Drugs / imdevimab
Regulatory milestones approvals, filings & regulatory actions · 2 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Withdrawn | EU (EMA) | Ronapreve | — | 2025-12-05 | europa.eu ↗ |
| Approved | EU (EMA) | Ronapreve | — | 2021-11-12 | europa.eu ↗ |
Trials 16 · a red edge is where a trial was stopped
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 14 trials | ||||||
| Phase 1 | NCT05181683 | Jan → Jun 2022 | — | Regeneron Pharmaceuticals | Completed | No outcome recorded |
| Phase 1 | NCT05157997 | Jan 2022 → Jan 2024 | COVID-19 | Northwell Health | Withdrawn | No outcome recorded |
| Phase 1 | NCT05092581 | Dec 2021 → Jun 2022 | COVID-19 | Regeneron Pharmaceuticals | Terminated | No outcome recorded |
| Phase 1 | NCT04519437 | Jul 2020 → Nov 2021 | — | Regeneron Pharmaceuticals | Completed | No outcome recorded |
| Phase 1/22 trials | ||||||
| Phase 1/2 | NCT05081388 | Nov 2021 → Jun 2022 | COVID-19 | Regeneron Pharmaceuticals | Terminated | No outcome recorded |
| Phase 1/2 | NCT04426695 | Jun 2020 → May 2021 | COVID-19 | Regeneron Pharmaceuticals | Completed | No outcome recorded |
| Phase 24 trials | ||||||
| Phase 2 | NCT04992273 | Sep 2021 → Jun 2022 | COVID-19 | Regeneron Pharmaceuticals | Terminated | No outcome recorded |
| Phase 2 | NCT04852978 | Apr 2021 → Nov 2022 | — | Regeneron Pharmaceuticals | Completed | No outcome recorded |
| Phase 2 | NCT04666441 | Dec 2020 → Mar 2021 | COVID-19 | Regeneron Pharmaceuticals | Completed | No outcome recorded |
| Phase 2 | NCT04840459 | Nov 2020 → Dec 2022 | COVID-19 | Sohail Rao | Unknown | No outcome recorded |
| Phase 33 trials | ||||||
| Phase 3 | NCT05074433 | Oct 2021 → May 2022 | immunodeficiency disease | Regeneron Pharmaceuticals | Terminated | No outcome recorded |
| Phase 3 | NCT04452318 | Jul 2020 → Oct 2021 | — | Regeneron Pharmaceuticals | Completed | No outcome recorded |
| Phase 3 | NCT04425629 | Jun 2020 → Jan 2022 | COVID-19 | Regeneron Pharmaceuticals | Terminated | No outcome recorded |
| Phase 42 trials | ||||||
| Phase 4 | NCT05502081 | Sep → Dec 2022 | COVID-19 | Mansoura University Hospital | Completed | No outcome recorded |
| Phase 4 | NCT04790786 | Mar 2021 → Jun 2022 | COVID-19 | Erin McCreary | Terminated | No outcome recorded |
| Phase not stated1 trial | ||||||
| — | NCT04617535 | — | COVID-19 | Regeneron Pharmaceuticals | No longer available | No outcome recorded |
Also used as a comparator or background therapy in 6 trials
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT04790240 Comparator | Jan 2025 → Dec 2026 expected | COVID-19 | All Natural Medicine Clinic, LLC | Recruiting | No outcome recorded |
| Phase 21 trial | ||||||
| Phase 2 | NCT05041907 Comparator | Sep 2021 → Jan 2027 expected | COVID-19 | University of Oxford | Recruiting | No outcome recorded |
| Phase 2/31 trial | ||||||
| Phase 2/3 | NCT04518410 Comparator | Aug 2020 → Apr 2022 | COVID-19 | National Institute of Allergy and Infectious Diseases (NIAID) | Completed | No outcome recorded |
| Phase 33 trials | ||||||
| Phase 3 | NCT05271929 Background | Apr 2022 → Jan 2024 | COVID-19 | German Red Cross Blood Transfusion Service Baden-Württemberg-Hessen | Terminated | No outcome recorded |
| Phase 3 | NCT05205759 Comparator | Dec 2021 → Feb 2022 | COVID-19 | Azienda Ospedaliera Universitaria Integrata Verona | Terminated | No outcome recorded |
| Phase 3 | NCT04381936 Comparator | Mar 2020 → Sep 2028 expected | pneumonia | University of Oxford | Recruiting | No outcome recorded |
Press releases naming this drug 26 releases
| Date | Issuer | Release |
|---|---|---|
| 2022-04-14 | Regeneron Pharmaceuticals | U.S. FDA Extends Review of Biologics License Application for REGEN-COV® (casirivimab and imdevimab) for Treatment and Prophylaxis of COVID-19 regeneron.com ↗ |
| 2021-11-08 | Regeneron Pharmaceuticals | New Phase 3 Analyses Show That a Single Dose of REGEN-COV® (casirivimab and imdevimab) Provides Long-term Protection Against COVID-19 regeneron.com ↗ |
| 2021-10-14 | Regeneron Pharmaceuticals | FDA Accepts REGEN-COV® (casirivimab and imdevimab) for Priority Review for Treatment and Prophylaxis of COVID-19 regeneron.com ↗ |
| 2021-09-30 | Roche Global Development | Phase II/III trial shows Ronapreve™ (casirivimab and imdevimab) significantly reduces viral load within seven days of treatment in patients hospitalised with COVID-19 roche.com ↗ |
| 2021-09-30 | Regeneron Pharmaceuticals | New REGEN-COV™ (casirivimab and imdevimab) Data Show Supportive Results in Patients Hospitalized with COVID-19 regeneron.com ↗ |
| 2021-09-29 | Regeneron Pharmaceuticals | New England Journal of Medicine Publishes Positive Phase 3 Trial Results for REGEN-COV™ (casirivimab and imdevimab) to Treat COVID-19 regeneron.com ↗ |
| 2021-09-14 | Regeneron Pharmaceuticals | Regeneron Announces New U.S. Government Agreement to Purchase Additional Doses of REGEN-COV™ (casirivimab and imdevimab) Antibody Cocktail regeneron.com ↗ |
| 2021-08-04 | Regeneron Pharmaceuticals | New England Journal of Medicine Publishes Positive Phase 3 Trial Results for REGEN-COV™ (casirivimab and imdevimab) to Prevent SARS-CoV-2 Infection regeneron.com ↗ |
| 2021-07-30 | Regeneron Pharmaceuticals | FDA Expands Authorized Use of REGEN-COV™ (casirivimab and imdevimab) regeneron.com ↗ |
| 2021-07-20 | Roche Global Development | Japan becomes first country to approve Ronapreve (casirivimab and imdevimab) for the treatment of mild to moderate COVID-19 roche.com ↗ |
| 2021-07-20 | Regeneron Pharmaceuticals | Japan Becomes First Country to Approve Regeneron Antibody Cocktail (casirivimab and imdevimab) for the Treatment of Mild to Moderate COVID-19 regeneron.com ↗ |
| 2021-06-16 | Regeneron Pharmaceuticals | REGEN-COV™ (casirivimab and imdevimab) Phase 3 RECOVERY Trial Meets Primary Outcome, Improving Survival in Hospitalized COVID-19 Patients Lacking an Immune Response to SARS-CoV-2 regeneron.com ↗ |
| 2021-06-04 | Regeneron Pharmaceuticals | FDA Authorizes Lower 1,200 mg Intravenous and Subcutaneous Dose of REGEN-COV™ (casirivimab and imdevimab) Antibody Cocktail to Treat Patients with COVID-19 regeneron.com ↗ |
| 2021-05-17 | Regeneron Pharmaceuticals | Phase 3 Data Presented at ATS 2021 Show REGEN-COV™ (casirivimab with imdevimab) Reduced Risk of Hospitalization or Death by 70% in Non-hospitalized COVID-19 Patients regeneron.com ↗ |
| 2021-05-03 | Regeneron Pharmaceuticals | ATS 2021 Breaking News Session to Feature Pivotal Data on REGEN-COV™ (casirivimab with imdevimab) and Dupixent® (dupilumab) regeneron.com ↗ |
| 2021-04-12 | Roche Global Development | Phase III prevention trial showed subcutaneous administration of investigational antibody cocktail casirivimab and imdevimab reduced risk of symptomatic COVID-19 infections by 81% roche.com ↗ |
| 2021-04-12 | Regeneron Pharmaceuticals | Phase 3 Treatment Trial in Recently Infected Asymptomatic Patients Showed REGEN-COV™ (casirivimab with imdevimab) Significantly Reduced Progression to Symptomatic COVID-19 regeneron.com ↗ |
| 2021-04-12 | Regeneron Pharmaceuticals | Phase 3 Prevention Trial Showed 81% Reduced Risk of Symptomatic SARS-CoV-2 Infections with Subcutaneous Administration of REGEN-COV™ (casirivimab with imdevimab) regeneron.com ↗ |
| 2021-04-09 | Regeneron Pharmaceuticals | NIH COVID-19 Treatment Guidelines Strongly Recommend Use of REGEN-COV™ (casirivimab with imdevimab) in Outpatients at High Risk of Clinical Progression regeneron.com ↗ |
| 2021-03-23 | Roche Global Development | New phase III data shows investigational antibody cocktail casirivimab and imdevimab reduced hospitalisation or death by 70% in non-hospitalised patients with COVID-19 roche.com ↗ |
| 2021-03-23 | Regeneron Pharmaceuticals | Phase 3 Trial Shows REGEN-COV™ (casirivimab with imdevimab) Antibody Cocktail Reduced Hospitalization or Death by 70% in Non-hospitalized COVID-19 Patients regeneron.com ↗ |
| 2021-02-26 | Roche Global Development | EMA issues advice on casirivimab and imdevimab antibody cocktail for the treatment of mild-to-moderate COVID-19 roche.com ↗ |
| 2021-02-26 | Regeneron Pharmaceuticals | EMA Issues Advice on Regeneron's Antibody Cocktail (casirivimab with imdevimab) for Certain COVID-19 Patients regeneron.com ↗ |
| 2021-02-25 | Regeneron Pharmaceuticals | Independent Data Monitoring Committee Finds Clear Efficacy for REGEN-COV™ (casirivimab with imdevimab) in Phase 3 COVID-19 Outpatient Outcomes Trial regeneron.com ↗ |
| 2021-01-12 | Roche Global Development | Roche confirms US government agreement to purchase additional doses of Regeneron’s casirivimab and imdevimab roche.com ↗ |
| 2020-11-21 | Regeneron Pharmaceuticals | Regeneron’s Casirivimab and Imdevimab Antibody Cocktail for COVID-19 is First Combination Therapy to Receive FDA Emergency Use Authorization regeneron.com ↗ |
Evidence & citations 5 cited values
Every value below carries the sentence it was read from. 22 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | imdevimab | “REGEN-COV (previously known as REGN-COV2), a combination of the monoclonal antibodies casirivimab and imdevimab, has been shown to markedly reduce the risk of hospitalization...” PMID 34347950 ↗ Aug 202119“Therefore, we performed a study to determine if the monoclonal antibody combination of casirivimab and imdevimab (CAS + IMD) can decrease the amount of virus in the nose of...” PMID 35895508 ↗ Dec 2022 “remdesivir (Veklury), Colchicine, anti-SARS-CoV-2 monoclonal antibodies, bamlanivimab, Casirivimab \& Imdevimab.” NCT04790240 ↗ “All casirivimab and imdevimab treatments showed significant virologic reduction through day 7.” PMID 35969402 ↗ Aug 2022 “casirivimab 4 g and imdevimab 4 g administered together in a single intravenous infusion” PMID 35151397 ↗ Feb 2022 “Monoclonal antibodies: 600mg casirivimab/ 600mg imdevimab given once on D0” NCT05041907 ↗ “Imdevimab” NCT05271929 ↗ |
| Known as | REGN10987 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT04519437 ↗ |
| Action | Inhibit | “blocking viral entry into host cells” PMID 35151397 ↗ Feb 2022 |
| Modality | Monoclonal antibody | “Casirivimab and imdevimab are non-competing monoclonal antibodies” PMID 35151397 ↗ Feb 2022 |
| Route | Intravenous | “administered together in a single intravenous infusion” PMID 35151397 ↗ Feb 2022 |