Drugs / agatolimod
agatolimod
also known as
CpG 7909 · PF-3512676 · CpG 10104 · agatolimod sodium · PF-03512676 · Agatolimod tricosasodium salt · CpG ODN 7909 · CpG7909 ODN · +2 more
Oligonucleotide (other) targets TLR9 via activation
Trials 44
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 119 trials | ||||||
| Phase 1 | NCT03373214 | Feb 2018 → Feb 2019 | hookworm infectious disease | Baylor College of Medicine | Completed | No outcome recorded |
| Phase 1 | NCT02143518 | Oct 2014 → Jun 2016 | hookworm infectious disease | Baylor College of Medicine | Completed | No outcome recorded |
| Phase 1 | NCT01588015 | Oct 2012 → Feb 2024 | B-cell adult acute lymphocytic leukemia, Burkitt lymphoma, MALT lymphoma, T-cell adult acute lymphocytic leukemia +34 | City of Hope Medical Center | Completed | No outcome recorded |
| Phase 1 | NCT01164514 | Nov 2011 → Feb 2013 | bacterial infectious disease with sepsis | National Institute of Allergy and Infectious Diseases (NIAID) | Terminated | No outcome recorded |
| Phase 1 | NCT01351948 | Jun 2011 → Mar 2013 | malaria | University of Oxford | Completed | No outcome recorded |
| Phase 1 | NCT01263691 | Dec 2010 → May 2012 | anthrax infection | Emergent BioSolutions | Completed | No outcome recorded |
| Phase 1 | NCT00819806 | Jan 2009 → May 2012 | melanoma tumor antigen Gp90 | Hassane M. Zarour, MD | Completed | No outcome recorded |
| Phase 1 | NCT00471471 | Oct 2008 → Dec 2011 | conjunctival cancer, cutaneous melanoma, ocular melanoma | Ahmad Tarhini | Completed | No outcome recorded |
| Phase 1 | NCT00559975 | Oct 2007 → May 2008 | influenza | Novartis | Completed | No outcome recorded |
| Phase 1 | NCT00427167 | Jan 2007 → Nov 2008 | malaria | National Institute of Allergy and Infectious Diseases (NIAID) | Completed | No outcome recorded |
| Phase 1 | NCT00414336 | Dec 2006 | malaria | National Institute of Allergy and Infectious Diseases (NIAID) | Completed | No outcome recorded |
| Phase 1 | NCT00722839 | Dec 2006 → Apr 2012 | — | City of Hope Medical Center | Completed | No outcome recorded |
| Phase 1 | NCT00320658 | Mar 2006 → Jul 2007 | malaria | National Institute of Allergy and Infectious Diseases (NIAID) | Completed | No outcome recorded |
| Phase 1 | NCT00344539 | May 2005 → Jan 2007 | Plasmodium falciparum malaria | National Institute of Allergy and Infectious Diseases (NIAID) | Completed | No outcome recorded |
| Phase 1 | NCT00340574 | Mar 2005 → Jul 2008 | — | National Institute of Allergy and Infectious Diseases (NIAID) | Completed | No outcome recorded |
| Phase 1 | NCT00292045 | Oct 2004 → Jan 2006 | prostate cancer | Ludwig Institute for Cancer Research | Completed | No outcome recorded |
| Phase 1 | NCT00233506 | Jul 2004 → Jun 2011 | chronic lymphocytic leukemia/small lymphocytic lymphoma | University of Iowa | Completed | No outcome recorded |
| Phase 1 | NCT00112242 | Feb 2004 → Mar 2013 | melanoma | Centre Hospitalier Universitaire Vaudois | Completed | No outcome recorded |
| Phase 1 | NCT00040950 | Mar 2002 → Oct 2007 | lymphoma | Jonsson Comprehensive Cancer Center | Completed | No outcome recorded |
| Phase 1/211 trials · 1 met primary | ||||||
| Phase 1/2 | NCT00562939 | Jan 2008 → Jan 2009 | HIV infectious disease | University of Aarhus | Completed | Met primary |
| Phase 1/2 | NCT00669292 | Nov 2006 → Nov 2009 | esophageal cancer | Wakayama Medical University | Unknown | No outcome recorded |
| Phase 1/2 | NCT00226993 | Mar 2005 → Dec 2006 | mycosis fungoides | Stanford University | Withdrawn | No outcome recorded |
| Phase 1/2 | NCT00145145 | Jan → Apr 2005 | melanoma | Ludwig Institute for Cancer Research | Terminated | No outcome recorded Stop: Enrollment |
| Phase 1/2 | NCT00145158 | Jan 2005 → Nov 2007 | melanoma | Ludwig Institute for Cancer Research | Terminated | No outcome recorded |
| Phase 1/2 | NCT00100633 | Dec 2004 → Feb 2007 | HIV infectious disease, hepatitis B virus infection | National Institute of Allergy and Infectious Diseases (NIAID) | Completed | No outcome recorded |
| Phase 1/2 | NCT00438880 | Oct 2004 → Oct 2010 | MALT lymphoma, Waldenstrom macroglobulinemia, chronic lymphocytic leukemia/small lymphocytic lymphoma, diffuse large B-cell lymphoma +3 | Mayo Clinic | Completed | No outcome recorded |
| Phase 1/2 | NCT00185965 | Jul 2004 → Mar 2010 | mycosis fungoides | Ronald Levy | Completed | No outcome recorded |
| Phase 1/2 | NCT00043420 | Jan 2003 → Mar 2007 | primary cutaneous T-cell lymphoma | Pfizer | Completed | No outcome recorded |
| Phase 1/2 | NCT00043407 | Mar 2002 → Sep 2004 | renal cell carcinoma | Pfizer | Completed | No outcome recorded |
| Phase 1/2 | NCT00031278 | Oct 2001 → Jun 2003 | breast carcinoma | Pfizer | Completed | No outcome recorded |
| Phase 212 trials · 2 missed | ||||||
| Phase 2 | NCT03172975 | Mar 2018 → Dec 2024 | hookworm infectious disease | Baylor College of Medicine | Completed | Missed primary |
| Phase 2 | NCT00490529 | Aug 2009 → Dec 2017 | mantle cell lymphoma | Ronald Levy | Completed | No outcome recorded |
| Phase 2 | NCT00824733 | Feb 2009 → Feb 2013 | breast cancer | Bhuvaneswari Ramaswamy | Terminated | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT00880581 | Jan 2009 → Sep 2011 | indolent B-cell non-Hodgkin lymphoma | Ronald Levy | Completed | No outcome recorded |
| Phase 2 | NCT00471159 | Aug 2007 → ? | breast cancer | Pfizer | Withdrawn | No outcome recorded |
| Phase 2 | NCT00321308 | Sep 2006 → Jan 2008 | non-small cell lung carcinoma | Pfizer | Terminated | No outcome recorded |
| Phase 2 | NCT00321815 | Aug 2006 → Jun 2010 | non-small cell lung carcinoma | Pfizer | Completed | Missed primary |
| Phase 2 | NCT00313768 | Dec 2005 → May 2008 | non-small cell lung carcinoma | Pfizer | Terminated | No outcome recorded |
| Phase 2 | NCT00070642 | Dec 2003 → Dec 2005 | melanoma | Pfizer | Completed | No outcome recorded |
| Phase 2 | NCT00070629 | May 2003 → Jul 2007 | non-small cell lung carcinoma | Pfizer | Completed | No outcome recorded |
| Phase 2 | NCT00043394 | Sep 2002 → Oct 2003 | breast carcinoma | Pfizer | Completed | No outcome recorded |
| Phase 2 | NCT00043368 | Sep 2002 → Jun 2007 | T-cell non-Hodgkin lymphoma, breast neoplasm, melanoma, non-small cell lung carcinoma +1 | Pfizer | Completed | No outcome recorded |
| Phase 32 trials | ||||||
| Phase 3 | NCT00254904 | Nov 2005 → Jun 2008 | non-small cell lung carcinoma | Pfizer | Terminated | No outcome recorded |
| Phase 3 | NCT00254891 | Nov 2005 → Jul 2008 | non-small cell lung carcinoma | Pfizer | Terminated | No outcome recorded |
| Comparator or background therapy9 trials | ||||||
| Phase 1 | NCT07221162 Background | Dec 2025 → Nov 2026 expected | COVID-19 | National Institute of Allergy and Infectious Diseases (NIAID) | Active not recruiting | No outcome recorded |
| Phase 1 | NCT00889616 Background | Apr 2009 → Jul 2012 | malaria | National Institute of Allergy and Infectious Diseases (NIAID) | Completed | No outcome recorded |
| Phase 1 | NCT00740090 Background | Aug 2008 → Jun 2009 | malaria | National Institute of Allergy and Infectious Diseases (NIAID) | Completed | No outcome recorded |
| Phase 1 | NCT00299728 Background | Mar → Oct 2006 | neoplasm | Ludwig Institute for Cancer Research | Completed | No outcome recorded |
| Phase 1 | NCT00199836 Background | Sep 2003 → Sep 2005 | cancer | Ludwig Institute for Cancer Research | Completed | No outcome recorded |
| Phase 1 | NCT00112229 Background | Apr 2003 → Aug 2011 | melanoma | Centre Hospitalier Universitaire Vaudois | Completed | No outcome recorded |
| Phase 1/2 | NCT00984763 Background | Jan → Sep 2010 | malaria | University of Oxford | Completed | Missed primary |
| Phase 2 | NCT01266603 Background | Feb 2011 → Nov 2018 | melanoma | M.D. Anderson Cancer Center | Completed | No outcome recorded |
| Phase 2 | NCT00085189 Background | May 2004 → Sep 2007 | iris melanoma, medium/large size posterior uveal melanoma, mucosal melanoma, ocular melanoma with extraocular extension +1 | University of Southern California | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 1
| Date | Issuer | Release |
|---|---|---|
| 2011-08-26 | Emergent BioSolutions | Results Results of Emergent BioSolutions Phase 1a Study on Adjuvanted BioThrax Anthrax Vaccine Published in the Journal Vaccine emergentbiosolutions.com ↗
Data from the trial show that BioThrax plus CPG 7909 generated peak antibody responses that were 6-fold higher than those generated by BioThrax alone (232 g/ml with BioThrax alone; 1465 g/ml with BioThrax plus CPG 7909). |
All press releases naming this drug 2 releases
| Date | Issuer | Release |
|---|---|---|
| 2011-08-26 | Emergent BioSolutions | Results of Emergent BioSolutions Phase 1a Study on Adjuvanted BioThrax Anthrax Vaccine Published in the Journal Vaccine emergentbiosolutions.com ↗ |
| 2007-03-15 | Emergent BioSolutions | Emergent BioSolutions Gains Rights To VaxImmune(TM) From Coley Pharmaceutical Group to Expand Its Anthrax Franchise emergentbiosolutions.com ↗ |
Evidence & citations 15 cited values
Every value below carries the sentence it was read from. 62 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | agatolimod | ClinicalTrials.gov intervention name — accepted as the source's own label NCT00040950 ↗ |
| Known as | agatolimod sodium | ClinicalTrials.gov intervention name — accepted as the source's own label NCT00722839 ↗ |
| Known as | Agatolimod tricosasodium salt | ChEMBL registry synonym — accepted as the source's own label CHEMBL2103792 ↗ |
| Known as | CpG 10104 | “Na-GST-1/Al in combination with CpG 10104 (Na-GST-1/Al-CpG), Na-GST-1/Al in combination with AP 10-701 (Na-GST-1/Al-AP), or placebo.” PMID 41861834 ↗ Mar 2026 |
| Known as | CpG 7909 | “Phase 2 trial of erlotinib with or without PF-3512676 (CPG 7909, a Toll-like receptor 9 agonist) in patients with advanced recurrent EGFR-positive non-small cell lung cancer.” PMID 23792641 ↗ May 201335“recMAGE-A3 300 μg plus 420 μg of CpG7909 (a part of the Adjuvant System AS15) by intermuscular injection within 24 hours from first dose of HDIL-2.” NCT01266603 ↗ “The CPG 7909 adjuvant group had significantly higher relative cytokine responses than the placebo group” PMID 22854665 ↗ Aug 2012 “CPG 7909 is a synthetic short DNA sequence that has been shown to be an effective vaccine adjuvant” NCT01263691 ↗ “different doses of CpG7909 in patients with advanced or recurrent esophageal cancer” NCT00669292 ↗ “NY-ESO-1 recombinant protein mixed with CpG 7909 and Montanide ISA-51 VG” NCT00299728 ↗ “first, CpG 7909 oligodeoxynucleotides, and second, Montanide ISA-51.” NCT00112229 ↗ “AMA1-C1/Alhydrogel + CpG 7909” NCT00340574 ↗ “2.5 mg CpG-7909/PF-3512676” NCT00112242 ↗ |
| Known as | CpG ODN 7909 | “Montanide ISA-51, and CpG ODN 7909, a potent stimulator of B cells and T helper type 1 (Th1)-type immunity” PMID 17517626 ↗ May 2007 |
| Known as | CpG7909 ODN | “a boosting agent called CpG7909 ODN may be an ideal adjuvant for vaccines given to HIV infected people” NCT00100633 ↗ |
| Known as | PF-03512676 | “PRIMARY OBJECTIVES: I. To discover whether two administrations of 2.5 mg tetanus (Tet)-CMV peptide co-injected with 1 mg of PF-03512676 (tetanus-CMV fusion peptide vaccine)” NCT01588015 ↗2“It is formulated with the adjuvant PF03512676, a Toll-like receptor 9 agonist, which augments cellular immunity.” PMID 26853648 ↗ Dec 2015 |
| Known as | PF-3512676 | “PF-3512676, Montanide ISA 720 VG and MHC class I peptides from NY-ESO-1 (NY-ESO-1 157-165V, NY-ESO-1 53-62 (MPS-190) and NY-ESO-1 94-102) in three subcutaneous injections...” NCT00819806 ↗13“combined with the TLR9 agonist PF-3512676 and local granulocyte macrophage-colony stimulating factor in oil emulsion” PMID 22495394 ↗ May 2012 “2.5 mg CpG-7909/PF-3512676” NCT00112242 ↗ |
| Known as | Pf-3512676 free acid | ChEMBL registry synonym — accepted as the source's own label CHEMBL2103792 ↗ |
| Known as | VaxImmune | “CPG 7909 Oligodeoxynucleotide (VaxImmune®)” NCT00344539 ↗ |
| Action | Activate | “PF-3512676 (formerly CPG 7909) is a Toll-like receptor 9 agonist” PMID 20888065 ↗ Dec 2010 |
| Modality | Oligonucleotide (other) | “CpG7909 oligodeoxynucleotides (ODN)” NCT00100633 ↗ |
| Route | Intravenous | “PF-3512676 IV at doses:” NCT00043368 ↗ |
| Target | TLR9 | “CpG ODNs trigger Toll-like receptor 9” PMID 15696196 ↗ Mar 2005 |