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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 Phase 1, Open-Label Study of the Safety, Pharmacokinetics, and Pharmacodynamics of JNJ-64264681 in Participants with Non-Hodgkin Lymphoma and Chronic Lymphocytic Leukemia

    Janssen-Cilag International N.V.

    non-Hodgkin lymphoma and chronic lymphocytic leukemia

    phase 1 other active

    1 trial

  2. A Phase 1, Open-Label Study to Investigate the TARP-ɣ8 Receptor Occupancy of RAP-219 Using a TARP-γ8 PET Tracer in Healthy Adult Participants

    Rapport Therapeutics

    Epilepsy

    phase 1 other active

    1 trial

  3. A Phase 1, Open-Label, 2-Period, 2-Formulation, Within-Subject Crossover Comparative Pharmacokinetic, Pharmacodynamic, and Safety Study of 1 Dose Level of Aspirin for Injection and Oral Aspirin Tablets in Healthy Adult Human Subjects Under Fasting Conditions.

    Lacuna Pharma Pty Ltd

    not applicable (submitted trial is a pharmacokinetic and pharmacodynamic safety study in healthy subjects)

    phase 1 other active

    1 trial

  4. A Phase 1, Open-Label, Multicenter Study of INCB123667 as Monotherapy and in Combination With Anticancer Therapies in Participants With Selected Advanced Solid Tumors

    Incyte

    Advanced or metastatic solid tumors

    phase 1 other active

    1 trial

  5. A Phase 1, Open-Label, Multicenter Study of INCB160058 in Participants With Myeloproliferative Neoplasms.

    Incyte

    Myeloproliferative Neoplasms

    phase 1 other active

    1 trial

  6. A Phase 1, Open-Label, Multicenter Study of INCB161734 in Participants With Advanced or Metastatic Solid Tumors with KRAS G12D Mutation

    Incyte

    Advanced or metastatic solid tumors

    phase 1 other active

    1 trial

  7. A Phase 1, Open-Label, Safety and Tolerability Study of INCB057643 in Participants With Myelofibrosis and Other Advanced Myeloid Neoplasms

    Incyte

    Treatment of participants with MF, MDS, ET, or MDS/MPN

    phase 1 other active

    1 trial

  8. A Phase 1, Open-label, Randomized, Crossover Study to Assess the Effect of Different Types of Co-administered Oral Liquids on the Relative Oral Bioavailability of a JNJ 77242113 Tablet Formulation in Healthy Participants.

    Janssen-Cilag International N.V.

    Inflammatory Conditions

    phase 1 other active

    1 trial

  9. A Phase 1, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Pimozide after Multiple Dose Administration in Subjects with Rheumatoid Arthritis

    Lacuna Pharma Pty Ltd

    rheumatoid arthritis

    phase 1 other active

    1 trial

  10. A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Multi-Centre Study to Assess the Safety, Tolerability, and Pharmacodynamics of AZD4144 in Participants with Established Atherosclerotic Cardiovascular and Chronic Kidney Disease

    AstraZeneca AB

    Chronic Kidney disease, Atherosclerotic Cardiovascular Disease

    phase 1 other active

    1 trial

  11. A Phase 1, Randomized, Double-Blind, Two-Arm, Two-Way Crossover Study of Pharmacokinetics and Pharmacodynamics of QL0911

    Lacuna Pharma Pty Ltd

    Immune Thrombocytopenia, Hematopoietic Syndrome of Acute Radiation Syndrome

    phase 1 other active

    1 trial

  12. A Phase 1, Randomized, Double-blind, Placebo-controlled Study Evaluating AMG 691 in Healthy Participants and Participants With Mild-to-Moderate Asthma

    Amgen

    Asthma

    phase 1 other active

    1 trial

  13. A Phase 1, Randomized, Open Label, Single-Dose Crossover Study to Assess the Relative Bioavailability, Food Effect, and Safety of Capsule Formulations of INF904.

    InflaRx GmbH

    Not applicable, healthy volunteers

    phase 1 other active

    1 trial

  14. A Phase 1, Randomized, Placebo-controlled Study with a Double-blind Period with Open-label Extension Period to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Intrathecally Administered ALN-5288 in Adult Patients with Alzheimer’s Disease

    Alnylam Netherlands B.V.

    Alzheimer’s Disease

    phase 1 other active

    1 trial

  15. A Phase 1, open label, randomized, 2-sequence, 2-period, crossover, single center study to evaluate the pharmacokinetics of follitropin alfa from 2 manufacturing processes, administered as a single subcutaneous 450 IU dose to pituitary-suppressed healthy premenopausal female participants.

    Merck Sharp and Dohme

    Infertility

    phase 1 other active

    1 trial

  16. A Phase 1/1b First-in-Human Study of BMS-986506 in ccRCC

    Bristol-Myers Squibb Australia Pty Ltd

    Advanced Clear Cell Renal Cell Carcinoma

    phase 1 other active

    1 trial

  17. A Phase 1/1b Open-Label Dose-Escalation and Dose-Optimization Study of Bcl-2 Inhibitor BGB 21447 in Patients With Mature B Cell Malignancies

    BeiGene

    mature B-Cell malignancies

    phase 1 other active

    1 trial

  18. A Phase 1a/1b Study Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Preliminary Antitumor Activity of BG-75202, Alone and in Combination with Other Agents in Patients with Advanced Solid Tumors

    BEONE MEDICINES AUS PTY LTD

    Advanced and Metastatic Solid tumors

    phase 1 other active

    1 trial

  19. A Phase 1a/1b Study Exploring the Safety and Tolerability of INCB081776 in Participants With Advanced Malignancies

    Incyte

    Advanced malignancies.

    phase 1 other active

    1 trial

  20. A Phase 1a/1b Study Investigating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Antitumor Activity of BG-60366 in Patients With EGFR-Mutant Non-Small Cell Lung Cancer

    BEONE MEDICINES AUS PTY LTD

    EGFR-Mutant Non-Small Cell Lung Cancer

    phase 1 other active

    1 trial

  21. A Phase 1a/1b Study Investigating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Antitumor Activity of BGB-A3055, Alone and in Combination With Tislelizumab in Patients With Selected Advanced or Metastatic Solid Tumors

    BeiGene

    Advanced or metastatic solid tumors

    phase 1 other active

    1 trial

  22. A Phase 1a/1b Study Investigating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Antitumor Activity of the CDK4 Inhibitor BGB-43395, Alone or as Part of Combination Therapies in Patients With Metastatic HR+/HER2- Breast Cancer and Other Advanced Solid Tumors

    BEONE MEDICINES AUS PTY LTD

    Advanced or metastatic solid tumors including hormone receptor positive (HR+), human epidermal growth factor 2 negative (HER2-) breast cancer

    phase 1 other active

    1 trial

  23. A Phase 1a/1b Study of ELVN-001 for the Treatment of Chronic Myeloid Leukemia

    Enliven Therapeutics

    Chronic myeloid leukemia

    phase 1 other active

    1 trial

  24. A Phase 1a/1b Study to Investigate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Antitumor Activity of BGB-53038, a Pan-KRAS Inhibitor, as Monotherapy or in Combinations in Patients With Advanced or Metastatic Solid Tumors With KRAS Mutations or Amplification

    BEONE MEDICINES AUS PTY LTD

    Advanced or Metastatic Solid Tumors with KRAS Mutations or Amplifications

    phase 1 other active

    1 trial

  25. A Phase 1a/1b, Open-Label Study Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Antitumor Activity of BG-75098 Alone and in Combination With Other Agents in Patients With Advanced Solid Tumors

    BEONE MEDICINES AUS PTY LTD

    Advanced, metastatic or unresectable solid tumors

    phase 1 other active

    1 trial

  26. A Phase 1a/b Study Investigating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Antitumor Activity of PRMT5 Inhibitor BGB-58067 Alone and in Combination with Anticancer Agents in Patients With Advanced Solid Tumors

    BEONE MEDICINES AUS PTY LTD

    Advanced, or metastatic solid tumors with methylthioadenosine phosphorylase (MTAP) homozygous deletion and/or lost MTAP protein expression

    phase 1 other active

    1 trial

  27. A Phase 1b Open-Label Study to Evaluate the Safety and Anti-cancer Activity of Loncastuximab Tesirine in Combination with Other Anti-cancer Agents in Patients with Relapsed or Refractory B-cell Non-Hodgkin Lymphoma (LOTIS-7)

    ADC Therapeutics SA

    Relapsed or Refractory B-cell Non-Hodgkin Lymphoma

    phase 1 other active

    1 trial

  28. A Phase 1b Study of AMG 757 in Subjects with Neuroendocrine Prostate Cancer

    Amgen

    Adult subjects with de novo or treatment-emergent neuroendocrine prostate cancer

    phase 1 other active

    1 trial

  29. A Phase 1b Study of Bispecific T Cell Redirection Antibodies in Combination with Checkpoint Inhibition for the Treatment of Participants with Relapsed or Refractory Multiple Myeloma

    Janssen-Cilag International N.V.

    Relapsed or Refractory Multiple Myeloma

    phase 1 other active

    1 trial

  30. A Phase 1b Study of JNJ-78278343, a T-cell Redirecting Agent Targeting Human Kallikrein 2 (KLK2), in Combination with either JNJ-63723283 (cetrelimab), Taxane Chemotherapy, or Androgen Receptor Pathway Inhibitors for Metastatic Prostate Cancer

    Janssen-Cilag International N.V.

    Metastatic Prostate Cancer

    phase 1 other active

    1 trial

  31. A Phase 1b Study of JNJ-79635322 with Daratumumab With or Without Lenalidomide or JNJ-79635322 with Pomalidomide for Multiple Myeloma

    Janssen-Cilag International N.V.

    Multiple Myeloma

    phase 1 other active

    1 trial

  32. A Phase 1b Study of JNJ-80948543 in Combination with Other CD3 TCEs for R/R B-cell NHL

    Janssen-Cilag International N.V.

    Relapsed/Refractory B-cell Non-Hodgkin Lymphoid Malignancies

    phase 1 other active

    1 trial

  33. A Phase 1b Study of Neoadjuvant Xaluritamig in Subjects With Newly Diagnosed Localized Intermediate or High-Risk Prostate Cancer

    Amgen

    Newly diagnosed localized Intermediate or High‐Risk Prostate Cancer

    phase 1 other active

    1 trial

  34. A Phase 1b Study of Subcutaneous Daratumumab Regimens in Combination with Bispecific T Cell Redirection Antibodies for the Treatment of Subjects with Multiple Myeloma

    Janssen-Cilag International N.V.

    Multiple myeloma

    phase 1 other active

    1 trial

  35. A Phase 1b Study of the MALT1 Inhibitor JNJ-67856633 and Ibrutinib in Combination in Relapsed or Refractory B cell Non-Hodgkin Lymphoma and Chronic Lymphocytic Leukemia

    Janssen-Cilag International N.V.

    Non-Hodgkin lymphoma and chronic lymphocytic leukemia

    phase 1 other active

    1 trial

  36. A Phase 1b open label pilot study of CLN-978 for the treatment of moderate to severe systemic lupus erythematosus (SLE)

    Cullinan Therapeutics

    Systemic Lupus Erythematosus

    phase 1 other active

    1 trial

  37. A Phase 1b, Double-Blind Study to Investigate Safety, Tolerability, Pharmacokinetics, Efficacy, and Pharmacodynamics of Single Dose of ATI-052 in Participants with Mild to Moderate Asthma

    Aclaris Therapeutics

    Mild to Moderate Asthma

    phase 1 other active

    1 trial

  38. A Phase 1b, Multicenter Study to Determine the Dose, Safety, Efficacy and Pharmacokinetics of TRK-950 when Used in Combinations with Selected Anti-Cancer Treatment Regimens in Patients with Selected Advanced Solid Tumors

    Toray International U.K. Limited

    Bladder cancer, Cholangiocarcinoma, Colorectal Cancer, Epithelial Ovarian Cancer, Fallopian Tube Cancer, Gastric Cancer, Melanoma, Ovarian Cancer, Palpable Subcutaneous Malignant Lesions, Primary Peritoneal Cancer, Renal Cell Carcinoma, Solid Tumor

    phase 1 other active

    1 trial

  39. A Phase 1b, Multicenter, Open-label Study of Acalabrutinib in Combination with Bendamustine and Rituximab (BR) or Venetoclax and Rituximab (VR) in Subjects with Mantle Cell Lymphoma

    Lacuna Pharma Pty Ltd

    Mantle Cell Lymphoma

    phase 1 other active

    1 trial

  40. A Phase 1b, Open-Label Study of CLN-978 for the Treatment of Active, Moderate to Severe Sjogren’s Disease

    Cullinan Therapeutics

    Sjogren's Disease

    phase 1 other active

    1 trial

  41. A Phase 1b, Open-Label Study of Eftozanermin Alfa (ABBV-621) in Combination with Bortezomib and Dexamethasone in Subjects with Relapsed or Refractory Multiple Myeloma

    AbbVie Deutschland GmbH & Co. KG

    Multiple Myeloma

    phase 1 other active

    1 trial

  42. A Phase 1b, Open-Label Study of the Safety, Pharmacokinetics, and Pharmacodynamics of JNJ-64264681 in Combination with JNJ-67856633 in Participants with Non-Hodgkin Lymphoma and Chronic Lymphocytic Leukemia

    Janssen-Cilag International N.V.

    non-Hodgkin lymphoma and chronic lymphocytic leukemia

    phase 1 other active

    1 trial

  43. A Phase 1b/2 Study of JNJ-90014496 in Adult Participants with B-cell Non-Hodgkin Lymphoma

    Janssen-Cilag International N.V.

    Non-Hodgkin Lymphoid Malignancies

    phase 1 other active

    1 trial

  44. A Phase I First Time in Human Open Label Study of GSK3745417 Administered With and Without Anticancer Agents in Participants With Advanced Solid Tumors

    GlaxoSmithKline

    Neoplasms

    phase 1 other active

    1 trial

  45. A Phase I Interventional Open-Label, Non-Randomized Dose-Escalation Trial to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, Immunogenicity, and Preliminary Anti-Tumor Activity of Autologous p95HER2.CAR-TECH2Me T Cells in Patients with Selected Advanced Cancers. Catherine Trial

    The George Institute

    Locally advanced, recurrent, or metastatic breast, gastric, endometrial, and selected other solid tumors with positive expression for HER-2 (3+)

    phase 1 other active

    1 trial

  46. A Phase I Interventional Open-Label, Non-Randomized Dose-Escalation Trial to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, Immunogenicity, and Preliminary Anti-Tumor Activity of Autologous p95HER2.CAR-TECH2Me T Cells in Patients with Selected Advanced Cancers. Catherine Trial

    The George Institute

    Locally advanced, recurrent, or metastatic breast, gastric, endometrial, and selected other solid tumors with positive expression for HER-2 (3+)

    phase 1 other active

    1 trial

  47. A Phase I Randomized, Single-center, Double-blind, Two-period Crossover Trial to Evaluate Pharmacodynamics, Pharmacokinetics, Safety, and Tolerability of Insulin GZR4 Compared with Insulin Icodec in Participants with Type 2 Diabetes.

    Lacuna Pharma Pty Ltd

    Type 2 Diabetes Mellitus

    phase 1 other active

    1 trial

  48. A Phase I Study of BMS-986497 alone or in combination with Azacitidine (Aza) and Azacitidine plus Venetoclax (AZA+VEN) in relapsed or refractory (R/R) AML or MDS

    Bristol-Myers Squibb Australia Pty Ltd

    Acute Myeloid Leukemia and Myelodysplastic Syndrome

    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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