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

Phase 1 trial of valemetostat and darolutamide in mCRPC

Daiichi Sankyo

Metastatic Castration Resistant Prostate Cancer (mCRPC)

phase 1 other active

1 trial
Phase 1, Open-Label, single arm (Non-comparator) Study to Evaluate the Pharmacokinetics and Safety of a Single Dose of Oral Gepotidacin in Addition to Antibacterial Standard of Care in Pediatric Participants from 2 to less than 12 years of age with a Suspected or Confirmed Bacterial Infection or Receiving Prophylaxis with Antibiotics

GlaxoSmithKline

Urinary Tract Infections

phase 1 other active

1 trial
Phase 1, Randomized, Double-blind, Placebo-Controlled, First-in-Human Single Ascending Dose Study in Healthy Participants to Assess the Safety, Tolerability, and Pharmacokinetics of JNJ-95597528 and a Proof of Mechanism Study in Participants with Mild to Moderate Asthma

Janssen-Cilag International N.V.

Mild to Moderate Asthma

phase 1 other active

1 trial
Phase 1/1b, Multicenter, Open-Label, Dose Escalation and Dose Expansion Study of RMC-6291 Monotherapy in Subjects with Advanced KRASG12C Mutant Solid Tumors.

Revolution Medicines

Non-Small Cell Lung Cancer (NSCLC), Pancreatic Ductal Adenocarcinoma, Advanced Solid Tumor, Colorectal Cancer (CRC)

phase 1 other active

1 trial
Phase 1/2 Study of Erdafitinib Intravesical Delivery System (TAR-210) in Participants with Non-Muscle-Invasive or Muscle-Invasive Bladder Cancer

Janssen-Cilag International N.V.

Localized Bladder Cancer

phase 1 other active

1 trial
Phase 1: Web-based intervention (MyWebQuit) with 1-way text messages

BRIGHT MINDS BIOSCIENCES INC.

Social Anxiety Disorder

phase 1 other terminated

1 trial
Phase 1b Study of Dato-DXd in Combination with Pembrolizumab with or without Platinum Chemotherapy in Advanced or Metastatic Non-Small Cell Lung Cancer

Daiichi Sankyo

Non-small cell lung cancer

phase 1 other active

1 trial
Phase 1b Study of Tarlatamab + ZL-1310 +/- Anti-PD-L1 in Small Cell Lung Cancer

Amgen

Small Cell Lung Cancer

phase 1 other active

1 trial
Phase 1b Study of Tarlatamab in Combination with YL201 with or without Anti-PD-L1 in Subjects with Extensive Stage Small Cell Lung Cancer (DeLLphi-310)

Amgen

Extensive Stage Small Cell Lung Cancer (ES-SCLC)

phase 1 other active

1 trial
Phase 1b safety study of xevinapant, weekly cisplatin, and radiotherapy in participants with unresected LA SCCHN

Merck Sharp and Dohme

Locally Advanced Squamous Cell Carcinoma of the Head and Neck

phase 1 other active

1 trial
Phase I Clinical Study to Assess Safety and Efficacy of Repotrectinib Combined with Osimertinib in Patients with Advanced, Metastatic EGFR Mutant NSCLC (TOTEM).

The George Institute

Non-small cell lung cancer (NSCLC)

phase 1 other active

1 trial
Phase I Study of PM54 Administered to Patients with Advanced Solid Tumors

Lacuna Pharma Pty Ltd

Selected Advanced Solid Tumors

phase 1 other active

1 trial
Phase I Study of Plitidepsin Administered Intravenously as a Single Dose in Healthy Volunteers

Lacuna Pharma Pty Ltd

Virus diseases

phase 1 other active

1 trial
Phase I clinical trial evaluating the safety, tolerability, and absorption of a topical product containing latanoprost acid in healthy participants.

Lacuna Pharma Pty Ltd

Androgenetic alopecia

phase 1 other active

1 trial
Phase I open-label, multi-center study to evaluate the safety, tolerability, dosimetry, and preliminary activity of [177Lu]Lu-NNS309 in patients with pancreatic, lung, breast and colorectal cancers.

Novartis Pharmaceuticals

Locally advanced or metastatic unresectable colorectal cancer (CRC), Locally advanced unresectable or metastatic breast cancer (BC), Locally advanced unresectable or metastatic non-small cell lung cancer (NSCLC), Locally advanced unresectable or metastatic pancreatic ductal adenocarcinoma (PDAC)

phase 1 other active

1 trial
Phase I single-blind clinical trial to evaluate the safety and local immune activation of a toll-like receptor 5 agonist (FLAMOD) administered by aerosol

The George Institute

Pneumonia

phase 1 other active

1 trial
Phase I study of 225Ac-PSMA I&T in prostate cancer

Disc Medicine

metastatic prostate cancer

phase 1 other active

1 trial
Phase I study of IAG933 in patients with advanced Mesothelioma and other solid tumors

Novartis Pharmaceuticals

Advanced mesothelioma or other solid tumors harboring certain molecular alterations in the Hippo pathway

phase 1 other active

1 trial
Phase I study of MGY825 in patients with lung cancer

Novartis Pharmaceuticals

Advanced non-small cell lung cancer with or without NFE2L2/KEAP1/CUL3 mutations in adult patients

phase 1 other active

1 trial
Phase I, Open-Label Study to Evaluate the Pharmacokinetics, Safety and Tolerability of BIA 28-6156 in Participants with Varying Degrees of Renal Impairment

Bial Portela & Companhia S.A.

Parkinson's disease

phase 1 other active

1 trial
Phase I, single and multiple ascending dose, randomized, double-blind, placebo-controlled, parallel-group clinical trial to evaluate the safety, tolerability and pharmacokinetics of topical ocular administration of DS101 in healthy subjects.

The George Institute

Diabetic retinopathy.

phase 1 other active

1 trial
Phase I, single and multiple ascending dose, randomized, double-blind, placebo-controlled, parallel-group clinical trial to evaluate the safety, tolerability and pharmacokinetics of topical ocular administration of DS101 in healthy subjects.

The George Institute

Diabetic retinopathy.

phase 1 other active

1 trial
Phase I-Ib clinical trial of safety and immunobiology of prophylactic infusion of lymphocytes and NK cells after Allo-HCT.

The George Institute

graft-versus-host disease

phase 1 other active

1 trial
Phase I-Ib clinical trial of safety and immunobiology of prophylactic infusion of lymphocytes and NK cells after Allo-HCT.

The George Institute

graft-versus-host disease

phase 1 other active

1 trial
Phase IB Study to Assess the Safety, Tolerability and Efficacy of PM14 in combination with Atezolizumab in Pretreated Patients with Selected Advanced Solid Tumors

Lacuna Pharma Pty Ltd

Advanced solid tumors

phase 1 other active

1 trial
Phase IB open label, long-term, extension basket trial of RAY121 to inhibit classical complement pathway in immunological diseases (RAINBOW-LTE trial)

Lacuna Pharma Pty Ltd

Immune-mediated necrotizing myopathy, Antiphospholipid syndrome, Behçet’s Syndrome, Bullous pemphigoid, Dermatomyositis, Immune Thrombocytopenia

phase 1 other active

1 trial
Phase Ib Dose Finding Study of [177Lu]Lu-NeoB in Combination with RT and TMZ in Newly Diagnosed Glioblastoma and as a Single Agent in Recurrent Glioblastoma

Novartis Pharmaceuticals

Glioblastoma

phase 1 other active

1 trial
Phase Ib Dose-Ranging Study of the Safety, PK, PD & Efficacy of the Activin Signaling Inhibitor HS235 vs placebo added to background therapy in PAH (SEASIDE)

Lacuna Pharma Pty Ltd

Pulmonary arterial hypertension

phase 1 other active

1 trial
Phase Ib Open Label Basket Trial of RAY121 to Inhibit Classical Complement Pathway in Immunological Diseases (RAINBOW Trial)

Lacuna Pharma Pty Ltd

Bullous pemphigoid, Behçet’s Syndrome, Dermatomyositis, Antiphospholipid syndrome, Immune-mediated necrotizing myopathy, Immune Thrombocytopenia

phase 1 other active

1 trial
Phase Ib Randomised, Placebo-controlled, Double-blind, Multicentre Study to Assess the Effects and Safety of AZD5462 on top of Dapagliflozin in Participants with Heart Failure and Moderate Renal Impairment

AstraZeneca AB

Moderate Renal Impairment, Heart Failure

phase 1 other active

1 trial
Phase Ib Safety, Tolerability and Pharmacokinetic Study of Subcutaneously Administered HER-096 in Healthy Volunteer Subjects and Patients with Parkinson’s Disease

Lacuna Pharma Pty Ltd

Parkinson’s Disease

phase 1 other active

1 trial
Phase Ib of Cyclophosphamide, Pomalidomide, Dexamethasone and Daratumumab (CPD-DARA) in patients with relapsed/refractory multiple myeloma. (The CPD-DARA Study).

Ningbo Cancer Hospital

Relapsed/ refractory multiple myeloma

phase 1 other active

1 trial
Phenytoin

BRIGHT MINDS BIOSCIENCES INC.

Cocaine-Related Disorders

phase 1 small molecule completed

1 trial
Physical Activity Educational Materials

United Therapeutics Europe Ltd

Physical Inactivity

phase 1 other completed

1 trial
Pilot Study on Subcutaneously Administered Immunotherapy for the Treatment of Cervical Cancer

Disc Medicine

Cervical Cancer

phase 1 other active

1 trial
Pimavanserin

Acadia Pharmaceuticals B.V.

Parkinson Disease

phase 1 small molecule terminated

1 trial
Pioglitazone

Takeda

Healthy

phase 1 small molecule completed

1 trial
Piracetam

BRIGHT MINDS BIOSCIENCES INC.

Cocaine-Related Disorders

phase 1 small molecule terminated

2 trials
Pirfenidone

Lakefront Biotherapeutics NV

Healthy

phase 1 small molecule completed

1 trial
Pitavastatin

United Therapeutics Europe Ltd

Acute Myeloid Leukemia

phase 1 small molecule completed

1 trial
Placebo

BRIGHT MINDS BIOSCIENCES INC.

Cocaine Addiction

phase 1 small molecule completed

1 trial
Placebo

BRIGHT MINDS BIOSCIENCES INC.

Cannabis Use

phase 1 small molecule active

1 trial
Placebo

Rhythm Pharmaceuticals Netherlands B.V.

Obesity

phase 1 small molecule completed

1 trial
Placebo

BRIGHT MINDS BIOSCIENCES INC.

Methamphetamine Abuse

phase 1 small molecule completed

1 trial
Placebo

BRIGHT MINDS BIOSCIENCES INC.

D-limonene and THC Pharmacodynamics

phase 1 small molecule completed

1 trial
Placebo

IONIS PHARMACEUTICALS INC

Healthy Volunteers

phase 1 small molecule completed

1 trial
Placebo

Pfizer

Respiratory Syncytial Virus Infections

phase 1 small molecule terminated

1 trial
Placebo

KYOWA KIRIN AUSTRALIA PTY LTD

Healthy Volunteers Essential Hypertension

phase 1 small molecule 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

Quick answer

Top sponsors

Phase 1 trial of valemetostat and darolutamide in mCRPC

Phase 1, Randomized, Double-blind, Placebo-Controlled, First-in-Human Single Ascending Dose Study in Healthy Participants to Assess the Safety, Tolerability, and Pharmacokinetics of JNJ-95597528 and a Proof of Mechanism Study in Participants with Mild to Moderate Asthma

Phase 1/1b, Multicenter, Open-Label, Dose Escalation and Dose Expansion Study of RMC-6291 Monotherapy in Subjects with Advanced KRASG12C Mutant Solid Tumors.

Phase 1/2 Study of Erdafitinib Intravesical Delivery System (TAR-210) in Participants with Non-Muscle-Invasive or Muscle-Invasive Bladder Cancer

Phase 1: Web-based intervention (MyWebQuit) with 1-way text messages

Phase 1b Study of Dato-DXd in Combination with Pembrolizumab with or without Platinum Chemotherapy in Advanced or Metastatic Non-Small Cell Lung Cancer

Phase 1b Study of Tarlatamab + ZL-1310 +/- Anti-PD-L1 in Small Cell Lung Cancer

Phase 1b Study of Tarlatamab in Combination with YL201 with or without Anti-PD-L1 in Subjects with Extensive Stage Small Cell Lung Cancer (DeLLphi-310)

Phase 1b safety study of xevinapant, weekly cisplatin, and radiotherapy in participants with unresected LA SCCHN

Phase I Clinical Study to Assess Safety and Efficacy of Repotrectinib Combined with Osimertinib in Patients with Advanced, Metastatic EGFR Mutant NSCLC (TOTEM).

Phase I Study of PM54 Administered to Patients with Advanced Solid Tumors

Phase I Study of Plitidepsin Administered Intravenously as a Single Dose in Healthy Volunteers

Phase I clinical trial evaluating the safety, tolerability, and absorption of a topical product containing latanoprost acid in healthy participants.

Phase I open-label, multi-center study to evaluate the safety, tolerability, dosimetry, and preliminary activity of [177Lu]Lu-NNS309 in patients with pancreatic, lung, breast and colorectal cancers.

Phase I single-blind clinical trial to evaluate the safety and local immune activation of a toll-like receptor 5 agonist (FLAMOD) administered by aerosol

Phase I study of 225Ac-PSMA I&T in prostate cancer

Phase I study of IAG933 in patients with advanced Mesothelioma and other solid tumors

Phase I study of MGY825 in patients with lung cancer

Phase I, Open-Label Study to Evaluate the Pharmacokinetics, Safety and Tolerability of BIA 28-6156 in Participants with Varying Degrees of Renal Impairment

Phase I, single and multiple ascending dose, randomized, double-blind, placebo-controlled, parallel-group clinical trial to evaluate the safety, tolerability and pharmacokinetics of topical ocular administration of DS101 in healthy subjects.

Phase I, single and multiple ascending dose, randomized, double-blind, placebo-controlled, parallel-group clinical trial to evaluate the safety, tolerability and pharmacokinetics of topical ocular administration of DS101 in healthy subjects.

Phase I-Ib clinical trial of safety and immunobiology of prophylactic infusion of lymphocytes and NK cells after Allo-HCT.

Phase I-Ib clinical trial of safety and immunobiology of prophylactic infusion of lymphocytes and NK cells after Allo-HCT.

Phase IB Study to Assess the Safety, Tolerability and Efficacy of PM14 in combination with Atezolizumab in Pretreated Patients with Selected Advanced Solid Tumors

Phase IB open label, long-term, extension basket trial of RAY121 to inhibit classical complement pathway in immunological diseases (RAINBOW-LTE trial)

Phase Ib Dose Finding Study of [177Lu]Lu-NeoB in Combination with RT and TMZ in Newly Diagnosed Glioblastoma and as a Single Agent in Recurrent Glioblastoma

Phase Ib Dose-Ranging Study of the Safety, PK, PD & Efficacy of the Activin Signaling Inhibitor HS235 vs placebo added to background therapy in PAH (SEASIDE)

Phase Ib Open Label Basket Trial of RAY121 to Inhibit Classical Complement Pathway in Immunological Diseases (RAINBOW Trial)

Phase Ib Randomised, Placebo-controlled, Double-blind, Multicentre Study to Assess the Effects and Safety of AZD5462 on top of Dapagliflozin in Participants with Heart Failure and Moderate Renal Impairment

Phase Ib Safety, Tolerability and Pharmacokinetic Study of Subcutaneously Administered HER-096 in Healthy Volunteer Subjects and Patients with Parkinson’s Disease

Phase Ib of Cyclophosphamide, Pomalidomide, Dexamethasone and Daratumumab (CPD-DARA) in patients with relapsed/refractory multiple myeloma. (The CPD-DARA Study).

Phenytoin

Physical Activity Educational Materials

Pilot Study on Subcutaneously Administered Immunotherapy for the Treatment of Cervical Cancer

Pimavanserin

Pioglitazone

Piracetam

Pirfenidone

Pitavastatin

Placebo

Placebo

Placebo

Placebo

Placebo

Placebo

Placebo

Placebo

Frequently asked questions

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