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Intelligence · Clinical Pipeline

Phase I Pipeline Programs

First-in-human and early clinical safety studies in Phase I.

Programs
4,713

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NovaPharmaNews tracks 4,713 phase i pharmaceutical pipeline programs from ClinicalTrials.gov. First-in-human and early clinical safety studies in Phase I.

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  1. A study of ASP3082 in adults with advanced solid tumors

    Astellas Pharma GmbH

    Solid Tumor

    phase 1 other active

    1 trial

  2. A study of LOXO-783 in Patients with PIK3CA H1047R-Mutant Advanced Breast Cancer and Other Solid Tumors.

    Eli Lilly Co.

    Advanced Breast Cancer and Other Solid Tumors

    phase 1 other active

    1 trial

  3. A study of different dose levels of FluBHPVE6E7 or placebo in women infected with the virus Human Papilloma Type 16 (HPV 16).

    Blue Earth Diagnostics Ireland Ltd

    Treatment of human papilloma virus (HPV) associated infections, precancers and cancers

    phase 1 other active

    1 trial

  4. A study of gilteritinib in adults with advanced ALK-positive non-small cell lung cancer (NSCLC)

    Astellas Pharma GmbH

    Locally advanced or metastatic NSCLC

    phase 1 other active

    1 trial

  5. A study of how CagriSema works on appetite in people with excess body weight

    NovoThirteen

    Obesity

    phase 1 other active

    1 trial

  6. A study of safety and efficacy of novel targeted therapy combinations in adult patients with advanced or metastatic colorectal cancer.

    Novartis Pharmaceuticals

    Advanced or metastatic BRAF V600 colorectal cancer.

    phase 1 other active

    1 trial

  7. A study of the PAN-KRAS inhibitor LY4066434 in participants with KRAS mutant solid tumors.

    Eli Lilly Co.

    Pancreatic Ductal Adenocarcinoma, Non-small Cell Lung Cancer, Colorectal Cancer, Advanced Solid Tumor Metastatic Solid Tumor, PanKRAS.

    phase 1 other active

    1 trial

  8. A study of the safety, tolerability, biological effect, and efficacy of allogenic natural killer cells in combination with trastuzumab and pertuzumab in adult patients with refractory metastatic Her2 positive breast cancer

    The George Institute

    Refractory metastatic Her2 positive breast cancer

    phase 1 other active

    1 trial

  9. A study on the safety of and immune response to different doses of an mRNA vaccine against RSV in healthy adults.

    GlaxoSmithKline

    Respiratory Syncytial Virus Infections

    phase 1 other active

    1 trial

  10. A study on the safety, tolerability, and effectiveness of the new drug LAD106 in healthy volunteers.

    Almirall, S.A.

    Inflammatory diseases

    phase 1 other active

    1 trial

  11. A study to Evaluate AB308 in Combination with AB122 in Participants with Advanced Malignancies (ARC-12)

    Arcus Biosciences

    Multiple Myeloma, Diffuse large B cell lymphoma (DLBCL), Esophageal Cancer, Gastroesophageal Junction Adenocarcinoma, Melanoma, Advanced Solid Tumor, Gastrointestinal (GI) cancer, Hematological (heme) cancer, Gynecological (Gyn) cancer, Non-small cell lung cancer (NSCLC), Non-Hodgkin Lymphoma, Gastric Cancer, Cervical Cancer

    phase 1 other active

    1 trial

  12. A study to Learn How Safe AGMB-129 is in Healthy Adults Taking Multiple Doses of AGMB-129 That Are Increased a Little at a Time

    Agomab Therapeutics NV

    Fibrostenotic Crohn’s disease

    phase 1 other active

    1 trial

  13. A study to Learn If Study Medicines Called Cyclosporine and Clarithromycin Affect How the Body Processes the Other Study Medicine Called PF-07328948 in Healthy Adults.

    Pfizer Australia Pty Ltd

    Heart Failure

    phase 1 other active

    1 trial

  14. A study to assess how radium-223 moves through the patients with prostate cancer receiving radium-223 dichloride treatment.

    Bayer AG

    Prostate cancer

    phase 1 other active

    1 trial

  15. A study to assess safety and efficacy of SOT201 in patients with advance/metastatic cancer

    IO Biotech

    advanced/metastatic solid tumors

    phase 1 other active

    1 trial

  16. A study to assess the effect of CC-95251 alone and in combination with anti-cancer drugs in subjects with Acute Myeloid Leukemia and Myelodysplastic Syndromes

    Celgene Europe Limited

    Acute Myeloid Leukemia and Myelodysplastic Syndromes

    phase 1 other active

    1 trial

  17. A study to assess the effect of gemfibrozil, itraconazole and phenytoin on levels of IPN60250 in the blood of healthy adult participant.

    Ipsen

    Not applicable

    phase 1 other active

    1 trial

  18. A study to assess the effect of single and repeated doses of JNJ-81241459 on a single dose of certain other drugs, when given together to healthy adult participants

    Janssen-Cilag International N.V.

    Plaque Psoriasis

    phase 1 other active

    1 trial

  19. A study to assess the effects of efgartigimod on emasiprubart in healthy adult participants

    argenx

    not applicable

    phase 1 other active

    1 trial

  20. A study to assess the pharmacokinetics, and glucodynamics of LY3209590 in participants with type 2 diabetes

    Eli Lilly Co.

    Type 2 Diabetes Mellitus

    phase 1 other active

    1 trial

  21. A study to assess the safety and tolerability of next-generation neoantigen-selected Tumor-infiltrating Lymphocyte (TIL) therapy. NEXTGEN-TIL-ACT

    The George Institute

    Advanced epithelial tumors and immune checkpoint blockade (ICB) resistant solid tumors

    phase 1 other active

    1 trial

  22. A study to assess the safety of ARGX-121 in Healthy Adult Participants

    argenx

    Healthy volunteers

    phase 1 other active

    1 trial

  23. A study to assess the safety, and blood levels of CTX-187 after single and repeated intravenous doses in healthy volunteers and patients with bacterial infection

    Centauri Biotech SL

    Bacterial Infection

    phase 1 other active

    1 trial

  24. A study to assess the safety, tolerability and pharmacokinetics of tideglusib in subjects with hepatic impairment compared to healthy subjects.

    Lacuna Pharma Pty Ltd

    Hepatic impairment, Healthy subjects

    phase 1 other active

    1 trial

  25. A study to characterise the safety, tolerability and efficacy of LY3962673 in subjects with advanced solid tumors.

    Eli Lilly Co.

    KRAS G12D-mutant solid tumors.

    phase 1 other active

    1 trial

  26. A study to characterise the safety, tolerability and efficacy of LY4170156 in subjects with advanced solid tumors

    Eli Lilly Co.

    Ovarian cancer, endometrial cancer, cervical cancer, non-small cell lung cancer, triple-negative breast cancer, pancreatic cancer and colorectal cancer.

    phase 1 other active

    1 trial

  27. A study to characterize the pharmacokinetic profile of norucholic acid (NCA) in patients with primary sclerosing cholangitis (PSC)

    Dr. Falk Pharma GmbH

    Primary Sclerosing Cholangitis (PSC)

    phase 1 other active

    1 trial

  28. A study to characterize the safety, efficacy, pharmacokinetics of subcutaneous administration of Etentamig (ABBV-383) in patients with relapsed or refractory Multiple Myeloma

    AbbVie Deutschland GmbH & Co. KG

    Relapsed or Refractory Multiple Myeloma (R/R MM)

    phase 1 other active

    1 trial

  29. A study to compare Onivyde manufactured at two different production sites in adult participants with advanced cancer in the pancreas

    Ipsen

    Metastatic Pancreatic Adenocarcinoma

    phase 1 other active

    1 trial

  30. A study to compare how different medicines (rosuvastatin, digoxin, metformin, and furosemide) are handled by the body of healthy people and people with liver cirrhosis

    Boehringer Ingelheim

    1. Patients with compensated liver cirrhosis due to any underlying liver disease with advanced fibrosis (F4) and hepatic impairment that meets the criteria for Child-Pugh A 2. Patients with decompensated liver cirrhosis due to any underlying liver disease with advanced fibrosis (F4) and hepatic impairment that meets the criteria for Child-Pugh B

    phase 1 other active

    1 trial

  31. A study to compare how different substances (caffeine, warfarin, omeprazole, metoprolol, and midazolam) are handled by the body of healthy people and people with liver cirrhosis

    Boehringer Ingelheim

    1. Patients with compensated liver cirrhosis due to any underlying liver disease with advanced fibrosis (F4) and hepatic impairment that meets the criteria for Child-Pugh A 2. Patients with decompensated liver cirrhosis due to any underlying liver disease with advanced fibrosis (F4) and hepatic impairment that meets the criteria for Child-Pugh B

    phase 1 other active

    1 trial

  32. A study to compare how the body absorbs different formulations of a new medicine, and how food affects drug absorption, in healthy participants

    Janssen-Cilag International N.V.

    Psoriasis

    phase 1 other active

    1 trial

  33. A study to compare the Pharmacokinetics, Pharmacodynamic, Immunogenicity, and Safety of CKD-706 with US-Dupixent®, and EU-Dupixent® in Healthy Adult Participants.

    Lacuna Pharma Pty Ltd

    Phase I study in healthy participants. Intended indication: atopic dermatitis, asthma, chronic rhinosinusitis with nasal polyposis, eosinophilic esophagitis, prurigo nodularis, and chronic obstructive pulmonary disease

    phase 1 other active

    1 trial

  34. A study to compare the amount of milvexian in blood when given as pediatric and adult tablet formulations, to assess the effect of food intake on the absorption of pediatric milvexian tablet formulation in healthy adult participants and to assess the acceptability of different milvexian formulations.

    Janssen-Cilag International N.V.

    atherothrombotic and thromboembolic disorders

    phase 1 other active

    1 trial

  35. A study to compare the pharmacokinetics of salbutamol administered via metered dose inhalers containing propellants HFA-152a (test) or HFA-134a (reference) in healthy participants aged 18 to 55 inclusive.

    GlaxoSmithKline

    Healthy volunteers

    phase 1 other active

    1 trial

  36. A study to compare the relative potency of salbutamol administered via metered dose inhalers containing propellants HFA-152a to HFA-134a in mild asthmatics aged 18 to 65 inclusive.

    GlaxoSmithKline

    Mild Asthma

    phase 1 other active

    1 trial

  37. A study to compare two different aramchol formulations in healthy volunteers.

    Galmed Pharmaceuticals

    Nonalcoholic fatty liver disease, Nonalcoholic steatohepatitis, Primary sclerosing cholangitis

    phase 1 other active

    1 trial

  38. A study to determine if BHV-2100 and BHV-7000 are effective, safe, and tolerable as a pain medication in healthy male participants

    Biohaven Bioscience Ireland Limited

    Pain

    phase 1 other active

    1 trial

  39. A study to establish the bioequivalence of free acid tafamidis 61 mg capsule and tablet, and evaluate the safety and tolerability of the 61 mg tablet in healthy adults

    Pfizer Australia Pty Ltd

    Transthyretin amyloidosis

    phase 1 other active

    1 trial

  40. A study to evaluate how the body absorbs, breaks down and removes drug as well as safety and tolerability when two drugs are administered together as an injection under the skin to healthy participants.

    Janssen-Cilag International N.V.

    Healthy Volunteers

    phase 1 other active

    1 trial

  41. A study to evaluate how well single and multiple doses of O3R-5671-PRO are tolerated in healthy adult subjects

    Lacuna Pharma Pty Ltd

    Inflammatory bowel diseases and psoriasis.

    phase 1 other active

    1 trial

  42. A study to evaluate the Safety, Tolerability, Pharmacokinetics (PK), Pharmacodynamics (PD), and preliminary Anti-Tumor activity of RO7616789 in participants with Advanced Small Cell Lung Cancer and other Neuroendocrine Carcinomas

    Hoffmann-La Roche

    Small Cell Lung Cancer and Neuroendocrine Carcinoma

    phase 1 other active

    1 trial

  43. A study to evaluate the effects and safety of INCA033989 in participants with myelofibrosis or essential thrombocythemia

    Incyte

    Myeloproliferative Neoplasms

    phase 1 other active

    1 trial

  44. A study to evaluate the safety and tolerability of JNJ-70035108 and to evaluate how long JNJ-70035108 stays in and acts on the body (pharmacokinetics) when given as single and repeated doses to healthy participants

    Janssen-Cilag International N.V.

    Inflammatory Conditions

    phase 1 other active

    1 trial

  45. A study to evaluate the safety and tolerability of JNJ-90106848 and to investigate how long JNJ-90106848 stays in and acts on the body (pharmacokinetics) and how the body responds to JNJ-90106848 (pharmacodynamics) when injected into healthy volunteer participants

    Janssen-Cilag International N.V.

    Inflammatory Conditions

    phase 1 other active

    1 trial

  46. A study to evaluate the safety and tolerability of single ascending doses of AGMB-101 in healthy participants (Part A) and patients with liver cirrhosis (Part B).

    Agomab Therapeutics NV

    liver cirrhosis

    phase 1 other active

    1 trial

  47. A study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of GSK4771261 in healthy participants and participants with autosomal dominant polycystic kidney disease.

    GlaxoSmithKline

    Kidney Disease

    phase 1 other active

    1 trial

  48. A study to find a suitable dose of ASP5834 in adults with solid tumors

    Astellas Pharma GmbH

    Locally advanced (unresectable) or metastatic solid tumor malignancies who harbor a KRAS mutation (G12V, G12D, G12C, G12A, G12R or G13D mutation) or KRAS amplification

    phase 1 other active

    1 trial

Frequently asked questions

How many Phase I pipeline programs are in the directory?

4,713 published programs match this development stage in our ClinicalTrials.gov index.

What defines this pipeline stage?

Phase and status reflect ClinicalTrials.gov registry fields at last sync. See our clinical trial phases reference for methodology.

Data attribution: Data sources · All pipeline programs

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