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 to find a suitable dose of BI 765883 and to test whether it helps people with advanced pancreatic cancer when taken alone or together with chemotherapy

    Boehringer Ingelheim

    Metastatic pancreatic ductal adenocarcinoma (mPDAC)

    phase 1 other active

    1 trial
  2. A study to find out how healthy people tolerate a new drug called S221237.

    The George Institute

    Parkinson disease (PD)

    phase 1 other active

    1 trial
  3. A study to find out whether the medication pasireotide is absorbed and processed the same way when given under the skin using either a reusable pen or a syringe in healthy subjects

    Recordati Ireland

    Post-bariatric hypoglycaemia

    phase 1 other active

    1 trial
  4. A study to investigate a potential effect of rilzabrutinib (SAR444671) on ethinylestradiol and levonorgestrel from combined oral contraceptives in healthy female participants

    Sanofi-aventis Healthcare Pty Ltd

    Immune Thrombocytopenia Purpura

    phase 1 other active

    1 trial
  5. A study to investigate how a single dose of the drug melflufen reaches brain tumor tissue, and how it affects the tumour, in patients who are already scheduled for surgery for a returning glioblastoma

    Oncopeptides AB (publ)

    Recurrent glioblastoma

    phase 1 other active

    1 trial
  6. A study to investigate how different tablet types of balinatunfib and food will influence the absorption of balinatunfib in blood in healthy adult participants

    Sanofi-aventis Healthcare Pty Ltd

    Immune system diseases

    phase 1 other active

    1 trial
  7. A study to investigate immune challenge induced skin reactions with SAR445399, canakinumab and spesolimab compared with placebo, in healthy participants aged 18 to 55 years

    Sanofi-aventis Healthcare Pty Ltd

    Immuun system diseases

    phase 1 other active

    1 trial
  8. A study to investigate safety, tolerability, pharmacokinetics, and pharmacodynamics of surovatamig in adult participants with rheumatoid arthritis or systemic lupus erythematosus.

    AstraZeneca AB

    Systemic Lupus Erythematosus, Rheumatoid Arthritis

    phase 1 other active

    1 trial
  9. A study to investigate the bioavailability of the SAR444656 test formulation and the food effect on the SAR444656 test formulation in healthy adult participants

    Sanofi-aventis Healthcare Pty Ltd

    Healthy Volunteer

    phase 1 other active

    1 trial
  10. A study to investigate the effect of capivasertib on the pharmacokinetics of oral dextromethorphan (CYP2D6) in healthy participants

    AstraZeneca AB

    Healthy participants

    phase 1 other active

    1 trial
  11. A study to investigate the effect of oral ticagrelor on the pharmacokinetics of oral rosuvastatin when given in healthy participants

    AstraZeneca AB

    Clinical trial healthy volunteer

    phase 1 other active

    1 trial
  12. A study to investigate the pharmacokinetics and safety of a single dose of duvakitug in healthy adult participants

    Sanofi-aventis Healthcare Pty Ltd

    Healthy Volunteers

    phase 1 other active

    1 trial
  13. A study to investigate the pharmacokinetics of a combined oral contraceptive when given alone and in combination with GSK3036656 in female participants of non-childbearing potential aged 18 to 65 years of age

    GlaxoSmithKline

    Tuberculosis

    phase 1 other active

    1 trial
  14. A study to investigate the safety and efficacy of SAR446523 injected subcutaneously in adult participants with relapsed/refractory myeloma

    Sanofi-aventis Healthcare Pty Ltd

    Plasma cell myeloma refractory

    phase 1 other active

    1 trial
  15. A study to investigate the safety and pharmacological effect of a single intravenous infusion of GSK2857914 in male and female participants aged 18 to 75 with moderate to severe systemic lupus erythematosus

    GlaxoSmithKline

    Systemic Lupus Erythematosus

    phase 1 other active

    1 trial
  16. A study to investigate the safety and tolerability of Trastuzumab Deruxtecan in combination with Immunotherapy Agents with and without chemotherapy, as the first treatment option for patients with advanced HER2 over-expressing Non-Small Cell Lung Cancer.

    AstraZeneca AB

    Advanced or metastatic non-squamous non-small lung cancer (mNSCLC) with human epidermal growth factor receptor 2 (HER2) overexpression (OE)

    phase 1 other active

    1 trial
  17. A study to investigate the safety and tolerability of dostarlimab in adult participants with chronic HBV infection on nucleos(t)ide analogue (NA) treatment

    GlaxoSmithKline

    Hepatitis B, Chronic

    phase 1 other active

    1 trial
  18. A study to investigate the safety, pharmacokinetics, pharmacodynamics, and immunogenicity of a CD19/CD20 T-cell engager in participants with B-cell driven ARD.

    GlaxoSmithKline

    Systemic Lupus Erythematosus

    phase 1 other active

    1 trial
  19. A study to investigate the safety, the amount that reaches the bloodstream and the effects on the body of JNJ-64619178 in people with advanced cancers

    Janssen-Cilag International N.V.

    Previously treated lymphoma (blood cancer) or solid tumors and NHL

    phase 1 other active

    1 trial
  20. A study to investigate the safety, tolerability, pharmacokinetics, immunogenicity and pharmacodynamics of a single subcutaneous dose of GSK4771261 in healthy participants aged 25 to 55 years of age inclusive

    GlaxoSmithKline

    Autosomal Dominant Polycystic Kidney Disease

    phase 1 other active

    1 trial
  21. A study to learn BAY 3498264 when given alone or together with sotorasib in participants who have advanced solid cancers with specific genetic changes called KRASG12C mutation

    Bayer AG

    Advanced solid tumors harboring KRAS G12C mutation

    phase 1 other active

    1 trial
  22. A study to learn about how a new nurandociguat tablet is absorbed and processed in the body compared to an old tablet and how food affects the way the new tablet is absorbed and processed in the body

    Bayer AG

    Chronic Kidney Disease

    phase 1 other active

    1 trial
  23. A study to learn about how itraconazole affects the level of emodepside in the blood when emodepside is given as a new type of tablet to healthy participants

    Bayer AG

    Soil-transmitted helminth infection, Onchocerciasis (river blindness)

    phase 1 other active

    1 trial
  24. A study to learn about how much emodepside gets absorbed in the blood and how food affects its absorption when given as a new type of tablet to healthy participants

    Bayer AG

    Onchocerciasis (river blindness): is an infectious disease caused by Onchocerca volvulus, a parasitic nematode worm. The disease is contracted through the bite of an infected blackfly of the genus Simulium, which transmits third-stage infective larvae. An estimated 18 million people suffer from onchocerciasis, with 99% cases in 31 African countries, and 187 million people at risk Onchocercal dermatitis is the most common symptom of the disease, but severe visual impairment and blindness are the most severe complication, and onchocerciasis is the world’s second-leading infectious cause of blindness. Programs for the treatment and control of onchocerciasis through mass drug administration of ivermectin have been in place for over 20 years. However, they require patients to be given treatment (ivermectin) at regular intervals for the life of the adult worm (up to 15 years), making implementation extremely difficult in endemic countries. Emodepside is a registered drug for animal health, marketed by Bayer Animal Health GmbH under the name of Profender® (in combination with praziquantel) or Procox® (in combination with toltrazuril). It is a cyclooctadepsipeptide anthelmintic drug., Soil-transmitted helminth infection: Soil-transmitted helminthiasis is caused by one of the three soil-transmitted helminths (STH), Ascaris lumbricoides, Trichuris trichiura and hookworm (Ancylostoma duodenale and Necator americanus). Currently, STH still infects about 1.5 billion people worldwide, mostly in tropical and subtropical regions. Emodepside is a registered drug for animal health, marketed by Bayer Animal Health GmbH under the name of Profender® (in combination with praziquantel) or Procox® (in combination with toltrazuril). It is a cyclooctadepsipeptide anthelmintic drug.

    phase 1 other active

    1 trial
  25. A study to learn about how safe BAY 3389934 is, its suitable dose, and how it affects the participants with sepsis and coagulopathy

    Bayer AG

    Coagulopathy, Sepsis

    phase 1 other active

    1 trial
  26. A study to learn about the amount of asundexian in the blood when healthy participants take different types of asundexian tablets

    Bayer AG

    Prevention of ischemic stroke in patients post acute non-cardioembolic ischemic stroke or high-risk transient ischemic attack

    phase 1 other active

    1 trial
  27. A study to learn about the safety of BAY 3283142 in people with mild to moderate high blood pressure

    Bayer AG

    Chronic kidney disease

    phase 1 other active

    1 trial
  28. A study to learn about the study medicine called PF-08046032 in people with advanced cancers.

    Pfizer Australia Pty Ltd

    Advanced lymphomas (classic Hodgkin lymphoma [cHL], peripheral T cell lymphoma [PTCL], and diffuse large B cell lymphoma [DLBCL]), Solid tumors (eg, NSCLC, HNSCC, and melanoma)

    phase 1 other active

    1 trial
  29. A study to learn about the taste of Vericiguat given in liquid form in healthy male participants aged 18 to 45 years

    Bayer AG

    Heart failure in children

    phase 1 other active

    1 trial
  30. A study to learn how asundexian affects the amount of metformin in the blood when healthy participants take them together

    Bayer AG

    Prevention of ischemic stroke in patients after an acute non-cardioembolic ischemic stroke or high-risk transient ischemic attack in combination with antiplatelet therapy

    phase 1 other active

    1 trial
  31. A study to learn how different amounts of the study medicine called PF-07941944 are tolerated in the body of healthy adults.

    Pfizer Australia Pty Ltd

    RSV (Respiratory Syncytial Virus)

    phase 1 other active

    1 trial
  32. A study to learn how safe and tolerable odronextamab and cemiplimab are in adult patients with B-cell malignancies

    Lacuna Pharma Pty Ltd

    B-Cell Non-Hodgkin’s Lymphoma (B-NHL)

    phase 1 other active

    1 trial
  33. A study to learn how safe nurandociguat is when taken with sildenafil in men with arterial hypertension.

    Bayer AG

    Chronic Kidney Disease, Arterial hypertension

    phase 1 other active

    1 trial
  34. A study to learn how safe the study drug BAY 2416964 (AhR inhibitor) in combination with the treatment pembrolizumab is, how this combination affects the body, the maximum amount that can be given, how it moves into, through and out of the body and its action against advanced solid cancers in adults

    Bayer AG

    Advanced solid tumors

    phase 1 other active

    1 trial
  35. A study to learn how the study medicine called [14C]PF-07054894 is processed by the body.

    Pfizer Australia Pty Ltd

    Inflammatory bowel disease.

    phase 1 other active

    1 trial
  36. A study to learn how vamorolone affects the body, how safe it is and how it moves into, through and out of the body in healthy male participants

    Lacuna Pharma Pty Ltd

    Phase I study in healthy male volunteers. Intended indication: Duchenne muscular dystrophy and Becker muscular dystrophy

    phase 1 other active

    1 trial
  37. A study to learn how zilucoplan moves throughout the body over time when given in 2 different ways in healthy adults

    Lacuna Pharma Pty Ltd

    Healthy Volunteers

    phase 1 other active

    1 trial
  38. A study to learn if UCB3101 is safe and how it moves through the body of healthy participants

    Lacuna Pharma Pty Ltd

    Healthy Participants

    phase 1 other active

    1 trial
  39. A study to learn if bimekizumab given in different ways is safe and moves similarly throughout the body over time in adults

    Lacuna Pharma Pty Ltd

    CCI

    phase 1 other active

    1 trial
  40. A study to learn more about how BAY3283142 moves into, through, and out of the body of healthy participants when taken together with atazanavir and to assess the proportion of BAY3283142 that reaches the blood when taken by mouth.

    Bayer AG

    Chronic kidney disease

    phase 1 other active

    1 trial
  41. A study to learn more about how safe nurandociguat is and how it affects the way the body processes rosuvastatin and dabigatran in healthy adults

    Bayer AG

    Chronic Kidney Disease

    phase 1 other active

    1 trial
  42. A study to learn more about the safety and effects of a new blood-thinning medicine, given alone and together with another blood-thinner, in healthy adults

    Bayer AG

    atrial fibrillation, transient ischemic attack (TIA), ischemic stroke

    phase 1 other active

    1 trial
  43. A study to see how RO7763505 works and how safe it is when given to healthy people and people with stable heart disease

    Hoffmann-La Roche

    Stable Coronary Artery Disease (CAD)

    phase 1 other active

    1 trial
  44. A study to see how combination of RMC-6291 and RMC-6236 is tolerated in multiple different dosages in participants with Advanced KRASG12C-mutated Solid Tumors

    Revolution Medicines

    Participants with Advanced KRASG12C-Mutated Solid Tumors

    phase 1 other active

    1 trial
  45. A study to see the effect of NNC0194-0499 alone or in combination with semaglutide on blood sugar control in people living with type 1 diabetes.

    NovoThirteen

    Diabetes mellitus type 1

    phase 1 other active

    1 trial
  46. A study to test Aumolertinib in European participants with genetically linked advanced Lung Cancer

    Lacuna Pharma Pty Ltd

    Non-Small Cell Lung Cancer (NSCLC) with Epidermal Growth Factor Receptor (EGFR) mutations, Non-Small Cell Lung Cancer (NSCLC) with Epidermal Growth Factor Receptor (EGFR) mutations

    phase 1 other active

    1 trial
  47. A study to test BI 765179 alone and in combination with ezabenlimab in patients with advanced cancer (solid tumors) and BI 765179 in combination with pembrolizumab in patients with advanced head and neck cancer

    Boehringer Ingelheim

    Advanced head and neck cancer

    phase 1 other active

    1 trial
  48. A study to test a medicine (fitusiran) for preventing bleeds in people with severe hemophilia who previously received preventive treatment with emicizumab

    Sanofi-aventis Healthcare Pty Ltd

    Hemophilia A

    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