Drugs / agatolimod
last change Mar 2026 re-read 2 minutes ago

agatolimod

Oligonucleotide (other) targets TLR9 via activation

Developed for
non-small cell lung carcinoma · melanoma · chronic lymphocytic leukemia/small lymphocytic lymphoma · mantle cell lymphoma · breast cancer · breast carcinoma · diffuse large B-cell lymphoma · MALT lymphoma
+18 more · mycosis fungoides · nodal marginal zone B-cell lymphoma · renal cell carcinoma · Waldenstrom macroglobulinemia · breast neoplasm · conjunctival cancer · cutaneous melanoma · cytomegalovirus infection · esophageal cancer · hepatitis B virus infection · indolent B-cell non-Hodgkin lymphoma · lymphoma · melanoma tumor antigen Gp90 · ocular melanoma · Plasmodium falciparum malaria · primary cutaneous T-cell lymphoma · splenic marginal zone lymphoma · T-cell non-Hodgkin lymphoma
Investigated by
Pfizer · National Institute of Allergy and Infectious Diseases (NIAID) · National Cancer Institute (NCI) · Ludwig Institute for Cancer Research · Baylor College of Medicine · George Washington University
+27 more · Ronald Levy · City of Hope Medical Center · Mayo Clinic · National Institutes of Health (NIH) · Aarhus University Hospital · Academic Medical Center - University of Amsterdam · Ahmad Tarhini · American Society of Clinical Oncology · Amsterdam Institute for Global Health and Development · Bhuvaneswari Ramaswamy · Centre Hospitalier Universitaire Vaudois · Centre de Recherche Médicale de Lambaréné · Department of Health and Human Services · Emergent BioSolutions · Hassane M. Zarour, MD · Human Genome Center, Institute of Medical Science, University of Tokyo · Johns Hopkins Bloomberg School of Public Health · Jonsson Comprehensive Cancer Center · Leiden University Medical Center · Lymphoma Research Foundation · Novartis · Novartis Vaccines · Stanford University · University of Aarhus · University of Iowa · University of Oxford · Wakayama Medical University

Trials 44 · a red edge is where a trial was stopped

PhaseRegistry idDatesIndicationSponsorStatusOutcome
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 1/211 trials
Phase 1/2 NCT00562939 Jan 2008 → Jan 2009 HIV infectious disease University of Aarhus Completed No outcome recorded
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
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 212 trials
Phase 2 NCT03172975 Mar 2018 → Dec 2024 hookworm infectious disease Baylor College of Medicine Completed No outcome recorded
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
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 No outcome recorded
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 32 trials
Phase 3 NCT00254891 Nov 2005 → Jul 2008 non-small cell lung carcinoma Pfizer Terminated No outcome recorded
Phase 3 NCT00254904 Nov 2005 → Jun 2008 non-small cell lung carcinoma Pfizer Terminated No outcome recorded
Also used as a comparator or background therapy in 9 trials
PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 16 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 1/21 trial
Phase 1/2 NCT00984763 Background Jan → Sep 2010 malaria University of Oxford Completed No outcome recorded
Phase 22 trials
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

Evidence & citations 15 cited values

Every value below carries the sentence it was read from. 62 sources stand behind the page.

FieldValueCited 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 NCT00438880
2

NCT00722839

NCT00085189

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
3

NCT03373214

NCT03172975

NCT02143518

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 2013
35

“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

“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

CpG 7909 (escalating doses: 0, 0.02, 0.1mg/kg)” NCT00669292

“AMA1-C1/Alhydrogel + CpG 7909NCT00340574

“2.5 mg CpG-7909/PF-3512676” NCT00112242

NCT00414336

NCT00344539

NCT00559975

NCT00233506

NCT00100633

NCT00070642

NCT00070629

NCT00043407

NCT00185965

NCT00669292

NCT01351948

NCT00340574

NCT00984763

NCT00292045

NCT00320658

NCT00740090

NCT00562939

NCT00427167

NCT00145145

NCT01164514

NCT07221162

NCT00226993

NCT00199836

NCT00043394

NCT00031278

NCT00145158

NCT00889616

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

NCT00824733

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-3512676NCT00112242

NCT00321815

NCT00471471

NCT00254904

NCT00043420

NCT00254891

NCT00313768

NCT00471159

NCT00880581

NCT00043368

NCT00321308

NCT00490529

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