Rintatolimod
drug drugOn this page
Also known as AmpligenAtvogenPoly i : poly c12uPoly i: poly c12u
Summary
Rintatolimod (CHEMBL2107862) is a phase-3 clinical-stage unknown; indicated across 15 conditions including myalgic encephalomeyelitis/chronic fatigue syndrome and encephalomyelitis.
At a glance
- Status: Max clinical phase 3 (not approved)
- Modality: Unknown
- Indications: 15 conditions
- Clinical trials: 20
Identifiers
Drug identity and classification
| Field | Value |
|---|---|
| ChEMBL ID | CHEMBL2107862 |
| Name | Rintatolimod |
| Type | Unknown |
| Max phase | 3 |
Also known as: Ampligen, Atvogen, Poly i : poly c12u, Poly i: poly c12u, Rintatolimod, RINTATOLIMOD
Targets
Targets
No target linkage available.
Bioactivity
No ChEMBL bioactivity rows at pChembl ≥ 5 (expected for biologics / antibodies).
Target pathways
No target-pathway data for this drug (no mapped target genes).
Indications & clinical
Indications
15 diseases in clinical trials (phase 1–3, investigational — not approved indications). Highest ChEMBL trial phase per disease; a non-cancer approved use is occasionally logged at phase 3 here.
| Disease (in trials) | Phase | MONDO | EFO |
|---|---|---|---|
| myalgic encephalomeyelitis/chronic fatigue syndrome | 3 | MONDO:0005404 | EFO:0004540 |
| encephalomyelitis | 3 | MONDO:0005156 | EFO:0001423 |
| prostate adenocarcinoma | 2 | MONDO:0005082 | EFO:0000673 |
| melanoma | 2 | MONDO:0005105 | EFO:0000756 |
| exocrine pancreatic carcinoma | 2 | MONDO:0005192 | EFO:0002618 |
| long COVID-19 | 2 | MONDO:0100233 | MONDO:0100233 |
| male breast carcinoma | 1 | MONDO:0005628 | EFO:0006861 |
| HIV infectious disease | 1 | MONDO:0005109 | EFO:0000764 |
| fallopian tube neoplasm | 1 | MONDO:0021092 | MONDO:0002158 |
| breast carcinoma in situ | 1 | MONDO:0004658 | MONDO:0004658 |
| breast neoplasm | 1 | MONDO:0021100 | MONDO:0007254 |
| ovarian cancer | 1 | MONDO:0008170 | MONDO:0008170 |
| severe acute respiratory syndrome | 1 | MONDO:0005091 | MONDO:0100096 |
| hematopoietic and lymphoid system neoplasm | 1 | MONDO:0002334 | MONDO:0044881 |
| triple-negative breast carcinoma | 1 | MONDO:0005494 | EFO:0005537 |
Clinical trials
Total trials: 20.
Phase distribution
| Phase | Trials |
|---|---|
| PHASE1/PHASE2 | 7 |
| PHASE2 | 6 |
| PHASE1 | 3 |
| Not specified | 2 |
| PHASE3 | 1 |
| EARLY_PHASE1 | 1 |
Top trials by phase / activity
| NCT | Phase | Status | Title |
|---|---|---|---|
| NCT00215800 | PHASE3 | COMPLETED | The Study of the Safety and Efficacy of Ampligen in Chronic Fatigue Syndrome |
| NCT03734692 | PHASE1/PHASE2 | ACTIVE_NOT_RECRUITING | Systemic Immune Checkpoint Blockade and Intraperitoneal Chemo-Immunotherapy in Recurrent Ovarian Cancer |
| NCT03899987 | PHASE2 | ACTIVE_NOT_RECRUITING | Aspirin and Rintatolimod With or Without Interferon-alpha 2b in Treating Patients With Prostate Cancer Before Surgery |
| NCT05927142 | PHASE1/PHASE2 | RECRUITING | Combining Anti-PD-L1 Immune Checkpoint Inhibitor Durvalumab With TLR-3 Agonist Rintatolimod in Patients With Metastatic Pancreatic Ductal Adenocarcinoma for Therapy Efficacy |
| NCT01312389 | PHASE1/PHASE2 | TERMINATED | A Clinical Trial of Autologous Oxidized Tumor Cell Lysate Vaccine For Recurrent Ovarian, Fallopian Tube or Primary Peritoneal Cancer |
| NCT01355393 | PHASE1/PHASE2 | COMPLETED | Vaccine Therapy in Combination With Rintatolimod and/or Sargramostim in Treating Patients With Stage II-IV HER2-Positive Breast Cancer |
| NCT02151448 | PHASE1/PHASE2 | COMPLETED | αDC1 Vaccine + Chemokine Modulatory Regimen (CKM) as Adjuvant Treatment of Peritoneal Surface Malignancies |
| NCT03403634 | PHASE2 | COMPLETED | Celecoxib, Recombinant Interferon Alfa-2b, and Rintatolimod in Treating Patients With Colorectal Cancer Metastatic to the Liver |
| NCT04093323 | PHASE2 | TERMINATED | Polarized Dendritic Cell (aDC1) Based Treatment, Interferon Alpha-2, Rintatolimod, and Celecoxib for the Treatment of HLA-A2+ Refractory Melanoma |
| NCT04119830 | PHASE2 | WITHDRAWN | Rintatolimod and Pembrolizumab for the Treatment of Refractory Metastatic or Unresectable Colorectal Cancer |
| NCT04379518 | PHASE1/PHASE2 | TERMINATED | Rintatolimod and IFN Alpha-2b for the Treatment of COVID-19 in Cancer Patients |
| NCT05494697 | PHASE2 | SUSPENDED | Ampligen Combined With SOC Versus SOC Alone Following First-Line Therapy in Subjects With LAPC |
| NCT05592418 | PHASE2 | COMPLETED | Study to Evaluate the Efficacy and Safety of Ampligen in Patients With Post-COVID Conditions |
| NCT05756166 | PHASE1/PHASE2 | TERMINATED | Rintatolimod, Celecoxib and Interferon Alpha 2b With Pembrolizumab For the Treatment of Patients With Metastatic or Unresectable Triple Negative Breast Cancer |
| NCT00000713 | PHASE1 | COMPLETED | A Phase I Clinical Trial To Evaluate the Toxicity, Antiviral and Immunomodulatory Effects of a Range of Doses of Ampligen in HIV-Infected Subjects |
| NCT00000735 | PHASE1 | COMPLETED | A Clinical Trial To Evaluate the Toxicity and Antiviral Effects of a Range of Doses of Ampligen in p24 Antigen Positive HIV-Infected Patients With AIDS or ARC |
| NCT04081389 | PHASE1 | COMPLETED | Chemokine Modulation Therapy and Standard Chemotherapy Before Surgery for the Treatment of Early Stage Triple Negative Breast Cancer |
| NCT03599453 | EARLY_PHASE1 | COMPLETED | Chemokine Modulation Therapy and Pembrolizumab in Treating Participants With Metastatic Triple-Negative Breast Cancer |
| NCT00001000 | Not specified | COMPLETED | A Study of Atvogen in Healthy Volunteers and HIV-Infected Patients Who Have No Symptoms of Infection |
| NCT00002269 | Not specified | COMPLETED | A Multicenter, Double-Blind, Controlled Study to Evaluate Ampligen |
Clinical evidence (CIViC)
No CIViC predictive evidence (expected for non-precision-medicine drugs).
Pharmacology
Pharmacogenomics
No PharmGKB pharmacogenomic data curated for this drug.
Related molecules
Related molecules
No competitor molecules sharing a primary target (ChEMBL phase ≥2 or PubChem drug-class).