Intelligence · Clinical Pipeline

Phase I Pipeline Programs

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

Programs: 4,713

Quick answer

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

Top sponsors

Study of EGF816 in combination with selected targeted agents in EGFR-mutant NSCLC.

Novartis Pharmaceuticals

Patients with EGFR-mutant Non Small Cell Lung Cancer

phase 1 other active

1 trial
Study of GS-0151 in Participants With Rheumatoid Arthritis

Gilead Sciences Pty Limited

Rheumatoid Arthritis

phase 1 other active

1 trial
Study of GS-5319 in Adults With Solid Tumors

Gilead Sciences Pty Limited

Advanced solid tumors

phase 1 other active

1 trial
Study of JNJ-74856665 in patients with Acute Myeloid Leukemia or Myelodysplastic Syndrome

Janssen-Cilag International N.V.

Acute myeloid leukemia or Myelodysplastic syndrome

phase 1 other active

1 trial
Study of MK-4830 as Monotherapy and in Combination With Pembrolizumab (MK-3475) in Participants With Advanced Solid Tumors (MK-4830-001)

Merck Sharp and Dohme

Advanced Pancreatic cancer, Unresectable Glioblastoma and Variants, PD-1-exposed Advanced/Met HNSCC, Advanced/Met HNSCC, Advanced/Met NSCLC, Advance/Met RCC, Advanced/Met Gastric or GEJ adenocarcinoma, Ovarian Cancer. TNBC, Advanced Mesothelioma, Advanced Solid tumors(coformulation)

phase 1 other active

1 trial
Study of PIT565 in relapsed and/or refractory B-cell malignancies

Novartis Pharmaceuticals

Relapsed and/or refractory B-cell Non-Hodgkin lymphoma (R/R B-NHL) and relapsed and/or refractory B-cell acute lymphoblastic leukemia (R/R B-ALL)

phase 1 other active

1 trial
Study of REGN6569 and Cemiplimab in Adult Patients with Advanced Solid Tumor Malignancies

Lacuna Pharma Pty Ltd

Squamous Cell Carcinoma of Head and Neck

phase 1 other active

1 trial
Study of Repotrectinib and CYP450 probe Cocktail in Patients with locally advanced or Metastatic Tyrosine Kinase Inhibitors (TKI)-Pretreated ROS1-Positive Non-small Cell Lung Cancer (NSCLC)

Bristol-Myers Squibb Australia Pty Ltd

Non-small Cell Lung Cancer (NSCLC)

phase 1 other active

1 trial
Study of Safety, Tolerability, Pharmacodynamics and Pharmacokinetics of NIO752 in Early Alzheimer's Disease Participants

Novartis Pharmaceuticals

Alzheimer’s Disease

phase 1 other active

1 trial
Study of TSR-022, a Monoclonal Antibody, in Patients with Advanced Solid Tumors

TESARO Bio Netherlands B.V.

Patients with Advanced Solid Tumors

phase 1 other active

1 trial
Study of U3-1402 in subjects with non-small cell lung cancer

Daiichi Sankyo

METASTATIC OR UNRESECTABLE NON-SMALL CELL LUNG CANCER

phase 1 other active

1 trial
Study of diclofenac skin reservoir formation and emptying after Voltaren Emulgel 2.32% application in healthy participants

HALEON AUSTRALIA PTY LTD

For the local, symptomatic treatment of pain in acute bruises, strains, or sprains due to blunt trauma, e.g., sports and accident injuries

phase 1 other active

1 trial
Study of safety and antitumor activity of GEN1056 in participants with advanced solid tumors

Genmab A/S

Advanced solid tumors

phase 1 other active

1 trial
Study of safety and efficacy of DKY709 alone or in combination with PDR001 in patients with advanced solid tumors.

Novartis Pharmaceuticals

Nasopharyngeal Carcinoma, Triple Negative Breast Cancer, Microsatellite Stable Colorectal Cancer, Non-Small Cell Lung Cancer, Cutaneous Melanoma

phase 1 other active

1 trial
Study of safety and preliminary efficacy of VAY736 given alone or in combination with other antineoplastic agents in patients with NHL

Novartis Pharmaceuticals

Relapsed/refractory Non Hodgkin Lymphoma

phase 1 other active

1 trial
Study to Evaluate Adverse Events, Change in Disease Activity, and How Intravenously Infused ABBV-291 Moves Through the Body in Adult Participants With Non-Hodgkin's Lymphoma

AbbVie Deutschland GmbH & Co. KG

Non-Hodgkin's Lymphoma

phase 1 other active

1 trial
Study to Evaluate Adverse Events, Change in Disease Activity, and How Oral ABBV-101 Moves Through the Body in Adult Participants With B-Cell Malignancies

AbbVie Deutschland GmbH & Co. KG

Select B-Cell malignancies.

phase 1 other active

1 trial
Study to Evaluate the PK and Safety of Oral Decitabine and Cedazuridine in Cancer Patients with Hepatic Impairment

Taiho Pharma Netherlands B.V.

Solid tumor, Acute myeloid lymphoma (AML), Myelodysplastic syndrome (MDS)

phase 1 other active

1 trial
Study to Evaluate the PK and Safety of Oral Decitabine and Cedazuridine in Cancer Patients with Renal Impairment

Taiho Pharma Netherlands B.V.

Acute myeloid lymphoma (AML), myelodysplastic syndrome (MDS), or solid tumors

phase 1 other active

1 trial
Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of ION464 Administered to Adults With Multiple System Atrophy (HORIZON)

IONIS PHARMACEUTICALS INC

Multiple System Atrophy

phase 1 other active

1 trial
Study to Investigate the Safety and Tolerability of Odronextamab in Patients With CD20+ B-Cell Malignancies

Lacuna Pharma Pty Ltd

B-cell non-Hodgkin lymphoma (NHL)

phase 1 other active

1 trial
Study to assess the safety and tolerability of CMR316 in healthy volunteers and patients with Idiopathic Pulmonary Fibrosis.

The George Institute

Idiopathic Pulmonary Fibrosis

phase 1 other active

1 trial
Study to assess the safety, pharmacokinetics and efficacy of HMPL-523 in patients with Immune Thrombocytopenia

Hutchmed Europe B.V.

Primary immune thrombocytopenia (ITP)

phase 1 other active

1 trial
Study to evaluate the addition of an experimental drug, CC-90010, to the usual treatment of brain cancer after surgery

Celgene Europe Limited

Subjects with newly diagnosed WHO Grade IV glioblastoma (ndGBM) who have undergone complete or partial tumor resection

phase 1 other active

1 trial
Study to evaluate the pharmacokinetics, safety and tolerability of Secukinumab in patients with GCA or PMR

Novartis Pharmaceuticals

Polymyalgia rheumatica (PMR), Giant cell arteritis (GCA)

phase 1 other active

1 trial
Study to evaluate the safety, tolerability, maximum tolerated dose and clinical activity of TNB-383B when given to patients with multiple myeloma

AbbVie Deutschland GmbH & Co. KG

Relapsed or refractory multiple myeloma

phase 1 other active

1 trial
Study which tests 3 medicines (SB27, EU sourced Keytruda, and US sourced Keytruda) in early or locally advanced non-small cell lung cancer patients who underwent surgery and adjuvant chemotherapy

Samsung Bioepis NL B.V.

Non-small cell lung cancer

phase 1 other active

1 trial
Subconjunctival aflibercept

Regeneron UK Limited

Corneal Neovascularization

phase 1 small molecule terminated

1 trial
Subcutaneous Tarlatamab in Subjects with Extensive Stage Small Cell Lung Cancer (DeLLphi-308)

Amgen

Extensive Stage Small Cell Lung Cancer (DeLLphi-308)

phase 1 other active

1 trial
Subcutaneous Trastuzumab Deruxtecan Phase 1 Trial.

Daiichi Sankyo

Advanced Solid Tumor

phase 1 other active

1 trial
Sublingual Tizanidine HCl

Teva Pharma GmbH

Traumatic Brain Injury

phase 1 small molecule completed

1 trial
Sublingual film containing BXCL501 (Dexmedetomidine)

BioXcel Therapeutics

Agitation

phase 1 small molecule completed

1 trial
Suboxone

BRIGHT MINDS BIOSCIENCES INC.

Cocaine-related Disorders

phase 1 small molecule completed

1 trial
Sugar Pill

BRIGHT MINDS BIOSCIENCES INC.

Substance-Related Disorders

phase 1 small molecule completed

1 trial
Sulfasalazine

Lakefront Biotherapeutics NV

Healthy

phase 1 small molecule completed

1 trial
Sulopenem

Iterum Therapeutics plc

Urinary Tract Infections

phase 1 small molecule terminated

1 trial
Sumatriptan succinate

Teva Pharma GmbH

Migraine Disorders

phase 1 small molecule completed

1 trial
Sumatriptan succinate

Teva Pharma GmbH

Healthy

phase 1 small molecule completed

3 trials
Sunitinib, Pemetrexed

Pfizer

Neoplasm, Malignant

phase 1 small molecule completed

1 trial
Sup19 CAR-T

Xiyuan Hospital of China Academy of Chinese Medical Sciences

B-Acute Lymphoblastic Leukemia

phase 1 mab active

1 trial
Sutezolid

BRIGHT MINDS BIOSCIENCES INC.

Tuberculosis

phase 1 small molecule completed

1 trial
Switch active lifestyles brought to you by MediaWise

Lxo Ireland Designated Activity Company

Overweight

phase 1 other completed

1 trial
T cell injection targeting CD7 chimeric antigen receptor

The First People's Hospital of Lianyungang

T Lymphoblastic Leukemia/Lymphoma

phase 1 mab active

1 trial
T cell injection targeting CD7 chimeric antigen receptor

The First People's Hospital of Lianyungang

CD7-positive Relapsed/Refractory Lymphoid Hematologic Malignancies

phase 1 mab active

1 trial
T3011

Xiyuan Hospital of China Academy of Chinese Medical Sciences

Malignant Ascites

phase 1 small molecule active

1 trial
TAEST16001

Chongqing Precision Biotech Co., Ltd

Liver Cancer Stage IV

phase 1 small molecule completed

1 trial
TAEST16001 cells

Chongqing Precision Biotech Co., Ltd

Soft Tissue Sarcoma

phase 1 mab active

1 trial
TAF/EVG Vaginal Insert

United Therapeutics Europe Ltd

Hiv

phase 1 small molecule completed

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

Quick answer

Top sponsors

Study of EGF816 in combination with selected targeted agents in EGFR-mutant NSCLC.

Study of GS-0151 in Participants With Rheumatoid Arthritis

Study of GS-5319 in Adults With Solid Tumors

Study of JNJ-74856665 in patients with Acute Myeloid Leukemia or Myelodysplastic Syndrome

Study of MK-4830 as Monotherapy and in Combination With Pembrolizumab (MK-3475) in Participants With Advanced Solid Tumors (MK-4830-001)

Study of PIT565 in relapsed and/or refractory B-cell malignancies

Study of REGN6569 and Cemiplimab in Adult Patients with Advanced Solid Tumor Malignancies

Study of Repotrectinib and CYP450 probe Cocktail in Patients with locally advanced or Metastatic Tyrosine Kinase Inhibitors (TKI)-Pretreated ROS1-Positive Non-small Cell Lung Cancer (NSCLC)

Study of Safety, Tolerability, Pharmacodynamics and Pharmacokinetics of NIO752 in Early Alzheimer's Disease Participants

Study of TSR-022, a Monoclonal Antibody, in Patients with Advanced Solid Tumors

Study of U3-1402 in subjects with non-small cell lung cancer

Study of diclofenac skin reservoir formation and emptying after Voltaren Emulgel 2.32% application in healthy participants

Study of safety and antitumor activity of GEN1056 in participants with advanced solid tumors

Study of safety and efficacy of DKY709 alone or in combination with PDR001 in patients with advanced solid tumors.

Study of safety and preliminary efficacy of VAY736 given alone or in combination with other antineoplastic agents in patients with NHL

Study to Evaluate Adverse Events, Change in Disease Activity, and How Intravenously Infused ABBV-291 Moves Through the Body in Adult Participants With Non-Hodgkin's Lymphoma

Study to Evaluate Adverse Events, Change in Disease Activity, and How Oral ABBV-101 Moves Through the Body in Adult Participants With B-Cell Malignancies

Study to Evaluate the PK and Safety of Oral Decitabine and Cedazuridine in Cancer Patients with Hepatic Impairment

Study to Evaluate the PK and Safety of Oral Decitabine and Cedazuridine in Cancer Patients with Renal Impairment

Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of ION464 Administered to Adults With Multiple System Atrophy (HORIZON)

Study to Investigate the Safety and Tolerability of Odronextamab in Patients With CD20+ B-Cell Malignancies

Study to assess the safety and tolerability of CMR316 in healthy volunteers and patients with Idiopathic Pulmonary Fibrosis.

Study to assess the safety, pharmacokinetics and efficacy of HMPL-523 in patients with Immune Thrombocytopenia

Study to evaluate the addition of an experimental drug, CC-90010, to the usual treatment of brain cancer after surgery

Study to evaluate the pharmacokinetics, safety and tolerability of Secukinumab in patients with GCA or PMR

Study to evaluate the safety, tolerability, maximum tolerated dose and clinical activity of TNB-383B when given to patients with multiple myeloma

Study which tests 3 medicines (SB27, EU sourced Keytruda, and US sourced Keytruda) in early or locally advanced non-small cell lung cancer patients who underwent surgery and adjuvant chemotherapy

Subconjunctival aflibercept

Subcutaneous Tarlatamab in Subjects with Extensive Stage Small Cell Lung Cancer (DeLLphi-308)

Subcutaneous Trastuzumab Deruxtecan Phase 1 Trial.

Sublingual Tizanidine HCl

Sublingual film containing BXCL501 (Dexmedetomidine)

Suboxone

Sugar Pill

Sulfasalazine

Sulopenem

Sumatriptan succinate

Sumatriptan succinate

Sunitinib, Pemetrexed

Sup19 CAR-T

Sutezolid

Switch active lifestyles brought to you by MediaWise

T cell injection targeting CD7 chimeric antigen receptor

T cell injection targeting CD7 chimeric antigen receptor

T3011

TAEST16001

TAEST16001 cells

TAF/EVG Vaginal Insert

Frequently asked questions

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