assist developers of potential COVID-19 medicines to prepare for eventual applications for marketing authorisation

This includes scientific advice and as informal consultation with the COVID-19 EMA pandemic Task Force (COVID-ETF).

The outcome of any consultation or advice from EMA is not binding on developers.

COVID-19 medicines that have received EMA advice

ProductDeveloperTherapeutic class/drug typeDevelopment stage at time of guidance
A64-DPBCN Peptides SAImmunomodulatorNon-clinical phase
AcalabrutinibAcerta Pharma BVImmunomodulatorClinical phase
Ad26.COV2.SJanssen-Cilag International N.V.VaccineNon-clinical phase
Ad5-nCoV vaccineCansino BiotechVaccineClinical phase
Adjuvanted whole virion inactivated vaccineSinovac Biotech LtdVaccineNon-clinical phase
Anti-SARS-CoV-2 polyclonal hyperimmune immunoglobulinAlliance hyperimmune project (Biotest AG, Bio Products Laboratory, LFB, Octapharma, CSL Behring and Takeda)AntiviralClinical phase
APN01Apeiron BiologicsImmunomodulatorClinical phase
ApremilastAmgen Europe BVImmunomodulatorClinical phase
AZD7442AstraZenecaAntiviral (monoclonal antibody)Non-clinical phase
BaricitinibEli LillyImmunomodulatorClinical phase
CD24FcOncoimmune IncImmunomodulatorClinical phase
ChAdOx1-SARS-CoV-2Vaccitech/AstraZenecaVaccineClinical phase
CHAG-COVID19-CAChimAgentsChallenge agent for human infection modelsNon-clinical phase
ChloroquineOxford UniversityOther therapeuticsClinical phase
Chloroquine and hydroxychloroquine cyclops DPIPureIMSOther therapeuticsClinical phase
Copper chlorideACOM srlAntiviralClinical phase
Coronavirus-like particle (COVLP)MedicagoVaccineNon-clinical phase
CT-P59CelltrionAntiviral (monoclonal antibody)Non-clinical phase
CVnCoV, CV07050101 vaccineCurevacVaccineNon-clinical phase
DanoprevirAscletis Pharmaceuticals Co LtdAntiviralClinical phase
EculizumabAlexion

Immunomodulator

Clinical phase
Emapalumab and anakinraSwedish Orphan Biovitrum AB (SOBI)ImmunomodulatorClinical phase
FAV00BFarmak International Holding GmbHAntiviralNon-clinical phase
FavipiravirGlenmark Pharmaceuticals LtdAntiviralClinical phase
GimsilumabRoivantImmunomodulatorClinical phase
Herpes simplex virus vector tetravalent SARS-CoV-2 vaccineKrystal BioVaccineNon-clinical phase
Kamada Anti-SARS-CoV-2Kamada Ireland LtdImmunoglobulinNon-clinical phase
Larifan Plus

Auramed Ltd

AntiviralNon-clinical phase
LNP-saRNA CoVid19 vaccineVacEquity Global Health/Imperial College LondonVaccineClinical phase
LUNAR-COV19 mRNA vaccineArcturus TherapeuticsVaccineClinical phase
LY-CoV555 (LY3819253) and LY-CoV016 (LY3832479)LillyAntiviral (monoclonal antibody)Non-clinical phase
M5049Merck HealthcareImmunomodulatorNon-clinical phase
MavrilimumabKiniksa PharmaceuticalsImmunomodulatorClinical phase
MeplazumabJiangsu Pacific Meinuoke Biopharmaceutical Co LtdAntiviral (monoclonal antibody)Clinical phase
MK-4482Ridgeback Biotherapeutics LP/Merck Sharp & Dohme (Europe) IncAntiviralNon-clinical phase
mRNA SARS-CoV-2 vaccineBiontechVaccineNon-clinical phase
mRNA-1273 SARS-CoV-2 vaccineModernaVaccineNon-clinical phase
MV-SARS-CoV-2 vaccineThemis Bioscience GmbH/MSDVaccineNon-clinical phase
NVX-CoV-2 rSNovavaxVaccineNon-clinical phase
OtilimabGSKImmunomodulatorClinical phase
PF-07304814PfizerAntiviralNon-clinical phase
Protein nanoparticle vaccineEmergex Vaccines Holding LtdVaccineNon-clinical phase
RaloxifeneDompéAntiviralNon-clinical phase
RavulizumabAlexionOther therapeuticsClinical phase
RBT-9Renibus Therapeutics IncAntiviralClinical phase
REGN10933, REGN10987, REGN10989Regeneron UKAntiviral (monoclonal antibody)Non-clinical phase
RemdesivirGileadAntiviralClinical phase
RESP301Thirty Respiratory Limited (30 Technology)AntiviralNon-clinical phase
RGB-22Gedeon Richter Plc HungaryAntiviralNon-clinical phase
rVSVΔG-SARS-CoV-2 live attenuatedMSD/IAVIVaccineNon-clinical phase
SarilumabSanofi AventisImmunomodulatorClinical phase
SARS-CoV-2 DNA vaccineInovioVaccineNon-clinical phase
SARS-Cov-2 vaccineQueensland University/SeqirusVaccineNon-clinical phase
SARS-CoV-2 vaccine recombinant, adjuvantedSanofi PasteurVaccineNon-clinical phase
SiltuximabEUSApharmaImmunomodulatorClinical phase
SNG-001SynargeinImmunomodulatorClinical phase
S-trimer subunit vaccineClover BiopharmaVaccineClinical phase
Subunit vaccine adjuvantedMedigenVaccineNon-clinical phase
TocilizumabRocheImmunomodulatorClinical phase
UNI911Union TherapeuticsAntiviralClinical phase
VIR-7831, VIR-7832Vir Biotechnology/GSKAntiviral (monoclonal antibody)Clinical phase
VLA 2001 vaccineValnevaVaccineNon-clinical phase
VRP-033Venus Pharma GmbHImmunomodulatorNon-clinical phase
BRII-196, BRII-198Brii BiosciencesAntiviral (monoclonal antibody)Non-clinical phase
SCTA01Sinocelltech Ltd.Antiviral (monoclonal antibody)Clinical phase
Itolizumab (Bmab 600)Biocon Biologics LimitedImmunomodulator (monoclonal antibody)Clinical phase
TAP-COVID-19Kentucky Bioprocessing, IncVaccineNon-clinical phase
BI 764198Boehringer Ingelheim International GmbHOther therapeuticClinical phase
COVID-eVaxTakis S.r.l., Rottapham BiotechVaccineNon-clinical phase
Nitric Oxide (RESP301)Thirty Respiratory Limited (30 Technology)AntiviralClinical phase
4P0214P-PharmaAntiviralNon-clinical phase
 
Last updated 26 November 2020.

This information should not be read as an endorsement of any medicine.

Ongoing clinical trials in the EU

Information on ongoing COVID-19 clinical trials in the European Economic Area (EEA) is available in the EU Clinical Trials Register (EU CTR):

Users can find information on:

Phase I clinical trials conducted solely in adults are not made publicly available in the EU CTR.

For more information on the EU CTR and how clinical trials are authorised and overseen in the EEA, see Clinical trials in human medicines.

Global cooperation

Medicine regulatory authorities worldwide are also cooperating under the umbrella of the International Coalition of Medicines Regulatory Authorities (ICMRA) to expedite and streamline the development of COVID-19 vaccines and treatments.

For more information, see ICMRA: Cooperation to support the development of COVID-19 vaccines and treatments.

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