Drugs / regdanvimab
regdanvimab
Regulatory milestones approvals, filings & regulatory actions · 3 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed COVID-19 1 milestone | |||||
| Filed | EU (EMA) | — | COVID-19 | 2021-09-23 | “Celltrion Group today announced it has submitted a Marketing Authorisation Application (MAA) to the European Medicines Agency (EMA) seeking approval of regdanvimab (CT-P59)” celltrion.com ↗ “Celltrion submits Marketing Authorisation Application to the European Medicines Agency for regdanvimab (CT-P59)” celltrion.com ↗ |
| Withdrawn Indication not stated 2 milestones | |||||
| Withdrawn | EU (EMA) | Regkirona | — | 2025-04-14 | europa.eu ↗ |
| Approved | EU (EMA) | Regkirona | — | 2021-11-12 | europa.eu ↗ |
Trials 3
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 12 trials | ||||||
| Phase 1 | NCT04593641 | Sep → Oct 2020 | COVID-19 | Celltrion | Completed | No outcome recorded |
| Phase 1 | NCT04525079 | Jul → Aug 2020 | COVID-19 | Celltrion | Completed | No outcome recorded |
| Phase 2/31 trial · 1 met primary | ||||||
| Phase 2/3 | NCT04602000 | Oct 2020 → May 2021 | COVID-19 | Celltrion | Completed | Met primary |
| Comparator or background therapy1 trial | ||||||
| Phase 4 | NCT05982704 Comparator | Aug → Sep 2022 | COVID-19 | City Clinical Hospital No.52 of Moscow Healthcare Department | Unknown | No outcome recorded |
News releases announcing trial results or a regulatory action · 26
| Date | Issuer | Release |
|---|---|---|
| 2022-02-07 | Celltrion | Regulatory Celltrion Submits IND Application to Initiate a Global Phase III Clinical Trial Evaluating an Inhaled COVID-19 Antibody Cocktail Therapy celltrion.com ↗
Celltrion submitted an IND application for a global Phase III clinical trial of inhaled antibody cocktail therapy with CT-P59 and CT-P63; the company expects to enrol 2,200 patients with mild-to-moderate symptoms of COVID-19 |
| 2021-12-07 | Celltrion | Regulatory TGA grants provisional approval for Celltrion’s regdanvimab (regkirona) celltrion.com ↗
TGA grants provisional approval for Celltrion’s regdanvimab (regkirona) |
| 2021-11-15 | Celltrion | Regulatory Celltrion’s Monoclonal Antibody Treatment regdanvimab, Approved by the European Commission for the Treatment of COVID-19 celltrion.com ↗
Celltrion Group announced today that the European Commission (EC) has approved Regkirona (regdanvimab, CT-P59), one of the first monoclonal antibody treatments granted marketing authorisation from the European Medicines Agency (EMA). |
| 2021-11-12 | Celltrion | Regulatory Celltrion Receives CHMP Positive Opinion for regdanvimab (CT-P59) as One of the First Monoclonal Antibodies for COVID-19 by the CHMP celltrion.com ↗
The CHMP positive opinion marks the first time a monoclonal antibody treatment for COVID-19 has received a recommendation for marketing authorisation from the EMA |
| 2021-10-05 | Celltrion | Regulatory Celltrion submits Marketing Authorisation Application to the European Medicines Agency for regdanvimab (CT-P59) celltrion.com ↗
Celltrion Group today announced it has submitted a Marketing Authorisation Application (MAA) to the European Medicines Agency (EMA) seeking approval of regdanvimab (CT-P59), a monoclonal antibody treatment for COVID-19. |
| 2021-09-18 | Celltrion | Regulatory Celltrion’s regdanvimab (CT-P59) becomes the first authorized COVID-19 treatment approved from the Korean MFDS celltrion.com ↗
This marks the first time a monoclonal antibody treatment for COVID-19 has received a full approval to treat patients with COVID-19 from the Korean MFDS. |
| 2021-08-12 | Celltrion | Regulatory Brazilian Health Regulatory Agency (ANVISA) grants emergency use authorisation (EUA) for Celltrion’s regdanvimab (CT-P59) celltrion.com ↗ |
| 2021-08-02 | Dexa Medica Group | Results Regdanvimab Reduced The Risk of COVID-19-related Hospitalization or Death for Patients with Comorbidities dexagroup.com ↗
According to clinical studies, regdanvimab (RegkironaTM) significantly reduced the risk of COVID-19 related hospitalization or death by 72% for patients at high risk of progressing to severe COVID-19 by day 28. |
| 2021-07-16 | Celltrion | Results Celltrion’s monoclonal antibody treatment for COVID-19, regdanvimab (CT-P59), demonstrates strong neutralising activity against Delta variant celltrion.com ↗
Celltrion Group today announced new results from an in vivo efficacy study showing that regdanvimab (CT-P59) has a strong neutralising effect against the rapidly spreading Delta variant (B.1.617.2, first identified in India). |
| 2021-07-05 | Celltrion | Results Celltrion’s monoclonal antibody treatment for COVID-19, regdanvimab, demonstrates efficacy in neutralising against Gamma variant (P.1, Brazil variant) celltrion.com ↗
The study demonstrated that CT-P59 treatment results in a significant reduction in viral load from lungs and 100% survival rate from COVID-19 compared to placebo animal model of 0%. |
| 2021-06-14 | Celltrion | Results Celltrion announces positive top-line results from global Phase III trial of regdanvimab (CT-P59), an anti-COVID-19 monoclonal antibody treatment celltrion.com ↗
Celltrion Group today announced top-line efficacy and safety data from the global Phase III clinical trial, demonstrating that anti-COVID-19 monoclonal antibody treatment candidate, regdanvimab (CT-P59), met all primary and key secondary endpoints in patients with mild- to- moderate symptoms of COVID-19 (n=1,315). |
| 2021-05-18 | Celltrion | Results Celltrion Confirms Neutralising Potency Against Emerging SARS-CoV-2 Variants With Anti-COVID-19 Monoclonal Antibody Treatment regdanvimab (CT-P59) celltrion.com ↗
The monoclonal antibody candidate CT-P59 demonstrated strong neutralising capability against the New York (B.1.526) and Nigeria (B.1.525) variants and produced neutralising titers against the Indian variant (B.1.617) in an in-vitro pseudo virus assay. |
| 2021-04-29 | Celltrion | Results Celltrion’s anti-COVID 19 monoclonal antibody treatment, regdanvimab, demonstrates neutralising effect against the South African variant (B.1.351) celltrion.com ↗
Celltrion Group today announced preliminary pre-clinical results for regdanvimab (CT-P59), an anti-COVID-19 monoclonal antibody treatment, with data demonstrating that CT-P59 has a neutralising effect against the South African variant in an in vivo model. |
| 2021-03-26 | Celltrion | Regulatory EMA issues advice on the use of Celltrion’s anti-COVID-19 monoclonal antibody treatment regdanvimab (CT-P59) for COVID-19 patients in the European Uni celltrion.com ↗
Celltrion Group today announced the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive scientific opinion for the company’s anti-COVID-19 monoclonal antibody treatment candidate, regdanvimab (CT-P59). |
| 2021-02-11 | Celltrion | Results Celltrion develops tailored neutralising antibody cocktail treatment with CT-P59 to tackle COVID-19 variant spread using its antibody development plat celltrion.com ↗
Celltrion Group today announced that CT-P59, an anti-COVID-19 monoclonal antibody treatment candidate, has confirmed neutralising potency against emerging virus mutations and that the company has initiated development of a neutralising antibody cocktail treatment with CT-P59. |
| 2021-02-11 | Celltrion | Results Celltrion Develops Tailored Neutralising Antibody Cocktail Treatment with CT-P59 to Tackle COVID-19 Variant Spread Using Its Antibody Development Plat celltrion.com ↗
The Korea Disease Control and Prevention Agency (KDCA) has assessed and independently confirmed that CT-P59 successfully neutralises the SARS-CoV-2 variants first identified in the UK (B.1.1.7) in addition to the previously identified six variant genome mutations of SARS-CoV-2 (variants S·L·V·G·GH·GR). |
| 2021-02-05 | Celltrion | Regulatory Celltrion’s COVID-19 treatment candidate receives Korean MFDS Conditional Marketing Authorisation celltrion.com ↗
Celltrion Group today announced that the Korean Ministry of Food and Drug Safety (MFDS) granted a Conditional Marketing Authorisation (CMA) for the emergency use of Regdanvimab (CT-P59), an anti-COVID-19 monoclonal antibody treatment candidate. |
| 2021-01-13 | Celltrion | Results Celltrion Group announces positive top-line efficacy and safety data from global Phase II/III clinical trial of COVID-19 treatment candidate CT-P59 celltrion.com ↗
When compared to placebo, CT-P59 (40mg/kg) treated patients reported reduced progression rates to severe COVID-19 by 54% for mild-to-moderate patients and 68% for moderate patients aged 50 years and over. |
| 2021-01-13 | Celltrion | Results Celltrion Group announces positive top-line efficacy and safety data from global Phase II/III clinical trial of COVID-19 treatment candidate CT-P59 celltrion.com ↗
Celltrion Group today announced top-line results from its randomised, double-blind, and placebo controlled global Phase II/III clinical trial of CT-P59, an anti-COVID-19 monoclonal antibody treatment candidate. |
| 2020-12-29 | Celltrion | Regulatory Celltrion submits application for Conditional Marketing Authorisation of its COVID-19 treatment candidate CT-P59 to the Korean MFDS celltrion.com ↗
Celltrion Group has submitted today a formal Application for Conditional Marketing Authorisation (CMA) to the Korean Ministry of Food and Drug Safety (MFDS). |
| 2020-12-29 | Celltrion | Regulatory Celltrion submits application for Conditional Marketing Authorisation of its COVID-19 treatment candidate CT-P59 to the Korean MFDS celltrion.com ↗
Celltrion Group has submitted today a formal Application for Conditional Marketing Authorisation (CMA) to the Korean Ministry of Food and Drug Safety (MFDS). |
| 2020-11-06 | Celltrion | Results Celltrion presents efficacy and safety data for potential COVID-19 treatment candidate CT-P59 in patients with mild symptoms celltrion.com ↗
The results indicate that the patient population treated with CT-P59 experienced about 44% reduced mean clinical recovery time in comparison to the average placebo recovery time. |
| 2020-09-17 | Celltrion | Regulatory Celltrion receives Korean MFDS approval to initiate Phase II/III pivotal trial of an anti-COVID-19 monoclonal antibody treatment candidate, CT-P59 celltrion.com ↗
Celltrion Group announced today that the Korean Ministry of Food and Drug Safety (MFDS) has approved the company’s Investigational New Drug (IND) application for a Phase II/III pivotal clinical trial of CT-P59, an anti-COVID-19 monoclonal antibody treatment candidate. |
| 2020-09-11 | Celltrion | Results Celltrion Announces Positive Interim Results From Phase I Trial of CT-P59, an Anti-COVID-19 Monoclonal Antibody Treatment Candidate celltrion.com ↗
Celltrion Group announced today interim results from the Phase I clinical trial of CT-P59, an anti-COVID-19 monoclonal antibody treatment candidate. |
| 2020-08-26 | Celltrion | Regulatory Celltrion receives Korean MFDS approval to initiate Phase I trial of COVID-19 antiviral antibody treatment candidate, CT-P59, in patients celltrion.com ↗
The Korean Ministry of Food and Drug Safety (MFDS) approved Celltrion’s Investigational New Drug (IND) application to initiate a Phase I trial of CT-P59 in patients |
| 2020-07-30 | Celltrion | Regulatory Celltrion receives MHRA approval to initiate Phase I trial of potential COVID-19 antiviral antibody treatment, CT-P59, in the UK celltrion.com ↗
The UK Medicines and Healthcare products Regulatory Agency (MHRA) approved Celltrion’s clinical trial authorization (CTA) application to initiate a Phase I trial of CT-P59, a potential COVID-19 antiviral antibody treatment |
All press releases naming this drug 29 releases
Evidence & citations 5 cited values
Every value below carries the sentence it was read from. 6 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | regdanvimab | “CT-P59 (regdanvimab), a SARS-CoV-2 neutralizing monoclonal antibody, was examined in 2 randomized, double-blind, placebo-controlled, single ascending dose, Phase I studies.” PMID 34551869 ↗ Aug 2021 |
| Known as | CT-P59 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT04525079 ↗ |
| Known as | Regkirona | ChEMBL registry synonym — accepted as the source's own label CHEMBL4650462 ↗ |
| Modality | Monoclonal antibody | “CT-P59 (regdanvimab), a SARS-CoV-2 neutralizing monoclonal antibody” PMID 34551869 ↗ Aug 2021 |
| Route | Intravenous | “CT-P59 (40 mg/kg) by IV infusion administered over 90 minutes, once (Part 1)” NCT04602000 ↗ |