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.
Product | Developer | Therapeutic class/drug type | Development stage at time of guidance |
---|---|---|---|
A64-DP | BCN Peptides SA | Immunomodulator | Non-clinical phase |
Acalabrutinib | Acerta Pharma BV | Immunomodulator | Clinical phase |
Ad26.COV2.S | Janssen-Cilag International N.V. | Vaccine | Non-clinical phase |
Ad5-nCoV vaccine | Cansino Biotech | Vaccine | Clinical phase |
Adjuvanted whole virion inactivated vaccine | Sinovac Biotech Ltd | Vaccine | Non-clinical phase |
Anti-SARS-CoV-2 polyclonal hyperimmune immunoglobulin | Alliance hyperimmune project (Biotest AG, Bio Products Laboratory, LFB, Octapharma, CSL Behring and Takeda) | Antiviral | Clinical phase |
APN01 | Apeiron Biologics | Immunomodulator | Clinical phase |
Apremilast | Amgen Europe BV | Immunomodulator | Clinical phase |
AZD7442 | AstraZeneca | Antiviral (monoclonal antibody) | Non-clinical phase |
Baricitinib | Eli Lilly | Immunomodulator | Clinical phase |
CD24Fc | Oncoimmune Inc | Immunomodulator | Clinical phase |
ChAdOx1-SARS-CoV-2 | Vaccitech/AstraZeneca | Vaccine | Clinical phase |
CHAG-COVID19-CA | ChimAgents | Challenge agent for human infection models | Non-clinical phase |
Chloroquine | Oxford University | Other therapeutics | Clinical phase |
Chloroquine and hydroxychloroquine cyclops DPI | PureIMS | Other therapeutics | Clinical phase |
Copper chloride | ACOM | Antiviral | Clinical phase |
Coronavirus-like particle (COVLP) | Medicago | Vaccine | Non-clinical phase |
CT-P59 | Celltrion | Antiviral (monoclonal antibody) | Non-clinical phase |
CVnCoV, CV07050101 vaccine | Curevac | Vaccine | Non-clinical phase |
Danoprevir | Ascletis Pharmaceuticals Co Ltd | Antiviral | Clinical phase |
Eculizumab | Alexion | Immunomodulator | Clinical phase |
Emapalumab and anakinra | Swedish Orphan Biovitrum AB (SOBI) | Immunomodulator | Clinical phase |
FAV00B | Farmak International Holding GmbH | Antiviral | Non-clinical phase |
Favipiravir | Glenmark Pharmaceuticals Ltd | Antiviral | Clinical phase |
Gimsilumab | Roivant | Immunomodulator | Clinical phase |
Herpes simplex virus vector tetravalent SARS-CoV-2 vaccine | Krystal Bio | Vaccine | Non-clinical phase |
Kamada Anti-SARS-CoV-2 | Kamada Ireland Ltd | Immunoglobulin | Non-clinical phase |
Larifan Plus | Auramed Ltd | Antiviral | Non-clinical phase |
LNP-saRNA CoVid19 vaccine | VacEquity Global Health/Imperial College London | Vaccine | Clinical phase |
LUNAR-COV19 mRNA vaccine | Arcturus Therapeutics | Vaccine | Clinical phase |
LY-CoV555 (LY3819253) and LY-CoV016 (LY3832479) | Lilly | Antiviral (monoclonal antibody) | Non-clinical phase |
M5049 | Merck Healthcare | Immunomodulator | Non-clinical phase |
Mavrilimumab | Kiniksa Pharmaceuticals | Immunomodulator | Clinical phase |
Meplazumab | Jiangsu Pacific Meinuoke Biopharmaceutical Co Ltd | Antiviral (monoclonal antibody) | Clinical phase |
MK-4482 | Ridgeback Biotherapeutics LP/Merck Sharp & Dohme (Europe) Inc | Antiviral | Non-clinical phase |
mRNA SARS-CoV-2 vaccine | Biontech | Vaccine | Non-clinical phase |
mRNA-1273 SARS-CoV-2 vaccine | Moderna | Vaccine | Non-clinical phase |
MV-SARS-CoV-2 vaccine | Themis Bioscience GmbH/MSD | Vaccine | Non-clinical phase |
NVX-CoV-2 rS | Novavax | Vaccine | Non-clinical phase |
Otilimab | GSK | Immunomodulator | Clinical phase |
PF-07304814 | Pfizer | Antiviral | Non-clinical phase |
Protein nanoparticle vaccine | Emergex Vaccines Holding Ltd | Vaccine | Non-clinical phase |
Raloxifene | Dompé | Antiviral | Non-clinical phase |
Ravulizumab | Alexion | Other therapeutics | Clinical phase |
RBT-9 | Renibus Therapeutics Inc | Antiviral | Clinical phase |
REGN10933, REGN10987, REGN10989 | Regeneron UK | Antiviral (monoclonal antibody) | Non-clinical phase |
Remdesivir | Gilead | Antiviral | Clinical phase |
RESP301 | Thirty Respiratory Limited (30 Technology) | Antiviral | Non-clinical phase |
rVSVΔG-SARS-CoV-2 live attenuated | MSD/IAVI | Vaccine | Non-clinical phase |
Sarilumab | Sanofi Aventis | Immunomodulator | Clinical phase |
SARS-CoV-2 DNA vaccine | Inovio | Vaccine | Non-clinical phase |
SARS-Cov-2 vaccine | Queensland University/Seqirus | Vaccine | Non-clinical phase |
SARS-CoV-2 vaccine recombinant, adjuvanted | Sanofi Pasteur | Vaccine | Non-clinical phase |
Siltuximab | EUSApharma | Immunomodulator | Clinical phase |
S-trimer subunit vaccine | Clover Biopharma | Vaccine | Clinical phase |
Subunit vaccine adjuvanted | Medigen | Vaccine | Non-clinical phase |
Tocilizumab | Roche | Immunomodulator | Clinical phase |
UNI911 | Union Therapeutics | Antiviral | Clinical phase |
VIR-7831, VIR-7832 | Vir Biotechnology/GSK | Antiviral (monoclonal antibody) | Clinical phase |
VLA 2001 vaccine | Valneva | Vaccine | Non-clinical phase |
SNG001 | Synairgen Research Limited | Immunomodulator | Clinical phase |
VRP-033 | Venus Pharma GmbH | Immunomodulator | Non-clinical phase |
BRII-196, BRII-198 | Brii Biosciences | Antiviral (monoclonal antibody) | Non-clinical phase |
SCTA01 | Sinocelltech Ltd. | Antiviral (monoclonal antibody) | Clinical phase |
Itolizumab | Biocon Biologics Limited | Immunomodulator (monoclonal antibody) | Clinical phase |
Protein vaccine adjuvanted | Kentucky Bioprocessing, Inc | Vaccine | Non-clinical phase |
BI 764198 | Boehringer Ingelheim International GmbH | Other therapeutic | Clinical phase |
DNA Plasmid vaccine | Takis S.r.l., Rottapham Biotech | Vaccine | Non-clinical phase |
4P021 | 4P-Pharma | Antiviral | Non-clinical phase |
Masitinib mesylate | AB Science | Antiviral | Non-clinical phase |
EX-14870 | Boehringer Ingelheim International BmBH | Antiviral | Non-clinical phase |
2Deo | Dermin Sp. Z.0.0 | Other therapeutic | Non- Clinical Phase |
Emiplacel | Biopharma Excellence GmbH | Other therapeutic | Clinical Phase |
AT-527 | Roche | Antiviral | Clinical phase |
ABBV-47D11 | AbbVie | Antiviral | Clinical phase |
AR-711 | Aridis Pharmaceuticals Inc. | Antiviral | Non-clinical phase |
Aviptadil | Relief Therapeutics Holding S.A | Other therapeutics | Clinical Phase |
Acalabrutinib | AstraZeneca | Immunomodulator | Clinical Phase |
AR-711 | Aridis Pharmaceuticals, Inc. | Antiviral (monoclonal antibody) | Non-clinical phase |
Gam-COVID-Vac | The Gamaleya National Centre of Epidemiology and microbiology | Vaccine | Clinical Phase |
mRNA vaccine | Valneva | Vaccine | Non-clinical |
MRT550 mRNA vaccine | Sanofi | Vaccine | Non-clinical |
This information should not be read as an endorsement of any medicine.
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 II to phase IV adult clinical trials where the investigator sites are in the EEA;
- any clinical trials in children with investigator sites in the EU and any trials that form part of a paediatric investigation plan, including those where the investigator sites are outside the EU.
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.
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.