Pipeline
Rigorous and groundbreaking science has always been at the core of what we do at Genentech. Our R&D activities are focused on applying excellent science to discover and develop potential new medicines with the goal of becoming first-in-class or best-in-class therapeutics.
These compounds and their uses are investigational and have not been approved by the U.S. Food and Drug Administration. This information is presented only for purposes of providing a general overview of clinical trials and should not be construed as a recommendation for use of any product for unapproved uses.
Atezolizumab
Solid tumors
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Metastatic melanoma
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Anti-PDL1 (MPDL3280A, RG7446) is an engineered monoclonal antibody that targets the ligand PD-L1 (programmed death ligand 1).
Mechanism of Action / Target
Tumor immunotherapy, programmed death ligand 1 (PD-L1)
Status
A Phase I clinical trial evaluating anti-PDL1 for solid tumors, a Phase Ib clinical trial evaluating anti-PDL1 in combination with Avastin® (bevacizumab) for solid tumor, and a Phase I trial evaluating anti-PDL1 in combination with Zelboraf® (vemurafenib) for metastatic melanoma are ongoing. A Phase II trial evaluating anti-PDL1 in patients with metastatic non-small cell lung cancer is planned. For Avastin full prescribing information, including Boxed WARNINGS and additional important safety information, please visit http://www.avastin.com. For Zelboraf full prescribing information, including Medication Guide and important safety information, please visit http://www.zelboraf.com.
Cobimetinib
Solid tumors
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Metastatic melanoma
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GDC-0973 (RG7421), a selective inhibitor of MEK, also known as mitogen activated protein kinase kinase (MAPKK), is a key component of the RAS/RAF/MEK/ERK pathway, which is frequently activated in human tumors. Inappropriate activation of the MEK/ERK pathway promotes cell growth in the absence of exogenous growth factors.
Mechanism of Action / Target
Receptor tyrosine kinase signaling, mitogen-activated protein kinase (MEK) selective inhibitor
Status
A Phase III and a Phase Ib clinical trial in combination with Zelboraf® (vemurafenib) for metastatic melanoma; a Phase Ib clinical trial in combination with GDC-0068, an Akt Inhibitor, for solid tumors; and a Phase Ib clinical trial in combination with GDC-0941, a PI3 Kinase Inhibitor, for solid tumors are ongoing. A Phase I clinical trial evaluating GDC-0973 as a single agent in solid tumor is ongoing.GDC-0973 is being developed in collaboration with Exelixis, Inc. and Zelboraf is being developed in collaboration with Plexxikon, Inc. co-developed under a 2006 license and collaboration agreement between Roche/Genentech and Plexxikon, a member of the Daiichi Sankyo Group.For Zelboraf full prescribing information, including Medication Guide and important safety information, please visit http://www.zelboraf.com.
Entrectinib
Solid Tumors
Non-small cell lung cancer
Entrectinib (RXDX-101, RG6268) is a CNS-active tyrosine-kinase inhibitor being evaluated for the potential treatment of locally advanced or metastatic tumors that harbor NTRK or ROS1 gene rearrangements.
Mechanism of Action / Target
Neurotropic tropomyosin receptor kinase (NTRK) gene fusions; ROS proto-oncogene 1 (ROS1) gene fusions
This molecule was obtained through the acquisition of Ignyta.
HER2/CD3 TDB
Metastatic HER2-expressing cancers
Anti HER2/CD3 (BTRC4017A, RG6194) is a T cell–dependent bispecific (TDB) antibody designed to target both HER2 on cancer cells and CD3 on T cells. This dual targeting antibody is designed to redirect T cells to attack HER2-expressing cancer cells.
Mechanism of Action / Target
T cell–dependent bispecific (TDB), HER2-expressing cancers
Idasanutlin
Polycythemia vera
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Acute myeloid leukemia
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Idasanutlin (RG7388) is a small molecule MDM2 antagonist being evaluated for the potential treatment of polycythemia vera and relapsed or refractory acute myeloid leukemia.
Mechanism of Action / Target
Mouse double minute 2 homolog (MDM2)
Ipatasertib
HR+ positive breast cancer
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Gastric cancer
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Triple negative breast cancer
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Prostate cancer
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Ipatasertib (GDC-0068, RG7440) is a small molecule pan-Akt inhibitor. The PI3K/Akt/mTOR pathway regulates cell growth and survival.
Mechanism of Action / Target
Receptor tyrosine kinase signaling, Akt pan-inhibitor
This molecule was discovered in collaboration with Array BioPharma Inc.
Mosunetuzumab
Hematologic malignancies
Anti-CD20/CD3 (BTCT4465A, RG7828) is a humanized full-length T cell–dependent bispecific (TDB) antibody designed to target both CD20 on B cells and CD3 on T cells. This dual targeting antibody is designed to redirect T cells to attack cancer cells.
Mechanism of Action / Target
T cell–dependent bispecific (TDB), CD20 expressing B-Cell malignancies
New Molecular Entity
Multiple myeloma
BFCR4350A (RG6160) is an investigational medicine being evaluated for the potential treatment of relapsed or refractory multiple myeloma.
New Molecular Entity
Acute myeloid leukemia
DCLL9718S (RG6109) is an investigational medicine being evaluated for the potential treatment of relapsed or refractory acute myeloid leukemia.
New Molecular Entity
HER2+ breast cancer
DHES0815A (RG6148) is an investigational medicine being evaluated for the potential treatment of metastatic HER2-positive breast cancer.
Obinutuzumab
Diffuse large B-cell lymphoma
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Front-line indolent non-Hodgkin's lymphoma
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Refractory indolent Non Hodgkin's lymphoma
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Obinutuzumab, GA101, is a glycoengineered, type II, humanized anti-CD20 monoclonal antibody. It was specifically designed to selectively target the CD20 protein on malignant B-cells.
Personalized Cancer Vaccine
Solid Tumors
RO7198457 (RG6180) is a messenger RNA (mRNA) based individually tailored, personalized cancer vaccine. Each vaccine will be made using unique neoantigen signatures from an individual patient’s tumor, which is expected to elicit an effective immune response against that patient's tumor.
Mechanism of Action / Target
Vaccines; messenger RNA (mRNA) based
Status
This program is being developed in collaboration with BioNTech.
Pertuzumab
Early HER2-positive breast cancer in combination with trastuzumab emtansine
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Early and metastatic HER2-positive breast cancer in combination with atezolizumab
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Pertuzumab (Perjeta) is a humanized monoclonal antibody designed to prevent HER2 dimerisation, a process that is believed to play an important role in the growth and formation of several different cancer types.
For Perjeta full prescribing information, including Boxed WARNINGS, Medication Guide and additional important safety information, please visit http://www.perjeta.com or call:1-888-249-4918.
PI3K Inhibitor (GDC-0077)
Solid tumors and ER+ HER2-negative breast cancer
GDC-0077 (RG6114) is a small molecule PI3 kinase (PI3K) inhibitor. Dysregulation of PI3K signaling is implicated in a broad range of human cancers and activating mutations in the PI3K alpha-isoform gene (PIK3CA) are common oncogenic drivers. The PI3K/Akt/mTOR pathway regulates cell growth and survival.
Mechanism of Action / Target
Receptor tyrosine kinase signaling, phosphoinositide 3-kinase (PI3K) inhibitor
Polatuzumab vedotin
Non-Hodgkin's lymphoma and diffuse large B-cell lymphoma
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Polatuzumab vedotin (Anti-CD79b, DCDS4501A, RG7596) is an antibody drug conjugate (ADC) composed of a monoclonal antibody directed against CD79b, link to the small molecule, cytotoxic, microtubule-disrupting agent, monomethyl auristatin E (MMAE). Polatuzumab vedotin is designed to selectively bind to CD79b on hematologic cells.
Mechanism of Action / Target
Antibody drug conjugate; anti-CD79b
Status
A Phase II clinical trial evaluating either pinatuzumab vedotin or polatuzumab vedotin in combination with Rituxan® (Rituximab) for relapsed or refractory follicular non-Hodgkin's lymphoma and relapsed or refractory diffuse large B-cell lymphoma is ongoing.
This molecule is being developed utilizing Seattle Genetics' ADC technology.
For Rituxan full prescribing information, including Boxed WARNINGS, Medication Guide and additional important safety information, please visit http://www.rituxan.com or call 1-800-821-8590.
RAF Inhibitor (GDC-5573)
Solid tumors
GDC-5573 (HM95573, RG6185) is a selective small molecule inhibitor of the RAF family kinases designed to inhibit the MAPK pathway, which is frequently activated in human tumors and drives tumor growth.
Mechanism of Action / Target
Rapidly accelerated fibrosarcoma (RAF) kinase; mitogen activated protein kinases (MAPK)
This molecule is being developed in collaboration with Hanmi Pharmaceutical.
SERD (GDC-9545)
ER+ HER2-negative breast cancer
GDC-9545 (RG6171) is a selective estrogen receptor degrader (SERD) that is designed to bind to the estrogen receptor to limit its function. In addition, when SERDs bind to the estrogen receptor, they may be able to change the shape of the receptor in such a way that the cell eliminates it by degradation.
Mechanism of Action / Target
Selective estrogen receptor degrader
Tiragolumab
Non-small cell lung cancer
Solid tumors
Tiragolumab (anti-TIGIT, MTIG7192A, RG6058) is a fully human monoclonal antibody designed to bind to TIGIT and prevent its interaction with poliovirus receptor (PVR).
Mechanism of Action / Target
T cell immunoglobulin and ITIM domain protein (TIGIT), a member of the immunoglobulin super family, is a novel immune inhibitory receptor
Trastuzumab emtansine
1st line HER2-positive metastatic breast cancer
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Early HER2-positive breast cancer in combination with pertuzumab
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Early and metastatic HER2-positive breast cancer in combination with atezolizumab
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3rd line HER2-positive metastatic breast cancer
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Trastuzumab emtansine (T–DM1) is a novel antibody–drug conjugate that is designed to specifically target cells over expressing HER2. It is being tested in a variety of HER2 positive cancers.
Vemurafenib
Papillary thyroid cancer, BRAF mutation positive
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Metastatic melanoma, BRAF mutation positive
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Vemurafenib (Zelboraf) is an oral, small molecule, BRAF kinase inhibitor. The BRAF protein is a key component of the RAS-RAF pathway involved in normal cell growth and survival. Mutations that keep the BRAF protein in an active state may cause excessive pathway signalling, leading to uncontrolled cell growth and survival.
Please see accompanying full Prescribing Information and Medication Guide for additional important safety information.
Venetoclax
Chronic lymphocytic leukemia and non-Hodgkin's lymphoma
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GDC-0199 (RG7601) is a small molecule Bcl-2 selective inhibitor designed to restore apoptosis, also known as programmed cell death, by blocking the function of a pro-survival Bcl-2 family protein. The Bcl-2 family proteins, which are expressed at high levels in many tumors, play a central role in regulating apoptosis.
Mechanism of Action / Target
Apoptosis, Bcl-2 selective inhibitor
Status
A Phase I trial evaluating GDC-0199 for chronic lymphocytic leukemia and non-Hodgkin's lymphoma is ongoing, and a Phase I trial evaluating GDC-0199 in combination with Rituxan® (Rituximab) for non-Hodgkin's lymphoma is planned.
This molecule is being developed in collaboration with AbbVie.
For Rituxan full prescribing information, including Boxed WARNINGS, Medication Guide and additional important safety information, please visit http://www.rituxan.com or call 1-800-821-8590.
Vismodegib
Operable basal cell carcinoma
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Vismodegib(Erivedge) is an oral, small molecule designed to selectively inhibit abnormal signaling in the Hedgehog pathway. It is being tested in a variety of cancers.
For Erivedge full prescribing information, including Boxed WARNINGS, Medication Guide and additional important safety information, please visit http://www.erivedge.com or call 1-855-737-4833.
Anti-ST2 MAb
Asthma
Anti-ST2 (MSTT1041A, AMG 282, RG6149) is a fully human monoclonal antibody designed to inhibit binding of interleukin-33 (IL-33) to the ST2 receptor.
Mechanism of Action / Target
ST2 receptor; Interleukin-33 (IL-33)
This molecule was in-licensed from Amgen.
Etrolizumab
Ulcerative colitis and Crohn's disease
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Etrolizumab (rhuMAb Beta7, RG7413) is a humanized IgG1 MAb targeting the beta 7 integrin subunit. It binds to two integrins, alpha4beta7 and alphaEbeta7. These integrins are required for lymphocyte trafficking and retention, respectively, in the gastrointestinal tract and appear to play a role in inflammatory bowel diseases.
Mechanism of Action / Target
Anti-Beta7 integrin subunit
Status
Phase III clinical trials evaluating etrolizumab in ulcerative colitis are ongoing; Phase III clinical trials in Crohn's disease are ongoing.
Fenebrutinib
Rheumatoid arthritis
Systemic lupus erythematosus
Chronic spontaneous urticaria
Fenebrutinib (GDC-0853, RG7845) is an orally administered Bruton’s tyrosine kinase (BTK) inhibitor designed to block B cell proliferation and the resulting excessive immune response seen in autoimmune disorders.
Mechanism of Action / Target
Bruton’s tyrosine kinase inhibitor
GDC-3280
Interstitial lung disease
IL22-Fc
Inflammatory diseases
Inflammatory bowel disease
Diabetic foot ulcer
IL22-Fc (UTTR1147A, RG7880) is a recombinant human protein with potential application across multiple inflammatory and metabolic diseases.
Mechanism of Action / Target
Interleukin-22 (IL-22), a member of the IL-10 family of cytokines that activates IL-22R signaling; fusion protein
Lebrikizumab
Idiopathic pulmonary fibrosis
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Lebrikizumab is a novel humanized monoclonal antibody designed to specifically block the action of the interleukin-13 cytokine (a signalling protein that serves as a messenger between cells that is increased in some patients with asthma).
New Molecular Entity
Asthma
MTPS9579A (RG6173) is an investigational medicine designed to target inflammation associated with asthma.
New Molecular Entity
Asthma
GDC-0214 (RG6151) is an orally administered investigational medicine being evaluated for the potential treatment of asthma.
New Molecular Entity
Inflammatory disease
GDC-0334 (RG6174) is an orally administered investigational medicine being evaluated for the potential treatment of inflammatory disease.
Obinutuzumab
Lupus nephritis and end-stage renal disease
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Obinutuzumab, GA101, is a glycoengineered, type II, humanized anti-CD20 monoclonal antibody.
Omalizumab
Nasal Polyps
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Omalizumab is a recombinant DNA-derived humanized IgG1 monoclonal antibody designed to selectively binds to human immunoglobulin E (IgE)
Tocilizumab
Systemic sclerosis
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Tocilizumab (Actemra/RoACTEMRA) is a humanised monoclonal antibody to the interleukin-6 receptor, inhibiting the activity of interleukin-6 , a protein that plays a major role in the rheumatoid arthritis inflammation process. For Actemra full prescribing information, including Boxed WARNINGS, Medication Guide and additional important safety information, please visit http://www.actemra.com or call 1-800-FDA-1088.
Anti-Myostatin Adnectin
Duchenne Muscular Dystrophy
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RG6206 (BMS-986089), an investigation medicine designed to bind to myostatin, is being evaluated for the potential treatment of Duchenne muscular dystrophy.
Mechanism of Action / Target
Myostatin-inhibiting adnectin fusion protein
This molecule is being developed in collaboration with Bristol-Myers Squibb.
Anti-Tau
Alzheimer’s Disease
RO7105705 (RG6100) is an investigational medicine being evaluated for the potential treatment of Alzheimer’s disease.
Mechanism of Action / Target
Tau
This molecule is being developed in collaboration with AC Immune SA.
Balovaptan
Autism
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Balovaptan (RG7314), a small molecule antagonist of the V1A vasopressin receptor (V1AR) in the brain, is being evaluated for the potential treatment of Autism Spectrum Disorders (ASD).
Mechanism of Action / Target
V1A vasopressin receptor (V1AR) antagonist
Crenezumab
Alzheimer's Disease
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Crenezumab (Anti-Abeta, MABT5102A, RG7412) is a humanized monoclonal antibody, which binds to amyloid beta (Abeta). Abeta is the main constituent of amyloid plaque in the brains of patients with Alzheimer's disease and is proposed to be causative in the development of the disease.
Mechanism of Action / Target
Anti-amyloid beta (Abeta)
This molecule is being developed in collaboration with AC Immune SA.
DLK Inhibitor (GDC-0134)
Amyotrophic lateral sclerosis
GDC-0134 (RG6000) is a small molecule dual leucine zipper kinase (DLK) inhibitor being evaluated for the potential treatment of amyotrophic lateral sclerosis. DLK is a neuronally-enriched kinase that is designed to mediate stress-induced cell death. DLK inhibition may exhibit neuroprotective potential.
Mechanism of Action / Target
Dual leucine zipper kinase (DLK)
Gantenerumab
Alzheimer's Disease
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Gantenerumab is a fully human monoclonal antibody that binds and neutralises disease-relevant aggregated forms of amyloid-beta: those that accumulate as plaques in the brain and those which interfere with brain-cell functioning.
SMN2 Splicing Modifier
Spinal muscular atrophy
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RG7916, a small molecule survival motor neuron 2 (SMN2) splicing modifier designed to increase levels of SMN protein, is being evaluated for the potential treatment of spinal muscular atrophy – a rare and debilitating genetic neuromuscular disease that is most commonly diagnosed in children.
Mechanism of Action / Target
Survival motor neuron 2 (SMN2) mRNA splicing modifier
The molecule is being developed in collaboration with PTC Therapeutics and the SMA Foundation.
Anti-S. aureus TAC
Staphylococcus aureus infections
Anti-S. aureus TAC (DSTA4637S, RG7861) is a THIOMAB™ antibiotic conjugate (TAC) that consists of a human monoclonal antibody directed against Staphylococcus aureus, conjugated to an antiobiotic agent. Anti-S. aureus TAC is designed to bind to the surface of Staphylococcus aureus bacteria.
Mechanism of Action / Target
THIOMAB antibiotic conjugate (TAC); Staphylococcus aureus
This molecule was developed utilizing Seattle Genetics' antibody drug conjugate (ADC) technology and the antibody was discovered in collaboration with Symphogen.
Baloxavir marboxil
Influenza
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Baloxavir marboxil (S-033188, RG6152), a small molecule cap-dependent endonuclease inhibitor, is being evaluated for the potential treatment of seasonal influenza A and B viruses.
Mechanism of Action / Target
Cap-dependent endonuclease inhibitor
This molecule is being developed in collaboration with Shionogi Co.
New Molecular Entity
Geographic atrophy
RO7171009 (RG6417) is an investigational medicine being evaluated for the potential treatment of geographic atrophy.
Ranibizumab
Sustained delivery age-related macular degeneration
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Ranibizumab: ranibizumab (Lucentis) is a monoclonal antibody fragment. It is designed to bind to and inhibit VEGF (vascular endothelial growth factor), a protein that is believed to play a critical role in the formation of new blood vessels (angiogenesis) and the hyperpermeability (leakiness) of the vessels. Ranibizumab is being tested for sustained delivery in wet AMD.
For Lucentis full prescribing information, including Boxed WARNINGS, Medication Guide and additional important safety information, please visit http://www.lucentis.com/lucentis/ or call 1-866-724-9394.
Emicizumab
Hemophilia A
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Emicizumab (RG6013, ACE910) is a bispecific monoclonal antibody designed to replace the function of activated factor VIII, an essential protein in the blood clotting process.
Emicizumab was created by Chugai Pharmaceutical Co., Ltd. and is being co-developed by Chugai, Roche and Genentech.
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