Drugs / QS-21
Regulatory milestones approvals, filings & regulatory actions · 3 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed | Japan (PMDA) | Shingrix | herpes zoster | 2017-05-04 | “GSK's shingles vaccine containing Agenus' QS-21 filed for regulatory approval in Japan” agenusbio.com ↗ |
| Filed | US (FDA) | Shingrix | herpes zoster | 2016-10-27 | “GlaxoSmithKline's Shingrix ® vaccine candidate containing Agenus' QS-21 Stimulon ® for prevention of shingles in adults aged 50 years or older, was filed for US regulatory approval.” agenusbio.com ↗ |
| Filed | EU (EMA) | Shingrix | herpes zoster | — | “GSK's shingles vaccine containing Agenus' QS-21 filed for regulatory approval in Japan in addition to existing filings for US, Canada and EU” agenusbio.com ↗ |
Trials 11
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 15 trials | ||||||
| Phase 1 | NCT06417853 | Jul 2024 → Jan 2026 | avian influenza | Vaxxas Pty Ltd | Completed | No outcome recorded |
| Phase 1 | NCT00005632 | Jun 1999 → Mar 2009 | prostate cancer | Memorial Sloan Kettering Cancer Center | Completed | No outcome recorded |
| Phase 1 | NCT00003224 | Feb 1996 → Aug 2000 | cutaneous melanoma | University of Virginia | Completed | No outcome recorded |
| Phase 1 | NCT00001044 | ? → May 1995 | HIV infectious disease | National Institute of Allergy and Infectious Diseases (NIAID) | Completed | No outcome recorded |
| Phase 1 | NCT00001096 | ? → Mar 2000 | HIV infectious disease | National Institute of Allergy and Infectious Diseases (NIAID) | Completed | No outcome recorded |
| Phase 24 trials · 1 met primary | ||||||
| Phase 2 | NCT01687595 | Oct 2012 → Sep 2013 | genital herpes simplex type 2 infectious disorder | Agenus Inc. | Completed | Met primary |
| Phase 2 | NCT00752232 | Dec 2008 → Jul 2012 | Alzheimer disease | Pfizer | Completed | No outcome recorded |
| Phase 2 | NCT00498602 | Nov 2007 → Feb 2013 | Alzheimer disease | Pfizer | Completed | No outcome recorded |
| Phase 2 | NCT00003362 | May 1998 → Feb 2001 | cutaneous melanoma | Memorial Sloan Kettering Cancer Center | Completed | No outcome recorded |
| Phase 31 trial · 1 missed | ||||||
| Phase 3 | NCT00005052 | Dec 1999 → ? | cutaneous melanoma | European Organisation for Research and Treatment of Cancer - EORTC | Unknown | Missed primary |
| Phase not applicable1 trial | ||||||
| — | NCT00470574 | Mar 2007 → Jan 2020 | breast cancer | Memorial Sloan Kettering Cancer Center | Completed | No outcome recorded |
| Comparator or background therapy24 trials | ||||||
| Phase 1 | NCT06741072 Background | Jun 2026 → Jul 2027 expected | Epstein-Barr virus-associated lymphoproliferative disorder, end stage renal failure, post-transplant lymphoproliferative disease | Ohio State University Comprehensive Cancer Center | Recruiting | No outcome recorded |
| Phase 1 | NCT03673020 Background | May 2019 → Feb 2021 | cancer | Agenus Inc. | Completed | No outcome recorded |
| Phase 1 | NCT02992977 Background | Jan 2017 → Dec 2018 | — | Agenus Inc. | Terminated | No outcome recorded |
| Phase 1 | NCT01248273 Background | Nov 2010 → Mar 2017 | fallopian tube disorder, ovarian cancer, peritoneum cancer | Memorial Sloan Kettering Cancer Center | Completed | No outcome recorded |
| Phase 1 | NCT00036933 Background | Mar 2002 → Mar 2009 | prostate cancer | Memorial Sloan Kettering Cancer Center | Completed | No outcome recorded |
| Phase 1 | NCT00006387 Background | Oct 2000 → Jan 2002 | colorectal cancer, malignant pancreatic neoplasm | Fox Chase Cancer Center | Completed | No outcome recorded |
| Phase 1 | NCT00006041 Background | Feb 2000 → Feb 2002 | fallopian tube cancer, ovarian cancer, primary peritoneal carcinoma | Memorial Sloan Kettering Cancer Center | Completed | No outcome recorded |
| Phase 1 | NCT00004929 Background | Sep 1999 → Jun 2008 | prostate cancer | Memorial Sloan Kettering Cancer Center | Completed | No outcome recorded |
| Phase 1 | NCT00004156 Background | May 1999 → Jun 2008 | breast cancer | Memorial Sloan Kettering Cancer Center | Completed | No outcome recorded |
| Phase 1 | NCT00003819 Background | Jun 1998 → Mar 2009 | prostate cancer | Memorial Sloan Kettering Cancer Center | Completed | No outcome recorded |
| Phase 1 | NCT00003357 Background | Jan 1998 → Nov 2001 | breast cancer | Memorial Sloan Kettering Cancer Center | Completed | No outcome recorded |
| Phase 1 | NCT00001572 Background | Jan 1997 → Jul 1999 | follicular lymphoma | National Cancer Institute (NCI) | Completed | No outcome recorded |
| Phase 1 | NCT00001052 Background | ? → Sep 1997 | HIV infectious disease | National Institute of Allergy and Infectious Diseases (NIAID) | Completed | No outcome recorded |
| Phase 1 | NCT00000809 Background | — | HIV infectious disease, seronegative autoimmune hepatitis | National Institute of Allergy and Infectious Diseases (NIAID) | Withdrawn | No outcome recorded |
| Phase 1/2 | NCT05841550 Background | May 2023 → May 2027 expected | smoldering plasma cell myeloma | Oslo University Hospital | Recruiting | No outcome recorded |
| Phase 2 | NCT05638698 Background | Dec 2022 → Dec 2024 overdue | neoplasm | University of Kansas Medical Center | Active not recruiting | No outcome recorded |
| Phase 2 | NCT01227564 Background | Feb 2011 → Feb 2014 | Alzheimer disease | Pfizer | Completed | Missed primary |
| Phase 2 | NCT00955409 Background | Nov 2009 → Dec 2013 | Alzheimer disease | Pfizer | Completed | No outcome recorded |
| Phase 2 | NCT00960531 Background | Jul 2009 → Dec 2013 | Alzheimer disease | Pfizer | Terminated | No outcome recorded |
| Phase 2 | NCT00479557 Comparator | May 2007 → Jan 2013 | Alzheimer disease | Pfizer | Completed | No outcome recorded |
| Phase 2 | NCT00579423 Background | Nov 2000 → May 2003 | cancer, prostate disorder | Memorial Sloan Kettering Cancer Center | Completed | No outcome recorded |
| Phase 2 | NCT00004052 Background | Mar 1999 → Aug 2005 | leukemia | Memorial Sloan Kettering Cancer Center | Completed | No outcome recorded |
| Phase 2 | NCT00004249 Background | Aug 1998 → Nov 2001 | small cell lung carcinoma | Memorial Sloan Kettering Cancer Center | Completed | No outcome recorded |
| — | NCT00030823 Background | Mar 2001 → Feb 2009 | breast cancer | Memorial Sloan Kettering Cancer Center | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 22
| Date | Issuer | Release |
|---|---|---|
| 2025-06-16 | Targovax Oy | Results TG01 mutant RAS cancer vaccine data showing clinical benefit in multiple myeloma presented at EHA 2025 circio.com ↗
TG01 vaccination led to an increase in mutant RAS T-cells in 6 patients; 5 of these patients remain on study with stable disease |
| 2023-12-07 | Targovax Oy | Results Circio announces completion of planned safety review and opening for full enrollment of TG01 study at Oslo University Hospital circio.com ↗
today announces that mutant RAS cancer vaccine TG01 adjuvanted by QS-21 STIMULON has passed the planned safety cohort review without any concerns in the multiple myeloma trial at Oslo University Hospital (OUS). |
| 2022-10-13 | Agenus Inc. | Results GSK’s older adult RSV vaccine candidate, containing Agenus’ QS-21 STIMULON™, shows 94.1% reduction in severe RSV disease and overall vaccine efficacy of 82.6% in pivotal trial agenusbio.com ↗
The vaccine candidate was highly efficacious, demonstrating overall vaccine efficacy of 82.6% (96.95% CI, 57.9–94.1) against RSV lower respiratory tract disease (RSV-LRTD), meeting the trial’s primary endpoint. |
| 2022-06-23 | Targovax Oy | Regulatory Targovax: FDA gir tillatelse til å starte kliniske studier med ny og forbedret TG01 kreftvaksine i USA circio.com ↗
Targovax ASA (OSE: TRVX) melder i dag at en «legemiddel under utvikling» (IND) søknad for TG01 i kombinasjon med QS-21 STIMULON har blitt godkjent av det amerikanske FDA. |
| 2022-06-23 | Targovax Oy | Regulatory Targovax: FDA gir tillatelse til å starte kliniske studier med ny og forbedret TG01 kreftvaksine i USA circio.com ↗
Targovax ASA (OSE: TRVX) melder i dag at en «legemiddel under utvikling» (IND) søknad for TG01 i kombinasjon med QS-21 STIMULON har blitt godkjent av det amerikanske FDA. |
| 2022-06-23 | Targovax Oy | Regulatory Targovax announces that the FDA has granted authorization to initiate clinical trials with the enhanced TG01 RAS vaccine in the USA circio.com ↗
The US Food and Drug Administration (FDA) has approved an Investigational New Drug (IND) Application for the combination of TG01 and QS-21 STIMULON™ |
| 2022-06-10 | Agenus Inc. | Results GSK’s RSV vaccine candidate for older adults, containing Agenus’ QS-21 STIMULON™ as part of GSK’s AS01 adjuvant, reports positive pivotal data supporting initiation of global regulatory submissions agenusbio.com ↗
Agenus (NASDAQ: AGEN), an immuno-oncology company with an extensive pipeline of therapies and adjuvants designed to activate the immune response to cancer and infections, today shared that partner GSK announced positive headline results from a pre-specified efficacy interim analysis of the AReSVi 006 phase III trial evaluating their investigational RSV vaccine in adults aged 60 years and above. |
| 2017-10-25 | Agenus Inc. | Regulatory Shingrix with QS-21 Stimulon® Receives Positive Recommendation from CDC's Advisory Committee on Immunization Practices as Preferred Vaccine for Prevention of Shingles agenusbio.com ↗
Herpes Zoster subunit vaccine (Shingrix) is preferred over Zoster Vaccine Live (Zostavax) for the prevention of herpes zoster and related complications. |
| 2017-10-20 | Agenus Inc. | Regulatory FDA Approves GSK's Shingles Vaccine with Agenus' QS-21 Stimulon® Adjuvant agenusbio.com ↗
Agenus Inc. (NASDAQ: AGEN), an immuno-oncology company with a pipeline of immune checkpoint antibodies and cancer vaccines, announced today that the US Food and Drug Administration (FDA) granted marketing authorization to GlaxoSmithKline's (GSK) herpes zoster vaccine, SHINGRIX, containing Agenus' proprietary immune adjuvant QS-21 Stimulon®. |
| 2017-10-13 | Agenus Inc. | Regulatory GSK's Shingrix Containing Agenus' QS-21 Stimulon® Adjuvant Receives Marketing Authorization from Health Canada agenusbio.com ↗
Agenus Inc. (NASDAQ: AGEN), an immuno-oncology company with a pipeline of immune checkpoint antibodies and cancer vaccines, announced today that Health Canada granted marketing authorization to GlaxoSmithKline's (GSK) shingles vaccine, Shingrix, that contains Agenus' proprietary immune adjuvant QS-21 Stimulon ® adjuvant. |
| 2017-09-13 | Agenus Inc. | Regulatory GSK's Shingrix containing Agenus' QS-21 Stimulon® adjuvant receives Unanimous FDA Advisory Committee recommendation for approval agenusbio.com ↗
Agenus Inc. (NASDAQ: AGEN), an immuno-oncology company with a pipeline of immune checkpoint antibodies and cancer vaccines, announced today that GlaxoSmithKline's (GSK) shingles vaccine candidate, Shingrix, containing Agenus' proprietary immune adjuvant, QS-21 Stimulon®, was unanimously recommended for approval by the U.S. Food and Drug Administration's (FDA) Vaccines and Related Biological Products Advisory Committee. |
| 2017-06-21 | Agenus Inc. | Results Positive Phase 3 for GSK's shingles vaccine Shingrix with Agenus' QS-21 Stimulon® immune adjuvant agenusbio.com ↗
Shingrix, containing Agenus' proprietary immune adjuvant, QS-21 Stimulon®, triggered a strong immune response in elderly patients previously treated with the current vaccine, Zostavax®, for the prevention of shingles. |
| 2015-10-27 | Agenus Inc. | Results GSK’s candidate Shingles Vaccine Containing Agenus’ QS-21 Stimulon® Demonstrates 90% Efficacy against Shingles and 89% Efficacy against Post-Herpetic Neuralgia in Adults aged 70 Years and Older agenusbio.com ↗
Agenus Inc. (NASDAQ:AGEN), an immunology company discovering and developing innovative treatments for cancer and other diseases, announced today that GlaxoSmithKline’s plc (LSE/NYSE:GSK) second pivotal Phase III efficacy study of its shingles vaccine candidate containing Agenus’ QS-21 Stimulon® adjuvant demonstrated 90% overall efficacy against shingles compared to placebo. |
| 2015-07-24 | Agenus Inc. | Regulatory GSK’s Malaria Vaccine Containing Agenus’ QS-21 Stimulon® Receives Positive Opinion from European Regulators for Prevention of Malaria in Young Children in Sub-Saharan Africa agenusbio.com ↗
The vaccine candidate, named Mosquirix™ (RTS,S) is the first QS-21 Stimulon containing product to receive a positive regulatory decision. |
| 2015-04-28 | Agenus Inc. | Results NEJM Publishes Study Showing GSK’s Shingles Vaccine Containing Agenus’ QS-21 Stimulon® Adjuvant Provides over 97% Protection in People Over the Age of 50 agenusbio.com ↗
The data show that GSK’s HZ/su reduced the risk of shingles (herpes zoster) by 97.2% in adults aged 50 and older, compared to placebo. |
| 2015-04-24 | Agenus Inc. | Results GSK’s Malaria Vaccine Phase 3 Study Containing Agenus’ QS-21 Published in The Lancet agenusbio.com ↗
The study demonstrated a statistically significant reduction against malaria in children who received RTS,S followed by a booster shot of the vaccine at 18 months. |
| 2014-12-18 | Agenus Inc. | Results Positive Outcome of Phase 3 Study of GSK Shingles Vaccine Containing Agenus Adjuvant agenusbio.com ↗
Analysis of the primary endpoint showed that HZ/su reduced the risk of shingles by 97.2 per cent in adults aged 50 years and older compared to placebo. |
| 2014-04-02 | GlaxoSmithKline | Results Update on phase III clinical trial of investigational MAGE-A3 antigen-specific cancer immunotherapeutic in non-small cell lung cancer gsk.com ↗
However, the pre-planned independent third-party analysis of a proportion of the datav (to identify a gene signature classifier) has concluded that assessment of the third co-primary endpoint is not feasible due to an insufficient treatment effect. |
| 2014-04-02 | Agenus Inc. | Results Update On GSK’S MAGE-A3 Cancer Immunotherapeutic Phase 3 Study in Non-Small Cell Lung Cancer agenusbio.com ↗
GSK announced that it will not be possible to identify a sub-population of gene-signature positive NSCLC patients that may benefit from the treatment. |
| 2014-03-20 | Agenus Inc. | Results GSK’s MAGE-A3 Cancer Immunotherapeutic Phase 3 Study in Non-small Cell Lung Cancer Misses First Co-primary Endpoints agenusbio.com ↗ |
| 2013-10-07 | Agenus Inc. | Results GSK’s Vaccine Candidate Containing Agenus’ QS-21 Stimulon® Reduces Malaria Infection in Phase 3 Trials of Over 15,000 Children agenusbio.com ↗
These findings indicate that RTS,S has the potential to help prevent millions of malaria cases. |
| 2013-09-05 | Agenus Inc. | Results GSK’S MAGE-A3 Cancer Immunotherapeutic Phase 3 Study in Melanoma Misses First Co-Primary Endpoint agenusbio.com ↗ |
All press releases naming this drug 27 releases
Evidence & citations 9 cited values
Every value below carries the sentence it was read from. 37 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | QS-21 | “The vaccines were administered s.c. in either of two adjuvants, Montanide ISA-51 or QS-21, to 22 patients with high-risk resected melanoma (stage IIB-IV).” PMID 11595689 ↗ Oct 200137“QS-21 is a naturally occurring saponin molecule purified from the South American tree Quillaja saponaria Molina.” NCT05841550 ↗ “Vanutide Cridificar (ACC-001) 3µg + QS-21 (50µg), IM on Day 1, Month 6, Month 12 and Month 18” NCT00955409 ↗ “12 mcg Influenza A (H7N9) with 4 mcg QS21 Microarray Patch Delivery System (VXS-1219A)” NCT06417853 ↗ “106-amino acid-long MUC1 peptide conjugated with KLH plus immune adjuvant QS-21” PMID 11807794 ↗ Feb 2002 “ACC-001 3mcg + QS-21 50 mcg Intra-muscular (IM) q 6 mo” NCT00960531 ↗ “with QS-21 Stimulon® adjuvant” NCT02992977 ↗ “QS-21, a saponin adjuvant” NCT06741072 ↗ “adjuvant QS-21” NCT00006041 ↗ |
| Known as | MUC1-KLH vaccine/QS21 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT00005632 ↗ |
| Known as | QUILLAJA SAPONIN (QS-21) | “QUILLAJA SAPONIN (QS-21)” NCT06741072 ↗ |
| Known as | Stimulation-QS-21 | “QS-21 (Stimulation-QS-21) Drug” NCT00001572 ↗ |
| Known as | Stimulon | “with QS-21 Stimulon® adjuvant” NCT02992977 ↗ |
| Action | Deplete | “Vaccines may make the body build an immune response to kill tumor cells.” NCT00005632 ↗ |
| Modality | Vaccine | “Patients sequentially will receive glycosylated MUC-1-KLH vaccines at 3ug per vaccination.” NCT00005632 ↗ |
| Route | Subcutaneous | “The vaccine is administered with subcutaneous QS-21 as an immunological adjuvant.” NCT00001572 ↗ |
| Target | MUC1 | “response against MUC-1” NCT00005632 ↗ |