Drugs / RTS,S
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed | EU (EMA) | — | malaria | 2014-07-24 | “GSK announced today that it has submitted a regulatory application to the European Medicines Agency (EMA) for its malaria vaccine candidate, RTS,S.” gsk.com ↗ “Submitting a regulatory application for our malaria vaccine candidate RTS,S.” gsk.com ↗ |
Trials 1
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 1/2 | NCT01556945 | Apr 2001 → Feb 2002 | Plasmodium falciparum malaria | U.S. Army Medical Research and Development Command | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 7
| Date | Issuer | Release |
|---|---|---|
| 2022-09-06 | GlaxoSmithKline | Regulatory WHO grants prequalification to GSK’s Mosquirix – the first and only approved malaria vaccine gsk.com ↗
GSK plc (LSE/NYSE: GSK) announced today that the World Health Organization (WHO) has awarded prequalification to Mosquirix (also known as RTS,S/AS01), GSK’s groundbreaking malaria vaccine. |
| 2021-10-06 | GlaxoSmithKline | Regulatory GSK welcomes WHO recommendation for broad roll-out of its RTS,S/AS01e (RTS,S) malaria vaccine gsk.com ↗
Based on the recommendation of its global advisory bodies for immunization and malaria, WHO has recommended the wider use of GSK’s RTS,S malaria vaccine in children living in sub-Saharan Africa and other regions with moderate to high malaria transmission. |
| 2015-07-24 | GlaxoSmithKline | Regulatory GSK’s malaria candidate vaccine, Mosquirix™ (RTS,S), receives positive opinion from European regulators for the prevention of malaria in young children in sub-Saharan Africa gsk.com ↗
The positive opinion for young children was based on the review of data assessing the candidate vaccine’s safety, efficacy and quality. |
| 2015-04-24 | GlaxoSmithKline | Results Malaria vaccine candidate has demonstrated efficacy over 3-4 years of follow-up gsk.com ↗
Final results from a large-scale Phase III trial of the RTS,S malaria vaccine candidate, including the impact of a booster dose, published today in The Lancet, show that the vaccine candidate helped protect children and infants from clinical malaria for at least three years after first vaccination. |
| 2014-07-24 | GlaxoSmithKline | Regulatory GSK announces EU regulatory submission for malaria vaccine candidate RTS,S gsk.com ↗
GSK announced today that it has submitted a regulatory application to the European Medicines Agency (EMA) for its malaria vaccine candidate, RTS,S. |
| 2013-10-08 | GlaxoSmithKline | Results Malaria vaccine candidate reduces disease over 18 months of follow-up in late-stage study of more than 15,000 infants and young children gsk.com ↗
Results from a large-scale Phase III trial, presented today in Durban, show that the most clinically advanced malaria vaccine candidate, RTS,S, continued to protect young children and infants from clinical malaria up to 18 months after vaccination. |
| 2011-10-18 | GlaxoSmithKline | Results First results from ongoing Phase III trial show malaria vaccine candidate, RTS,S* reduces the risk of malaria by half in African children aged 5 to 17 months gsk.com ↗
The trial, conducted at 11 trial sites in seven countries across sub-Saharan Africa, showed that three doses of RTS,S reduced the risk of children experiencing clinical malaria and severe malaria by 56% and 47%, respectively. |
All press releases naming this drug 9 releases
Evidence & citations 3 cited values
Every value below carries the sentence it was read from. 2 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | RTS,S | ClinicalTrials.gov intervention name — accepted as the source's own label NCT01556945 ↗ |
| Modality | Vaccine | “RTS,S malaria vaccine given with the adjuvant AS02” NCT01556945 ↗ |
| Route | Other | “intra-deltoid half-doses of RTS,S/AS02 and FMP1/AS02 administered” PMID 38584058 ↗ Apr 2024 |