Merck & Co. is deeply committed to advancing healthcare through innovative research and development of medicines and vaccines. The company has a robust pipeline that includes over 60 programs in Phase 2 and more than 30 in Phase 3 clinical trials, focusing on various therapeutic areas such as oncology, immunology, and infectious diseases. Their research emphasizes the importance of collaboration, as evidenced by partnerships with other pharmaceutical companies to develop cutting-edge treatments, including antibody-drug conjugates and small molecules targeting specific diseases. Notable investigational products include MK-3000, a tri-specific antibody for diabetic macular edema, and MK-1084, a selective KRAS G12C inhibitor for non-small cell lung cancer.

In addition to their extensive pipeline, Merck is dedicated to sustainability and responsible operations, aiming to create a healthier future for communities worldwide. The company actively engages in clinical trials, which are crucial for discovering new treatments that can save and improve lives. Their commitment to diversity in clinical trials is highlighted through initiatives like the Patients Podcast, which fosters open discussions about the importance of representation in medical research. Overall, Merck & Co. continues to leverage scientific advancements to address pressing health challenges globally.

United States

Merck & Co., Inc. operates as a healthcare company worldwide. It operates through two segments, Pharmaceutical and Animal Health. The Pharmaceutical segment offers human health pharmaceutical products in the areas of oncology, hospital acute care, immunology, neuroscience, virology, cardiovascular, and diabetes, as well as vaccine products, such as preventive pediatric, adolescent, and adult vaccines. The Animal Health segment discovers, develops, manufactures, and markets veterinary pharmaceuticals, vaccines, and health management solutions and services, as well as digitally connected identification, traceability, and monitoring products. It serves drug wholesalers and retailers, hospitals, and government agencies; managed health care providers, such as health maintenance organizations, pharmacy benefit managers, and other institutions; and physicians and physician distributors, veterinarians, and animal producers. The company has collaborations with AstraZeneca PLC; Bayer AG; Eisai Co., Ltd.; Ridgeback Biotherapeutics; and Gilead Sciences, Inc. to jointly develop and commercialize long-acting treatments in HIV. Merck & Co., Inc. was founded in 1891 and is headquartered in Kenilworth, New Jersey.

Cancer

Cardiovascular Diseases

Central Nervous System (CNS)

Digestive System Diseases

Hematologic Diseases

Immune System Diseases

Infectious Diseases

Kidney Diseases

Lung Diseases

Metabolic Diseases

Nervous System Diseases

Various

Merck & Co

Non-small cell lung carcinoma

Solid tumor/s

KEYTRUDA is an anti-programmed death receptor-1 (PD-1) therapy that &nbsp;works by increasing the ability of the body’s immune system to help &nbsp;detect and fight tumor cells. KEYTRUDA is a humanized monoclonal &nbsp;antibody that blocks the interaction between PD-1 and its ligands, PD-L1 &nbsp;and PD-L2, thereby activating T lymphocytes which may affect both tumor &nbsp;cells and healthy cells.

KEYTRUDA

Colorectal cancer

Metastatic colorectal cancer

TUKYSA is an oral medicine that is a tyrosine kinase inhibitor of the &nbsp;HER2 protein. In vitro (in lab studies), TUKYSA inhibited &nbsp;phosphorylation of HER2 and HER3, resulting in inhibition of downstream &nbsp;MAPK and AKT signaling and cell growth (proliferation), and showed &nbsp;anti-tumor activity in HER2-expressing tumor cells. In vivo (in living &nbsp;organisms), TUKYSA inhibited the growth of HER2-expressing tumors. The &nbsp;combination of TUKYSA and the anti-HER2 antibody trastuzumab showed &nbsp;increased anti-tumor activity in vitro and in vivo compared to either &nbsp;medicine alone.

TUKYSA (Tucatinib)

Urothelial cancer

PADCEV® (enfortumab vedotin-ejfv) + KEYTRUDA® (pembrolizumab) 

Carcinoma

Endometrial cancer

KEYTRUDA +carboplatin + paclitaxel

Cytomegalovirus

Viral infection

PREVYMIS™ (letermovir) 

Pulmonary arterial hypertension

Sotatercept is an investigational, potential first-in-class activin signaling inhibitor biologic being studied for the treatment of PAH (WHO Group 1). PAH is a rare disease caused by hyperproliferation of cells in the arterial walls in the lung, leading to narrowing and abnormal constriction. In pre-clinical models, sotatercept has been shown to modulate vascular cell proliferation, reversing vascular and right ventricle remodeling.

WINREVAIR (sotatercept-csrk)

KEYTRUDA in comb w/chemotherapy

Vaccine

ProQuad® is a vaccine indicated for active immunization for the prevention of measles, mumps, rubella, and varicella in children 12 months through 12 years of age. It was approved by the FDA in 2005. VARIVAX® is a vaccine indicated for active immunization for the prevention of varicella in individuals 12 months of age or older. It received FDA approval in 1995 and remains the only varicella vaccine available for use in the U.S. M-M-R®II is indicated for active immunization for the prevention of measles, mumps, and rubella in individuals 12 months of age or older and received FDA approval in 1978.

M-M-R®II, VARIVAX®, and ProQuad®

Malignant pleural/peritoneal mesothelioma

Mesothelioma

KEYTRUDA+ chemotherapy

Gastric cancer

Gastroesophageal adenocarcinomas

KEYTRUDA + chemotherapy 

Biliary Tract Cancer

KEYTRUDA+ chemotherapy 

Castration-resistant prostate cancer

LYNPARZA(olaparib) + abi/pred

KEYTRUDA+ trastuzumab+ chemotherapy  

Cervical cancer

KEYTRUDA is an anti-programmed death receptor-1 (PD-1) therapy that works by increasing the ability of the body’s immune system to help detect and fight tumor cells. KEYTRUDA is a humanized monoclonal antibody that blocks the interaction between PD-1 and its ligands, PD- L1 and PD-L2, thereby activating T lymphocytes which may affect both tumor cells and healthy cells.

KEYTRUDA in comb w/ EBRT + brachytherapy

Pneumococcal Conjugate Vaccine

V116 is an investigational, 21-valent pneumococcal conjugate vaccine in Phase 3 development for the prevention of invasive pneumococcal disease and pneumococcal pneumonia in the adult population. V116 is specifically designed to address the serotypes that represent adult pneumococcal disease, including eight unique serotypes, 15A, 15C, 16F, 23A, 23B, 24F, 31 and 35B, which account for approximately 30% of adult disease, according to 2019 pre-pandemic CDC data. V116 has potential to expand disease coverage to help protect against invasive pneumococcal disease in more than 85% of individuals 65 and older, based on the same data.

 CAPVAXIVE (V116)

Ebola

ive recombinant viral vaccine consisting of a vesicular stomatitis virus (VSV) backbone deleted for the VSV envelope glycoprotein and substituted with the envelope glycoprotein of the Zaire ebolavirus (Kikwit 1995 strain).

ERVEBO

Human papillomavirus

Human Papillomavirus 9-valent Vaccine

GARDASIL 9

Urothelial carcinoma

KEYTRUDA+ Padcev (enfortumab vedotin)

Hemangioblastoma

Pancreatic neuroendocrine tumors

Renal cell carcinoma

von Hippel-Lindau

WELIREG (belzutifan) is indicated for the treatment of adult patients with von Hippel-Lindau (VHL) disease who require therapy for associated renal cell carcinoma (RCC), central nervous system (CNS) hemangioblastomas, or pancreatic neuroendocrine tumors (pNET), not requiring immediate surgery.

WELIREG® (belzutifan)

Paraganglioma

Pheochromocytoma

 KEYTRUDA (pembrolizumab) injection

Respiratory syncytial virus

Clesrovimab (MK-1654) is an investigational, extended half-life monoclonal antibody (mAb) developed as a passive immunization for the prevention of RSV. Clesrovimab is designed to be administered as the same single dose, regardless of birth weight, and is being studied in healthy pre-term, full-term and at-risk infants to provide direct, rapid and durable protection through their first RSV season against mild, moderate and severe RSV.

Clesrovimab (MK-1654)

Head and neck squamous cell carcinoma

KEYTRUDA® (pembrolizumab)

KEYTRUDA + Berahyaluronidase Alfa

Human immunodeficiency virus

Islatravir+ Doravirine

Chronic cough

Gefapixant (MK-7264)

Crohns disease

Irritable bowel syndrome

Ulcerative colitis

PRA023 is an IgG1 humanized mAb that has been shown to block TL1A. &nbsp;Third-party antibody programs against TL1A have been shown to reduce &nbsp;both intestinal inflammation and fibrosis in preclinical studies, and &nbsp;this target has been clinically-validated in a third-party Phase 2a &nbsp;clinical trial in UC. PRA023 binds both soluble and membrane-associated &nbsp;human TL1A with high affinity and specificity and has the potential to &nbsp;substantially improve outcomes for moderate-to-severe IBD patients &nbsp;predisposed to increased TL1A. Prometheus is developing PRA023 for the &nbsp;two most common forms of IBD, ulcerative colitis (UC) and Crohn's &nbsp;disease (CD).
<a href="https://prometheusbiosciences.investorroom.com/2021-03-03-Prometheus-Biosciences-Commences-Dosing-in-Multiple-Ascending-Dose-MAD-Portion-of-Ongoing-Phase-1a-Clinical-Study-of-PRA023">Source</a>

Tulisokibart (MK-7240) (PRA023) (Anti-TL1A mAb) 

Thrombocythemia

We are developing our internally discovered lead product candidate, &nbsp;bomedemstat, for the treatment of myeloproliferative neoplasms (MPNs), a &nbsp;family of related, chronic cancers of the bone marrow. Bomedemstat is &nbsp;an orally available, small molecule, inhibitor of LSD1. Currently, &nbsp;bomedemstat is being tested in clinical studies as a potentially &nbsp;disease-modifying monotherapy for essential thrombocythemia (ET), &nbsp;myelofibrosis (MF), and polycythemia vera (PV).

Bomedemstat

Tulisokibart (PRA023) (Anti-TL1A mAb)

COVID-19

LAGEVRIO, a nucleoside analogue that inhibits SARS-CoV-2 replication by viral mutagenesis, for the treatment of adults with a current diagnosis of mild-to-moderate coronavirus disease 2019 (COVID-19) who are at high risk for progression to severe COVID-19, including hospitalization or death, and for whom alternative COVID-19 treatment options approved or authorized by FDA are not accessible or clinically appropriate. LAGEVRIO is not FDA-approved for any use, including the treatment of COVID-19.

LAGEVRIO™ (molnupiravir)

Hypercholesterolemia

MK-0616 is an investigational, potentially first oral PCSK9 inhibitor designed to lower low density lipoprotein (LDL) cholesterol. MK-0616 is a macrocyclic peptide that binds to PCSK9 and inhibits the interaction of PCSK9 with LDL receptors. This results in greater numbers of LDL receptors available on the cell surface to remove LDL cholesterol from the blood.

MK-0616

KEYTRUDA+pemetrexed

KEYTRUDA is an anti-programmed death receptor-1 (PD-1) therapy that works by increasing the ability of the body’s immune system to help detect and fight tumor cells. KEYTRUDA is a humanized monoclonal antibody that blocks the interaction between PD-1 and its ligands, PD-L1 and PD-L2, thereby activating T lymphocytes which may affect both tumor cells and healthy cells.

KEYTRUDA + LENVIMA

ER+/HER2- breast cancer

Cardiovascular disease

MK-0616 is an investigational, potentially first oral PCSK9 inhibitor designed to lower LDL cholesterol via the same biological mechanism as currently approved injectable PCSK9 inhibitors but in a daily pill form. MK-0616 is a macrocyclic peptide that binds to PCSK9 and inhibits the interaction of PCSK9 with LDL receptors.

KEYTRUDA +LENVIMA® (lenvatinib)

KEYTRUDA 

Patritumab deruxtecan (HER3-DXd)

Chronic lymphocytic leukemia

Small lymphocytic lymphoma

Nemtabrutinib is an investigational oral, reversible, non-covalent BTK inhibitor that suppresses oncogenic B-cell receptor signaling with activity against wild-type BTK and BTK pathway mutants. Nemtabrutinib aims to address a common mechanism of resistance with currently available irreversible, covalent BTK inhibitors by binding in an alternative way to the BTK protein.

Nemtabrutinib

MK-2870 is an investigational ADC that consists of an antibody targeting TROP2 linked to a belotecan-derived payload. TROP2 is highly expressed in a variety of epithelial-derived tumors and can promote tumor cell proliferation, invasion and metastasis. TROP2 ADCs specifically target TROP2-expressing tumor cells to deliver cytotoxic effects and have shown encouraging anti-tumor activity in clinical studies.

MK-2870

MK-5684 is an oral, non-steroidal and selective inhibitor of the CYP11A1 enzyme discovered and developed by Orion and is being investigated for the treatment of hormone-dependent cancers, such as prostate cancer. By inhibiting CYP11A1 enzyme activity, MK-5684 is designed to suppress the production of all steroid hormones and their precursors that may activate the androgen receptor signaling pathway.

MK-5684 (ODM-208)

KEYTRUDA® (pembrolizumab)+ LYNPARZA® (olaparib) 

MK-1084 is an investigational, potent and specific KRAS G12C covalent inhibitor. Mutations in KRAS are among the most prevalent mutations found in cancer, occurring with high frequency in non-small cell lung cancer, pancreatic, urogenital and colorectal cancers. The KRAS G12C mutation is the most frequently observed KRAS mutation in patients, occurring in approximately 14% of non-small cell lung cancers (adenocarcinoma). Despite decades of research and recognition of the therapeutic importance of targeting KRAS, the development of small molecule inhibitors targeting KRAS mutations has been challenging.

MK-1084 +KEYTRUDA®

Breast cancer

Triple-negative breast cancer

Small cell lung cancer

Ifinatamab Deruxtecan (I-DXd)

Thrombocytopenia

Hepatocellular carcinoma

KEYTRUDA + LENVIMA  in comb w/TACE

KEYTRUDA is an anti-programmed death receptor-1 (PD-1) therapy that works by increasing the ability of the body’s immune system to help detect and fight tumor cells. KEYTRUDA is a humanized monoclonal antibody that blocks the interaction between PD-1 and its ligands, PD-L1 and PD-L2, thereby activating T lymphocytes which may affect both tumor cells and healthy cells.
 
Favezelimab (MK-4280) is an investigational anti-lymphocyte activation gene-3 (LAG-3) antibody. LAG-3 is a cell surface immunomodulatory receptor expressed on various immune cells that down-regulates T cell proliferation and activation. Favezelimab aims to restore T cell effector function by preventing LAG-3 from binding to its primary ligand, major histocompatibility complex (MHC) class II molecules. The fixed-dose combination of favezelimab and pembrolizumab (MK-4280A) is being evaluated across multiple solid tumor types and in patients with relapsed or refractory classical Hodgkin lymphoma whose disease has progressed following prior anti-PD-1 therapy.

KEYTRUDA + favezelimab

Clesrovimab (MK-1654) 

Ovarian cancer

KEYTRUDA® (pembrolizumab)+ Paclitaxel & Carboplatin + KEYTRUDA® + LYNPARZA +/- Bevacizumab

Diffuse large B cell lymphoma

Zilovertamab (MK-2140)

Esophageal Squamous Cell Carcinoma

Ifinatamab deruxtecan is an investigational potential first-in-class B7-H3 directed ADC. Designed using Daiichi Sankyo’s proprietary DXd ADC Technology, ifinatamab deruxtecan is comprised of a humanized anti-B7-H3 IgG1 monoclonal antibody attached to a number of topoisomerase I inhibitor payloads (an exatecan derivative, DXd) via tetrapeptide-based cleavable linkers.

KEYTRUDA® plus paclitaxel +/- bevacizumab

Myelofibrosis

Autoimmune disease

Systemic sclerosis

PRA023 (Anti-TL1A mAb) 

Liver disease

Non-Alcoholic Fatty Liver Disease

MK-6024 is an investigational peptide and dual agonist at glucagon-like peptide 1 (GLP-1) and glucagon receptors in clinical development for the treatment of NASH.
MK-6024 was investigated in a randomized, active comparator-controlled, open-label Phase 2a study to evaluate the compound’s efficacy in liver fat reduction and safety in participants with nonalcoholic fatty liver disease. MK-6024 is administered subcutaneously once per week. Data from this study informed the design of the Phase 2b study that Merck plans to start in June 2023.
MK-6024 is being developed under an exclusive licensing agreement between Merck and Hanmi Pharmaceutical for the treatment of patients with NASH.

Efinopegdutide (MK-6024)

Belzutifan + cabozantinib

Platinum-resistant ovarian cancer

Raludotatug deruxtecan is an investigational specifically engineered potential first-in-class CDH6 directed DXd antibody-drug conjugate (ADC) discovered by Daiichi Sankyo and being jointly developed with Merck.

Raludotatug Deruxtecan 

Diabetic macular edema

Eye disease

Restoret (MK-3000, formerly EYE103) is an investigational, potentially first-in-class tetravalent, tri-specific Wnt antibody designed to address unmet medical need in patients with retinal diseases, including diabetic macular edema (DME) and neovascular age-related macular degeneration (NVAMD). MK-3000 is administered as an intravitreal injection seeking to eliminate vascular leakage in retinal diseases by agonizing the Wnt pathway with the goal of restoring and maintaining the blood-retinal barrier. Preclinical evidence indicates that agonizing the Wnt pathway in the retina may reduce vascular leakage.

Restoret (MK-3000, formerly EYE103)

Patritumab deruxtecan (HER3-DXd) 

Ifinatamab deruxtecan (I-DXd) is an investigational potential first-in-class B7-H3 directed ADC. Designed using Daiichi Sankyo’s proprietary DXd ADC Technology, ifinatamab deruxtecan is comprised of a humanized anti-B7-H3 IgG1 monoclonal antibody attached to a number of topoisomerase I inhibitor payloads (an exatecan derivative, DXd) via tetrapeptide-based cleavable linkers.
 
Ifinatamab deruxtecan was granted orphan drug designation by the U.S. Food and Drug Administration in <a href="https://www.accessdata.fda.gov/scripts/opdlisting/oopd/detailedIndex.cfm?cfgridkey=935123#:~:text=Generic%20Name%3A%20Ifinatamab%20deruxtecan%20Date%20Designated%3A%2004%2F26%2F2023%20Orphan,of%20small-cell%20lung%20cancer%20Orphan%20Designation%20Status%3A%20Designated">April 2023</a> and by the European Commission in <a href="https://ec.europa.eu/health/documents/community-register/html/reg_od_act.htm?sort=n">February 2024</a> for the treatment of SCLC.

HPN328 is a TriTAC that binds to human and non-human primate DLL3, CD3ε, and albumin with similar affinities.&nbsp;
DLL3 is a promising target for T-cell engagers because checkpoint inhibitors release T cells leading to increased patient survival, opportunity to treat checkpoint refractory or relapsed SCLC patients and potential for combinations with chemo and checkpoint therapies, and a high prevalence in SCLC.
<a href="https://ir.harpoontx.com/static-files/d084abcb-5be5-42f9-866d-53681ee4ce99">Source</a>

HPN328 (DLL3) +/- atezolizumab

Multiple myeloma

HPN217 is designed to bind to human BCMA, CD3, and albumin and redirects T cells to kill BCMA expressing target cells.&nbsp;

Merck & Co

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