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.
Autogene cevumeran
Solid Tumors
Advanced melanoma
Autogene cevumeran (RO7198457, RG6180) is a messenger RNA (mRNA) based personalized cancer vaccine. It is an individualized therapy designed and manufactured specifically to target each cancer patient's unique neoantigens (which result from tumor-specific mutations) to elicit an immune response against that patient's tumor.
Mechanism of Action / Target
Messenger RNA (mRNA) based personalized cancer vaccine; individualized neoantigen-specific immunotherapy (iNeST)
This program is being developed in collaboration with BioNTech.
Belvarafenib
Solid tumors
Belvarafenib (RG6185, GDC-5573, HM95573) is a selective small molecule inhibitor of 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.
Cevostamab
Multiple myeloma
Cevostamab (BFCR4350A, RG6160) is a T-cell engaging bispecific antibody designed to target FcRH5 on myeloma cells and CD3 on T-cells. This dual targeting is designed to activate and redirect T-cells to attack FcRH5-expressing myeloma cells.
Mechanism of Action / Target
T-cell engaging bispecific antibody, FcRH5 and CD3
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.
Giredestrant
ER+ HER2-negative breast cancer, adjuvant ER+ breast cancer
1L ER+ metatstatic breast cancer
Giredestrant (GDC-9545) 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
Glofitamab
Heme tumors
Diffuse large B-cell lymphoma
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Glofitamab (Anti-CD20 x CD3 TCB, RG6026) is a 2:1 format T cell-engaging bispecific antibody, designed to engage both CD20 on B cells and CD3 on T cells. By engaging both targets simultaneously, the antibody activates the T cells to attack and eliminate the B cells, demonstrating preclinical activity in B cell malignancies.
Mechanism of Action / Target
CD20xCD3 T-cell engaging bispecific antibody with bivalent binding to CD20 and monovalent binding to CD3 (2:1 format)
HER2/CD3 TDB
Metastatic HER2-expressing cancers
HER2xCD3 (BTRC4017A, RG6194) is a T-cell engaging bispecific antibody designed to target both HER2 on cancer cells and CD3 on T-cells. This dual targeting is designed to redirect T-cells to attack HER2-expressing cancer cells.
Mechanism of Action / Target
T-cell engaging bispecific antibody, HER2 and CD3
Inavolisib (GDC-0077)
Solid tumors and ER+ HER2-negative breast cancer
Inavolisib (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
Ipatasertib
Gastric 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
Follicular lymphoma
Heme tumors
Mosunetuzumab (Anti-CD20 x CD3 TDB, RG7828) is a humanized full-length T cell-dependent bispecific 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
CD20xCD3 T-cell engaging bispecific antibody with monovalent binding to CD20 and monovalent binding to CD3 (1:1 format)
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.
Status
This study was completed and published in Lancet Oncology Jan 2021
Polatuzumab vedotin
Diffuse large B-cell lymphoma
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Polatuzumab vedotin (RG7596) is an antibody-drug conjugate (ADC) that consists of a monoclonal antibody anti-CD79b, conjugated to a potent anti-cancer agent that is designed to selectively bind to CD79b on dividing B cells.
Mechanism of Action / Target
Anti-CD79b
Status
Tiragolumab
Non-small cell lung cancer
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Cervical cancer in combination with atezolizumab
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Squamous cell carcinoma of head and neck
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Small cell lung cancer
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Esophageal cancer
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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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2L + HER-2+ PD-L1+ mBC (KATE3)
HER2-positive early breast cancer high-risk patients (ASTEFANIA)
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
Acute myeloid lymphoma
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Multiple myeloma
Myelodysplastic syndromes
Venetoclax (RG7601) is a novel 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
Bcl-2 selective inhibitor
Status
This molecule is being developed in collaboration with AbbVie.
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-Tryptase
Asthma
MTPS9579A (RG6173) is an investigational medicine designed to target inflammation associated with asthma.
Mechanism of Action / Target
Tryptase
Managed by Genentech Research and Early Development
Astegolimab
Chronic Obstructive Pulmonary Disease
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.
Efmarodocokin alfa
Inflammatory diseases
Inflammatory bowel disease
aGVHD
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.
Managed by Genentech Research and Early Development
Etrolizumab
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.
Obinutuzumab
Lupus nephritis, membranous nephropathy and systemic lupus erythematosus
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Obinutuzumab, GA101, is a glycoengineered, type II, humanized anti-CD20 monoclonal antibody.
Omalizumab
Food Allergies
Omalizumab is a recombinant DNA-derived humanized IgG1 monoclonal antibody designed to selectively binds to human immunoglobulin E (IgE)
Mechanism of Action / Target
anti-IgE antibody
This molecule is being developed in collaboration with Novartis
RG6287
Inflammatory Bowel Disease
Managed by Genentech Research and Early Development.
RG6315
Immunologic disorders
Managed by Genentech Research and Early Development.
Bepranemab
Alzheimer’s disease
Bepranemab (RG6416), an anti-tau monoclonal antibody that targets extracellular tau in the brain, is being evaluated for the potential treatment of Alzheimer's disease (AD).
Mechanism of Action / Target
Anti-tau
This molecule is being developed in collaboration with UCB.
Brain shuttle gantenerumab
Alzheimer’s disease
Brain shuttle gantenerumab (RG6102) technology is designed to transfer gantenerumab across the blood brain barrier and increase antibody concentrations in the brain.
Managed by Pharma Research and Early Development.
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 (AD) and is proposed to be causative in the development of the disease.
Mechanism of Action / Target
Anti-amyloid beta (Abeta)
Managed by Roche Group.
This molecule is being developed in collaboration with AC Immune SA.
Fenebrutinib
Primary Progressive Multiple Sclerosis
Relapsing Multiple Sclerosis
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Fenebrutinib (RG7845) is an investigational oral medicine, designed to be a highly selective and reversible Bruton’s tyrosine kinase inhibitor (BTKi) that reduces both B-cell and myeloid lineage-cell activation.
Managed by Roche Group.
Gantenerumab
Alzheimer's disease
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Gantenerumab (RG1450) is a fully human monoclonal antibody designed to bind to aggregated forms of beta-amyloid and remove beta-amyloid plaques, a pathological hallmark of Alzheimer’s disease (AD) thought to lead to brain cell death.
Mechanism of Action / Target
Anti-amyloid beta (Abeta)
Managed by Roche Group.
This molecule is being developed in collaboration with MorphoSys.
Prasinezumab
Parkinson’s disease
Prasinezumab (RG7935) is a monoclonal antibody targeting alpha-synuclein, a protein that may misfold and be involved in the pathogenesis of Parkinson's disease (PD).
Managed by Pharma Research and Early Development.
This molecule is being developed in collaboration with Prothena.
Ralmitaront (RG7906)
Psychiatric disorders
Managed by Pharma Research and Early Development.
RG6091
Angelman syndrome
UBE3A-LNA is an investigational locked nucleic acid (LNA) being evaluated for the treatment of Angelman syndrome, which is caused by a lack of expression of the UBE3A gene. The LNA is designed to target the paternal antisense RNA and enable the expression of UBE3A in neurons.
Managed by Pharma Research and Early Development.
RG6182
Neurodegenerative diseases
Managed by Pharma Research and Early Development.
RG6237
Neuromuscular disorders
Managed by Pharma Research and Early Development.
RG7637
Neurodevelopmental disorders
Managed by Pharma Research and Early Development.
RG7816
Autism spectrum disorder
RG7816 (GABA-Aa5 PAM) is a small molecule positive allosteric modulator of the GABAA α5 receptor, which is expressed in key brain regions for autism spectrum disorder (ASD).
Managed by Pharma Research and Early Development.
Semorinemab
Alzheimer’s disease
Semorinemab (RG6100), an anti-tau monoclonal antibody that targets extracellular tau in the brain, is being evaluated for the potential treatment of Alzheimer's disease (AD).
Mechanism of Action / Target
Anti-tau
Managed by Genentech Research and Early Development. This molecule is being developed in collaboration with AC Immune SA.
Tenecteplase
Acute ischemic stroke
Tenecteplase (RG-3625) is a tissue plasminogen activator (tPA) that binds fibrin and converts plasminogen to plasmin. It is currently being evaluated in imaging-eligible, late-window acute ischemic stroke (AIS) patients.
Mechanism of Action / Target
Tissue plasminogen activator (tPA)
Managed by Genentech Inc., a member of the Roche Group
Tominersen
Huntington’s disease
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Tominersen (RG6042) is an antisense oligonucleotide (ASO) designed to target the underlying cause of Huntington’s disease (HD) by limiting production and lowering the levels of mutant huntingtin protein (mHTT), a toxic protein that causes brain cell death.
Mechanism of Action / Target
Antisense oligonucleotide (ASO)
Managed by Roche Group.
This molecule is being developed in collaboration with Ionis.
AT-527
COVID-19
Mechanism of Action / Target
Viral RNA polymerase inhibitor
Baloxavir marboxil
Influenza in children ages 12 and under
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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.
rhPentraxin-2
Idiopathic pulmonary fibrosis
Myelofibrosis
Mechanism of Action / Target
Recombinant human innate immunity protein pentraxin-2
Faricimab
Diabetic macular edema (DME)
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Wet age-related macular degeneration (AMD)
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Retinal vein occlusion (RVO)
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Faricimab (RG7716) is a bispecific antibody developed with CrossMab technology to tightly bind VEGF-A on one arm and angiopoietin (Ang)-2 on the other arm.
Mechanism of Action / Target
Vascular endothelial growth factor (VEGF) and Angiopoietin 2 (Ang-2)
IONIS-FB-LRx
Geographic atrophy (GA)
Mechanism of Action / Target
ASO Factor B
Ionis Pharmaceuticals; Roche In-License
Port Delivery System with ranibizumab
Wet age-related macular degeneration (AMD)
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Diabetic Macular Edema (DME)
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Diabetic Retinopathy without DME
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Ranibizumab, the active ingredient of 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.
Mechanism of Action / Target
Vascular endothelial growth factor (VEGF)
Partner with ForSight VISION4.
RG6120 (VEGF-Ang2 DutaFab)
Wet age-related macular degeneration (AMD)
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RG6120 (VEGF-Ang2 DutaFab) is a bispecific Fab molecule targeting vascular endothelial growth factor (VEGF) and Angiopoietin 2 (Ang-2).
Mechanism of Action / Target
Vascular endothelial growth factor (VEGF) and Angiopoietin 2 (Ang-2)
Status
Built on the DutaFab platform, RG6120 is specifically designed to be compatible with the Port Delivery System.
RG6147 (Anti-HtrA1)
Geographic atrophy (GA)
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Mechanism of Action / Target
HtrA Serine Peptidase 1
Managed by Genentech Research and Early Development.
RG6179
Diabetic macular edema (DME)
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RG6312
Geographic atrophy (GA)
Managed by Genentech Research and Early Development.
RG7774
Diabetic retinopathy
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RG7921
Wet age-related macular degeneration (AMD)
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Atezolizumab
Previously untreated metastatic triple-negative breast cancer (IMpassion130)
Previously untreated metastatic triple-negative breast cancer (IMpassion132)
Neoadjuvant triple negative breast cancer (IMpassion031)
Adjuvant triple negative breast cancer (IMpassion030)
*
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)
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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