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  • News bot Jan. 29, 2026, 6:46 p.m.

    📋 Cara Therapeutics (CARA) - Clinical Trial Update

    Filing Date: 2026-01-16

    Accepted: 2026-01-16 06:04:33

    Event Type: Clinical Trial Update

    Event Details:

    Cara Therapeutics (CARA) Announces Clinical Trial Update Cara Therapeutics (CARA) provided an update on its clinical development programs. Clinical Development Highlights:
    • Drug Program: approvals, contained
    • Clinical Stage: clinical trial
      • Targeting STAT3: Central Mediator of Fibrosis-Driven Diseases Deep expertise in STAT3 biology Potential to serve as a disease-modifying therapy TTI-109: designed to enhance delivery of STAT3 inhibitor & improve tolerability Multiple near-term data catalysts expected • Unlocking highly-validated target within fibrosis-driven diseases • Demonstrated target engagement and disease modification across animal models of proliferative disease • Demonstrated enhanced biological activity in fibrotic cancers in P1 • Observed reductions in fibrosis and inflammation marker (IL-6) in IPF1 P2 • Evaluating mono- and combination therapy in fibrosis-driven HCC2 P2 • TTI-109 P1 healthy volunteer data in 1H:2026
      • expected in 1H:2026
      • expected in this patient populationTreatment emergent adverse event: any adverse event that emerges after treatment with TTI-101 or placebo. Safety analysis performed on all patients treated with at least one dose of TTI-101. 2No instances of drug-induced liver injury reported across visits or treatment groups. All increases in investigations (labs) were transient. 13 Treatment-Emergent Adverse Events Resulting in Discontinuations by Concomitant Nintedanib Use Dose Placebo (n=29) TTI-101 400mg/day (n=30) TTI-101 800mg/day (n=29) Reason for discontinuation by concomitant nintedanib use Nintedanib (n=17) Placebo (n=12) TTI-101 + Nintedanib (n=18) TTI-101 alone (n=12) TTI-101 + Nintedanib (n=16) TTI-101 alone (n=13) Gastrointestinal disorders 2 4 7 4 Investigations (Labs)2 4 4 2 Respiratory, thoracic and mediastinal disorders 1 3 2 1 2 Majority of discontinuations were observed with concomitant nintedanibAdverse events selected to align with INPULSIS categories; safety analysis performed on all patients treated with at least one dose of TTI-101. Certain data on this slide are based on cross-study comparisons and are not based on any head-to-head clinical trials. Cross-study comparisons are inherently limited and may suggest misleading similarities and differences. The values shown in the cross-study comparisons are directional and may not be directly comparable. 1Richeldi et al. NEJM, 2014

    🔬 Clinical Development Pipeline (Cara Therapeutics):

    Product Type Development Stage Therapeutic Area Source
    nula-cel Drug Product GENETIC Phase PHASE1 Sickle Cell Disease ClinicalTrials.gov
    CHR-2797 (tosedostat): Aminopeptidase inhibitor DRUG Phase PHASE1 Acute Myeloid Leukemia ClinicalTrials.gov
    MA09-hRPE Cellular Therapy BIOLOGICAL Phase PHASE1 Myopic Macular Degeneration ClinicalTrials.gov
    Placebo DRUG Phase PHASE2 Hypertriglyceridemia ClinicalTrials.gov
    MAR001 DRUG Phase PHASE2 Hypertriglyceridemia ClinicalTrials.gov
    STR-P004 dose group DRUG Approved Autoimmune Diseases ClinicalTrials.gov
    Pembrolizumab (KEYTRUDA®) DRUG Phase PHASE2 Metastatic Head and Neck Squamous Cell Carcinoma ClinicalTrials.gov
    Ficerafusp alfa DRUG Phase PHASE2 Metastatic Head and Neck Squamous Cell Carcinoma ClinicalTrials.gov
    CP-383 DRUG Phase PHASE1 Solid Tumor Malignancies ClinicalTrials.gov
    ART5803 DRUG Phase PHASE1 Autoimmune Encephalitis ClinicalTrials.gov
    MAR002 DRUG Phase PHASE1 Acromegaly ClinicalTrials.gov
    Dexpramipexole Dihydrochloride DRUG Phase PHASE3 Eosinophilic Asthma ClinicalTrials.gov
    STR-P004 DRUG Approved Acute Lymphobkastic Leukemia ClinicalTrials.gov
    Intravenous (IV) single dose DRUG Phase PHASE1 Prostate Cancer ClinicalTrials.gov
    CBX-12 DRUG Phase PHASE2 Platinum-resistant Ovarian Cancer ClinicalTrials.gov
    phenylacetate salt of ornithine OTHER Approved Healthy ClinicalTrials.gov
    Intravenous immunoglobulin (IVIG) DRUG Phase PHASE1 Autoimmune Encephalitis Caused by N-Methyl D-Aspartate Receptor Antibody ClinicalTrials.gov
    ATP162 DRUG Phase PHASE1 Pancreatic Ductal Adenocarcinoma ClinicalTrials.gov
    Ezabenlimab DRUG Phase PHASE1 Pancreatic Ductal Adenocarcinoma ClinicalTrials.gov
    ATP152 DRUG Phase PHASE1 Pancreatic Ductal Adenocarcinoma ClinicalTrials.gov
    ATP150 DRUG Phase PHASE1 Pancreatic Ductal Adenocarcinoma ClinicalTrials.gov
    VSV-GP154 DRUG Phase PHASE1 Pancreatic Ductal Adenocarcinoma ClinicalTrials.gov
    Sham Attention Bias Modification BEHAVIORAL Phase EARLY_PHASE1 Depression ClinicalTrials.gov
    Gamified Attention Bias Modification BEHAVIORAL Phase EARLY_PHASE1 Depression ClinicalTrials.gov
    Traditional Attention Bias Modification BEHAVIORAL Phase EARLY_PHASE1 Depression ClinicalTrials.gov
    perflutren lipid microsphere DRUG Phase PHASE1 Acute Ischemic Stroke ClinicalTrials.gov
    OrthoDerm transdermal nitroglycerin patch DRUG Phase PHASE2 Tendonitis ClinicalTrials.gov
    AEG35156 DRUG Phase PHASE1 Carcinoma, Non-Small-Cell Lung ClinicalTrials.gov
    CHR-2797 (tosedostat) DRUG Phase PHASE1 Advanced Solid Tumors ClinicalTrials.gov
    AR9281 DRUG Phase PHASE2 Hypertension ClinicalTrials.gov
    Standard of care OTHER Phase PHASE2 Diabetic Foot ClinicalTrials.gov
    GAM501 BIOLOGICAL Phase PHASE2 Diabetic Foot ClinicalTrials.gov
    AEG33773 oral dosing DRUG Phase PHASE2 Diabetic Peripheral Neuropathy ClinicalTrials.gov
    PassPort(R) Transdermal Insulin Delivery System OTHER Phase PHASE1 Type 1 Diabetes ClinicalTrials.gov
    KRN5500 DRUG Phase PHASE2 Neuropathic Pain ClinicalTrials.gov
    XIAP antisense DRUG Phase PHASE1 Leukemia, Myelomonocytic, Acute ClinicalTrials.gov
    AdF5FGF-4 vs. Placebo GENETIC Phase PHASE2 Stable Angina ClinicalTrials.gov
    CHR-3996 DRUG Phase PHASE1 Solid Tumor ClinicalTrials.gov
    Ad5FGF-4 GENETIC Phase PHASE3 Angina Pectoris ClinicalTrials.gov
    Ad5FGF-4 vs. Placebo GENETIC Phase PHASE2 Angina Pectoris ClinicalTrials.gov
    Tosedostat DRUG Phase PHASE2 Acute Myeloid Leukemia ClinicalTrials.gov
    AEG35156 antisense IV infusion DRUG Phase PHASE1 Leukemia, Lymphocytic, Chronic, B-Cell ClinicalTrials.gov
    CHR-2845 DRUG Phase PHASE1 Hematological Disease ClinicalTrials.gov
    Sorafenib DRUG Phase PHASE1 Advanced Hepatocellular Carcinoma ClinicalTrials.gov
    CHR-2797 DRUG Phase PHASE1 Solid Tumor ClinicalTrials.gov
    erlotinib DRUG Phase PHASE1 Carcinoma, Non-Small-Cell Lung ClinicalTrials.gov
    AST-120 DRUG Phase PHASE3 Inflammatory Bowel Disease ClinicalTrials.gov
    CR845 DRUG Phase PHASE2 Acute Pain ClinicalTrials.gov
    Alferminogene tadenovec GENETIC Phase PHASE3 Angina, Stable ClinicalTrials.gov
    lactulose DRUG Phase PHASE2 Hepatic Encephalopathy ClinicalTrials.gov
    Celphere® CP-305 DRUG Phase PHASE2 Irritable Bowel Syndrome ClinicalTrials.gov
    Part B: CR845 1.0 mcg/kg DRUG Phase PHASE2 Pruritus ClinicalTrials.gov
    Part B: Placebo DRUG Phase PHASE2 Pruritus ClinicalTrials.gov
    Part A: CR845 2.5 mcg/kg DRUG Phase PHASE2 Pruritus ClinicalTrials.gov
    Part A: CR845 1.0 mcg/kg DRUG Phase PHASE2 Pruritus ClinicalTrials.gov
    Part A: CR845 0.5 mcg/kg DRUG Phase PHASE2 Pruritus ClinicalTrials.gov
    Part A: Placebo DRUG Phase PHASE2 Pruritus ClinicalTrials.gov
    Celphere CP-305 DRUG Phase PHASE2 Gastroesophageal Reflux Disease (GERD) ClinicalTrials.gov
    CR845 5 mg DRUG Phase PHASE2 Osteoarthritis ClinicalTrials.gov
    CR845 1 mg DRUG Phase PHASE2 Osteoarthritis ClinicalTrials.gov
    CR845 0.50 mg DRUG Phase PHASE2 Osteoarthritis ClinicalTrials.gov
    CR845 0.25 mg DRUG Phase PHASE2 Osteoarthritis ClinicalTrials.gov
    Ornithine Phenylacetate DRUG Phase PHASE2 Acute Liver Failure ClinicalTrials.gov
    Placebo IV DRUG Phase PHASE2 Post Abdominal Surgery Pain ClinicalTrials.gov
    CR845 IV 0.5 mcg/kg DRUG Phase PHASE2 Post Abdominal Surgery Pain ClinicalTrials.gov
    CR845 IV 1 mcg/kg DRUG Phase PHASE2 Post Abdominal Surgery Pain ClinicalTrials.gov
    [14C] CR845 DRUG Phase PHASE1 Hemodialysis ClinicalTrials.gov
    CR845 1.5mcg/kg DRUG Phase PHASE2 Uremic Pruritus ClinicalTrials.gov
    CR845 1 mcg/kg DRUG Phase PHASE2 Uremic Pruritus ClinicalTrials.gov
    CR845 0.5 mcg/kg DRUG Phase PHASE2 Uremic Pruritus ClinicalTrials.gov
    Dexmecamylamine HCl DRUG Phase PHASE2 Palmar Hyperhidrosis ClinicalTrials.gov
    Tefinostat DRUG Phase PHASE1 Hepatocellular Carcinoma ClinicalTrials.gov
    Moxifloxacin 400 mg Oral Tablet DRUG Phase PHASE1 Healthy ClinicalTrials.gov
    CR845 3 mcg/kg IV DRUG Phase PHASE1 Healthy ClinicalTrials.gov
    CR845 0.5 mcg/kg IV DRUG Phase PHASE1 Healthy ClinicalTrials.gov
    grapiprant and pembrolizumab DRUG Phase PHASE1 Non-small Cell Lung Cancer Adenocarcinoma ClinicalTrials.gov
    Placebo tablet DRUG Phase PHASE2 Osteoarthritis, Hip ClinicalTrials.gov
    CR845 tablet 5 mg DRUG Phase PHASE2 Osteoarthritis, Hip ClinicalTrials.gov
    CR845 tablet 2.5 mg DRUG Phase PHASE2 Osteoarthritis, Hip ClinicalTrials.gov
    CR845 tablet 1 mg DRUG Phase PHASE2 Osteoarthritis, Hip ClinicalTrials.gov
    PEN-221 DRUG Phase PHASE1 Neuroendocrine Tumors ClinicalTrials.gov
    Niraparib DRUG Phase PHASE1 Carcinoma ClinicalTrials.gov
    Folinic acid DRUG Phase PHASE1 Carcinoma ClinicalTrials.gov
    fluorouracil DRUG Phase PHASE1 Carcinoma ClinicalTrials.gov
    PEN-866 Sodium DRUG Phase PHASE1 Carcinoma ClinicalTrials.gov
    Difelikefalin DRUG Preclinical Uremic Pruritus ClinicalTrials.gov
    difelikefalin 1.0 mg DRUG Phase PHASE2 Pruritus ClinicalTrials.gov
    difelikefalin 0.5 mg DRUG Phase PHASE2 Pruritus ClinicalTrials.gov
    difelikefalin 0.25 mg DRUG Phase PHASE2 Pruritus ClinicalTrials.gov
    LMX 4 Topical Cream DRUG Phase PHASE1 Pompe Disease ClinicalTrials.gov
    Lidocaine DRUG Phase PHASE1 Pompe Disease ClinicalTrials.gov
    Acetaminophen DRUG Phase PHASE1 Pompe Disease ClinicalTrials.gov
    Diphenhydramine DRUG Phase PHASE1 Pompe Disease ClinicalTrials.gov
    Rituxan DRUG Phase PHASE1 Pompe Disease ClinicalTrials.gov
    saline OTHER Phase PHASE1 Pompe Disease ClinicalTrials.gov
    Rapamycin DRUG Phase PHASE1 Pompe Disease ClinicalTrials.gov
    Recombinant Adeno-Associated Virus Acid Alpha-Glucosidase GENETIC Phase PHASE1 Pompe Disease ClinicalTrials.gov
    difelikefalin 2.0 mg DRUG Phase PHASE2 Pruritus ClinicalTrials.gov
    AER-901 Solution for Nebulization DRUG Phase PHASE1 Pulmonary Arterial Hypertension ClinicalTrials.gov
    CR845 1.0 mg DRUG Phase PHASE2 Cholestatic Pruritus ClinicalTrials.gov
    Placebo Oral Tablet DRUG Phase PHASE3 Chronic Kidney Diseases ClinicalTrials.gov
    Difelikefalin 1 mg Oral Tablet DRUG Phase PHASE3 Chronic Kidney Diseases ClinicalTrials.gov
    CR845 1 mg Oral Tablet DRUG Phase PHASE2 Chronic Kidney Diseases ClinicalTrials.gov
    CR845 0.5 mg Oral Tablet DRUG Phase PHASE2 Chronic Kidney Diseases ClinicalTrials.gov
    CR845 0.25 mg Oral Tablet DRUG Phase PHASE2 Chronic Kidney Diseases ClinicalTrials.gov
    FT011 DRUG Phase PHASE2 Scleroderma, Systemic ClinicalTrials.gov
    Restasis 0.05% eyedrop DRUG Phase PHASE2 Dry Eye Syndromes ClinicalTrials.gov
    SCAI-001 0.02% eyedrop DRUG Phase PHASE2 Dry Eye Syndromes ClinicalTrials.gov
    SCAI-001 0.01% eyedrop DRUG Phase PHASE2 Dry Eye Syndromes ClinicalTrials.gov
    grapiprant DRUG Phase PHASE1 Microsatellite Stable Colorectal Cancer ClinicalTrials.gov
    Vehicle Cream DRUG Phase PHASE3 Pruritus ClinicalTrials.gov
    TCS Cream DRUG Phase PHASE3 Pruritus ClinicalTrials.gov
    STR-V003/Placebo BIOLOGICAL Phase PHASE1 Respiratory Syncytial Virus Infections ClinicalTrials.gov
    human HER2-targeted CAR-M cells BIOLOGICAL Phase EARLY_PHASE1 Gastric Cancer ClinicalTrials.gov
    Placebo tablets DRUG Phase PHASE2 Pruritus ClinicalTrials.gov
    difelikefalin 0.25 mg tablets DRUG Phase PHASE2 Pruritus ClinicalTrials.gov
    difelikefalin 1.0 mg tablets DRUG Phase PHASE2 Pruritus ClinicalTrials.gov
    difelikefalin 2.0 mg tablets DRUG Phase PHASE2 Pruritus ClinicalTrials.gov
    Pembrolizumab DRUG Phase PHASE1 Head and Neck Squamous Cell Carcinoma ClinicalTrials.gov
    BCA101 DRUG Phase PHASE1 Head and Neck Squamous Cell Carcinoma ClinicalTrials.gov
    CPTX2309 DRUG Phase PHASE1 Healthy Volunteers ClinicalTrials.gov
    SCAI-005 0.08% or placebo 2drops DRUG Phase PHASE1 Wet Age Related Macular Degeneration ClinicalTrials.gov
    SCAI-005 0.08% or placebo DRUG Phase PHASE1 Wet Age Related Macular Degeneration ClinicalTrials.gov
    SCAI-005 0.04% or placebo DRUG Phase PHASE1 Wet Age Related Macular Degeneration ClinicalTrials.gov
    Val, Cel and Met XR High DRUG Phase PHASE1 Type 2 Diabetes ClinicalTrials.gov
    Val, Cel and Met XR Low DRUG Phase PHASE1 Type 2 Diabetes ClinicalTrials.gov
    Metformin DRUG Phase PHASE1 Type 2 Diabetes ClinicalTrials.gov
    AX-202 BIOLOGICAL Phase PHASE1 Healthy Volunteers ClinicalTrials.gov
    ABA-101 BIOLOGICAL Phase PHASE1 Progressive Multiple Sclerosis ClinicalTrials.gov
    VSV-GP128 DRUG Phase PHASE1 Colorectal Cancer ClinicalTrials.gov
    BI 754091 DRUG Phase PHASE1 Colorectal Cancer ClinicalTrials.gov
    ATP128 DRUG Phase PHASE1 Colorectal Cancer ClinicalTrials.gov

    💼 Business Developments:

    • Partnership
    • Acquisition
    • Licensing
    • Regulatory Approval
    • Executive Changes: Not available

    Structured Data:

    • Company Name: Cara Therapeutics
    • Ticker Symbol: CARA