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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 randomized, two-way, crossover, two parallel groups study to compare the bioavailability of 150 mg and 300 mg trazodone hydrochloride tablets (new polymer) (Angelini Pharma S.p.A.) vs. 150 mg and 300 mg trazodone hydrochloride Contramid® tablets (Angelini Pharma S.p.A.) at steady-state

    Lacuna Pharma Pty Ltd

    Intended indication: Major Depressive Disorders with and without anxiety, Healthy volunteers, therapeutic indication not studied

    phase 1 other active

    1 trial

  2. A research study Looking into blood levels of the medicine NNC0519-0130 in the body of participants with normal or reduced kidney function

    NovoThirteen

    Type 2 Diabetes Mellitus

    phase 1 other active

    1 trial

  3. A research study comparing different ways of increasing the dose of NNC0519-0130 in participants with overweight or obesity

    NovoThirteen

    Type 2 diabetes mellitus

    phase 1 other active

    1 trial

  4. A research study investigating the effect of NNC0497-0040 in healthy participants, participants with overweight or obesity, and participants with type 1 diabetes with overweight or obesity.

    NovoThirteen

    Type I diabetes

    phase 1 other active

    1 trial

  5. A research study looking at how NNC0487-0111 affects food intake, appetite and metabolism after meals in people with obesity

    NovoThirteen

    Participants with obesity, but otherwise healthy

    phase 1 other active

    1 trial

  6. A research study looking at how different doses of study medicine (Inno8) work in the body of people with haemophilia A

    NovoThirteen

    Haemophilia A with or without inhibitors. Proposed indication under development: prevention of bleeding and long-term prophylaxis in patients with haemophilia A, irrespective of inhibitor status or severity.

    phase 1 other active

    1 trial

  7. A research study looking at how different doses of study medicine (Inno8) works in the body of healthy men.

    NovoThirteen

    Prophylaxis and on-demand treatment respectively in patients with haemophilia A with or without FVIII inhibitors.

    phase 1 other active

    1 trial

  8. A research study looking into blood levels of the medicine NNC0487 0111 in the body and how well it is tolerated in people with reduced liver function and normal liver function

    NovoThirteen

    hepatic impairment

    phase 1 other active

    1 trial

  9. A research study looking into how cagrilintide influences food intake and appetite in people with overweight or obesity

    NovoThirteen

    Obesity

    phase 1 other active

    1 trial

  10. A research study looking into the effect of NNC05190130 on blood levels of a birth control pill and emptying of the stomach in women after menopause

    NovoThirteen

    Healthy postmenopausal females (Type 2 Diabetes)

    phase 1 other active

    1 trial

  11. A research study of a new medicine (NNC0650-0013) in healthy men

    NovoThirteen

    Weight management, Diabetes mellitus type 2; healthy subjects

    phase 1 other active

    1 trial

  12. A research study of a new medicine NNC0363-1063 in healthy participants and participants with type 1 diabetes

    NovoThirteen

    Type 1 diabetes mellitus

    phase 1 other active

    1 trial

  13. A research study of a new medicine NNC0363-1063 in participants with type 1 diabetes

    NovoThirteen

    Diabetes type 1

    phase 1 other active

    1 trial

  14. A research study of a new medicine, NNC9733-0001, in healthy participants and participants with type 2 diabetes

    NovoThirteen

    Healthy Participants and Participants with type 2 diabetes

    phase 1 other active

    1 trial

  15. A research study of how safe a new medicine called NNC0519‑0130 is and to test its effect in people living with excess body weight with or without type 2 diabetes

    NovoThirteen

    Obesity, Type 2 Diabetes with either overweight or obesity

    phase 1 other active

    1 trial

  16. A research study on the effects of NNC0537-1482 in healthy individuals when injected under the skin.

    NovoThirteen

    Heart Failure

    phase 1 other active

    1 trial

  17. A research study to compare blood levels of cagrilintide after multiple doses of different versions of cagrilintide in adults with overweight or obesity

    NovoThirteen

    obesity

    phase 1 other active

    1 trial

  18. A research study to evaluate the effects of single doses of NNC0614-0001 in healthy adult volunteers, and participants with hereditary haemochromatosis type 1.

    NovoThirteen

    Hereditary haemochromatosis (HH) type 1

    phase 1 other active

    1 trial

  19. A research study to evaluate the safety of NNC1679-0001 when given to healthy participants and participants with T2DM

    NovoThirteen

    Healthy participants and participants with type 2 diabetes

    phase 1 other active

    1 trial

  20. A research study to look at how CagriSema influences food intake, appetite and emptying of the stomach in people with excess body weight

    NovoThirteen

    Obesity

    phase 1 other active

    1 trial

  21. A research study to look at the distribution and effects of coramitug on amyloid deposits in heart tissue using PET/CT imaging in people with ATTR amyloidosis

    NovoThirteen

    transthyretin amyloid amyloidosis cardiomyopathy (ATTR-CM)

    phase 1 other active

    1 trial

  22. A research study to see how NNC0487-0111 affects the body’s energy use after a weight loss in adults living with obesity, compared to a low-calorie diet or placebo

    NovoThirteen

    Obesity

    phase 1 other active

    1 trial

  23. A single and multiple ascending dose study of topical ladarixin ophthalmic solution in healthy volunteers

    Dompe' Farmaceutici S.p.A.

    Ocular inflammatory conditions

    phase 1 other active

    1 trial

  24. A single dose, randomized, double-blind 2-arm parallel-group study to compare the pharmacokinetics, immunogenicity, and safety for PB016 versus US-licensed Entyvio® after subcutaneous administration in healthy participants

    Lacuna Pharma Pty Ltd

    Not applicable, healthy volunteers

    phase 1 other active

    1 trial

  25. A single-dose, open-label, randomized, two-period, two-sequence, crossover pivotal bioequivalence study on 400 mg / 5 mL amoxicillin + 57 mg / 5 mL of clavulanic acid powder for oral suspension in healthy volunteers under fed conditions.

    Zaklady FarmaFarmaceutyczne Polpharma S.Aceutyczne Polpharma S.A.

    infection

    phase 1 other active

    1 trial

  26. A single-dose, open-label, randomized, two-period, two-sequence, crossover pivotal bioequivalence study on Dapagliflozin 10 mg film-coated tablets (Polfa Tarchomin S.A., Poland) versus Froxiga 10 mg film-coated tablets (AstraZeneca AB, Sweden) in healthy volunteers under fasting conditions.

    Zaklady FarmaFarmaceutyczne Polpharma S.Aceutyczne Polpharma S.A.

    intended for treatment of for the treatment of (2): • insufficiently controlled type 2 diabetes mellitus as an adjunct to diet and exercise. • symptomatic chronic heart failure. • chronic kidney disease.

    phase 1 other active

    1 trial

  27. A single-dose, open-label, randomized, two-period, two-sequence, crossover pivotal bioequivalence study on Taromentin® 500 mg + 125 mg film-coated tablets versus Augmentin® 500 mg + 125 mg film-coated tablets in healthy volunteers under fed conditions.

    Zaklady FarmaFarmaceutyczne Polpharma S.Aceutyczne Polpharma S.A.

    infections

    phase 1 other active

    1 trial

  28. A single-dose, open-label, randomized, two-period, two-sequence, crossover pivotal bioequivalence study on two amoxicillin-clavulanic acid film-coated tablet formulations in healthy volunteers under fed conditions.

    Zaklady FarmaFarmaceutyczne Polpharma S.Aceutyczne Polpharma S.A.

    infections

    phase 1 other active

    1 trial

  29. A single-dose, randomized, two-period, two-sequence, crossover comparative bioavailability study on formulations containing ramipril, amlodipine and indapamide in combination product versus Triatec® 10 mg capsules (Sanofi - Produtos Farmacêuticos, Lda., Portugal), containing ramipril, Norvasc® 10 mg, tablets (Upjohn EESV, the Netherlands), containing amlodipine and Natrilix® 2.5 mg film-coated tablets (Les Laboratoires Servier, France), containing indapamide co-administered together as reference in healthy

    Lacuna Pharma Pty Ltd

    hypertension

    phase 1 other active

    1 trial

  30. A single-dose, randomized, two-period, two-sequence, crossover pilot bioequivalence study on formulations containing rivaroxaban and acetylsalicylic acid in healthy volunteers under fasting conditions.

    s.r.o.

    increased blood clotting

    phase 1 other active

    1 trial

  31. A study comparing different RO7269162 capsules and investigating the effect of food on the uptake, breakdown, and elimination of RO7269162 in Healthy Participants

    Hoffmann-La Roche

    Not Applicable

    phase 1 other active

    1 trial

  32. A study comparing the new drug PG413 produced by Celon Pharma SA with the drug Eliquis available on the market in healthy volunteers.

    Lacuna Pharma Pty Ltd

    Prevention of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation (NVAF), with one or more risk factors, such as prior stroke or transient ischaemic attack (TIA); age≥ 75 years; hypertension; diabetes mellitus; symptomatic heart failure (NYHA Class ≥ II). Treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), and prevention of recurrent DVT and PE in adults.

    phase 1 other active

    1 trial

  33. A study for GSK3862995B in healthy participants and participants with Chronic Obstructive Pulmonary Disease

    GlaxoSmithKline

    Pulmonary Disease, Chronic Obstructive

    phase 1 other active

    1 trial

  34. A study in healthy men and women to test how BI 3000202 is taken up and processed by the body

    Boehringer Ingelheim

    Healthy volunteer trial

    phase 1 other active

    1 trial

  35. A study in healthy men and women to test whether BI 1569912 influences the amount of repaglinide, midazolam and bupropion in the blood

    Boehringer Ingelheim

    Healthy volunteer trial

    phase 1 other active

    1 trial

  36. A study in healthy men to compare the amount of vicadrostat and empagliflozin in the blood when taken separately and together

    Boehringer Ingelheim

    Healthy volunteer trial

    phase 1 other active

    1 trial

  37. A study in healthy men to find out how different doses of BI 3009947 are tolerated and how different formulations or food influence how BI 3009947 is taken up into the blood

    Boehringer Ingelheim

    Healthy volunteer trial

    phase 1 other active

    1 trial

  38. A study in healthy men to learn about how the body absorbs, processes, and removes radioactively labeled BAY 3283142

    Bayer AG

    Chronic kidney disease

    phase 1 other active

    1 trial

  39. A study in healthy men to test how BI 1569912 is processed in the body

    Boehringer Ingelheim

    Healthy volunteer trial

    phase 1 other active

    1 trial

  40. A study in healthy men to test how BI 1584862 is processed in the body

    Boehringer Ingelheim

    Healthy volunteer trial

    phase 1 other active

    1 trial

  41. A study in healthy men to test how BI 1839100 is taken up and handled by the body

    Boehringer Ingelheim

    Healthy volunteer trial

    phase 1 other active

    1 trial

  42. A study in healthy men to test how bosentan influences the amount of nerandomilast in the blood

    Boehringer Ingelheim

    Healthy volunteer trial

    phase 1 other active

    1 trial

  43. A study in healthy men to test how bosentan influences the amount of zongertinib in the blood

    Boehringer Ingelheim

    Healthy volunteer trial

    phase 1 other active

    1 trial

  44. A study in healthy men to test how different doses of BI 3031185 are tolerated and how food influences the amount of BI 3031185 in the blood

    Boehringer Ingelheim

    Healthy volunteer trial

    phase 1 other active

    1 trial

  45. A study in healthy men to test how itraconazole influences the amount of BI 764198 in the blood

    Boehringer Ingelheim

    Healthy volunteer trial

    phase 1 other active

    1 trial

  46. A study in healthy men to test how well different doses of BI 3731579 are tolerated

    Boehringer Ingelheim

    Healthy volunteer trial

    phase 1 other active

    1 trial

  47. A study in healthy men to test how well different doses of BI 3776528 are tolerated

    Boehringer Ingelheim

    Healthy volunteer trial

    phase 1 other active

    1 trial

  48. A study in healthy men to test how well different doses of BI 3821001 are tolerated

    Boehringer Ingelheim

    Healthy volunteer trial

    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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