Development Pipeline

View the status of our current development pipeline as of July 27, 2020.

Development Pipeline (all disease areas) [PDF 191KB]

Oncology

Development code Indication
# Additional
indication
Stage
(Date)
Generic name
Product name
Dosage form
Origin Overseas name
(Collaborator)
Mode of Action
RG6268 Non-small cell lung cancer (NSCLC)
#
Approved
(20/02)
entrectinib
Rozlytrek
Oral
Roche / Nerviano Medical Sciences ROS1/TRK inhibitor
RG7446 Hepatocellular carcinoma
#
Filed
(20/02)
atezolizumab
Tecentriq
Injection
Roche
Tecentriq
Engineered anti-PD-L1 monoclonal antibody
NSCLC (adjuvant)
#
Phase III
NSCLC (neoadjuvant)
#
Phase III
Urothelial carcinoma
#
Phase III
Renal cell carcinoma (adjuvant)
#
Phase III
Early breast cancer
#
Phase III
Ovarian cancer
#
Phase III
Hepatocellular carcinoma (adjuvant)
#
Phase III
Head and neck carcinoma (adjuvant)
#
Phase III
Renal cell carcinoma
#
Development
discontinued
RG3502 Breast cancer (adjuvant)
#
Filed
(19/08)
trastuzumab emtansine
Kadcyla
Injection
Roche
Kadcyla
Anti-HER2 antibody-tubulin polymerization inhibitor conjugate
RG435 Hepatocellular carcinoma
#
Filed
(20/02)
(in combination with RG7446)
bevacizumab
Avastin
Injection
Roche
Avastin
Anti-VEGF (Vascular Endothelial Growth Factor) humanized monoclonal antibody
Hepatocellular carcinoma (adjuvant)
#
Phase III
(in combination with RG7446)
Small cell lung cancer (SCLC)
#
Phase III
(in combination with RG7446)
Renal cell carcinoma
#
Development
discontinued
(in combination with RG7446)
RG7596 Relapsed or refractory diffuse large B-cell lymphoma (DLBCL) Filed
(20/06)
polatuzumab vedotin

Injection
Roche/Seattle Genetics
Polivy
Anti-CD79b antibody-drug conjugate
Diffuse large B-cell lymphoma
(DLBCL)
Phase III
RG7440 Prostate cancer Phase III ipatasertib

Oral
Roche/Array BioPharma AKT inhibitor
Breast cancer Phase III
RG6264 Breast cancer
(Fixed-dose combination, subcutaneous injection)
Phase III trastuzumab/pertuzumab
Herceptin/Perjeta
Injection
Roche
Herceptin/Perjeta
Anti-HER2 humanized monoclonal antibody/HER2 dimerization inhibitory humanized monoclonal antibody
AF802 / RG7853 NSCLC (adjuvant)
#
Phase III alectinib
Alecensa
Oral
In-house
Alecensa
(Roche)
ALK inhibitor
RG6058 SCLC Phase III tiragolumab

Injection
Roche Anti-TIGIT human monoclonal antibody
NSCLC Phase III
OBP-301 Esophageal cancer Phase II  
 
Injection
Oncolys BioPharma Oncolytic type 5 adenovirus
GC33 Hepatocellular carcinoma Phase I codrituzumab
 
Injection
In-house Anti-Glypican-3 humanized monoclonal antibody
ERY974 Solid tumors Phase I

Injection
In-house Anti-Glypican-3/CD3 bispecific antibody
RG7421 Solid tumors Phase I cobimetinib

Oral
Roche/Exelixis
Cotellic
MEK inhibitor
RG7802 Solid tumors Phase I cibisatamab

Injection
Roche Anti-CEA/CD3 bispecific antibody
RG7828 Hematologic tumors Phase I mosunetuzumab

Injection
Roche Anti-CD20/CD3 bispecific antibody
RG6026 Hematologic tumors Phase I glofitamab

Injection
Roche Anti-CD20/CD3 bispecific antibody
RG7461 Solid tumors Phase I

Injection
Roche Anti-FAP humanized antibody-engineered IL-2 variant fusion protein
AMY109 Solid tumors Phase I

Injection
In-house -
STA551 Solid tumors Phase I

Injection
In-house -
RG6171 Breast cancer Phase I

Oral
Roche SERD (Selective Estrogen Receptor Downregulator)

Bone and Joint Diseases

Development code Indication
# Additional
indication
Stage
(Date)
Generic name
Product name
Dosage form
Origin
Overseas name
(Collaborator)
Mode of Action
ED-71 Osteoporosis Filed
(18/02)
China
eldecalcitol
Edirol
Oral
In-house Activated vitamin D3 agent
NRD101 Knee osteoarthritis
/Shoulder periarthritis
Phase III
China
purified sodium hyaluronate
Suvenyl
Injection
In-house Sodium hyaluronate

Renal Diseases

Development code Indication
# Additional
indication
Stage
(Date)
Generic name
Product name
Dosage form
Origin
Overseas name
(Collaborator)
Mode of Action
EOS789 Hyperphosphatemia Phase I

Oral
In-house -

Autoimmune Diseases

Development code Indication
# Additional
indication
Stage
(Date)
Generic name
Product name
Dosage form
Origin
Overseas name
(Collaborator)
Mode of Action
RG7845 Rheumatoid arthritis Phase I fenebrutinib

Oral
Roche BTK inhibitor
RG7880 Inflammatory bowel disease Phase I

Injection
Roche Human IL-22 fusion protein

Neurology

Development code Indication
# Additional
indication
Stage
(Date)
Generic name
Product name
Dosage form
Origin
Overseas name
(Collaborator)
Mode of Action
SA237 / RG6168 Neuromyelitis optica spectrum disorder (NMOSD) Approved
(20/06)
Japan
satralizumab
Enspryng
Injection
In-house
Enspryng
(Roche)
Anti-IL-6 receptor recycling antibody
Filed
(19/08)
US
Filed
(19/08)
EU
RG1450 Alzheimer’s disease Phase III gantenerumab

Injection
Roche/MorphoSys Anti-amyloid-beta human monoclonal antibody
RG6042 Huntington’s disease Phase III tominersen

Injection
Roche/Ionis Pharmaceuticals Antisense oligonucleotide targeting HTT mRNA
RG7916 Spinal muscular atrophy (SMA) Phase II/III risdiplam

Oral
Roche/PTC Therapeutics SMN2 splicing modifier
RG7906 Schizophrenia Phase II ralmitaront

Oral
Roche -
RG7935 Parkinson’s disease Phase I prasinezumab

Injection
Roche/Prothena Anti-α-synuclein monoclonal antibody
GYM329 / RG6237 Neuromuscular disease Phase I

Injection
In-house

(Roche)
Anti-latent myostatin sweeping antibody
RG6100 Alzheimer’s disease Phase I semorinemab

injection
Roche/AC Immune Anti-tau humanized monoclonal antibody
RG7314 Autism spectrum disorder Development
discontinued
balovaptan

Oral
Roche Vasopressin 1a receptor antagonist

Other diseases

Development code Indication
# Additional
indication
Stage
(Date)
Generic name
Product name
Dosage form
Origin
Overseas name
(Collaborator)
Mode of Action
MRA/RG1569 COVID-19 pneumonia
#
Phase III*
Japan
tocilizumab
Actemra
Injection
In-house
Actemra/RoActemra (EU)
Humanized anti-human IL-6 receptor monoclonal
antibody
RG7716 Diabetic macular edema Phase III faricimab

Injection
Roche Anti-VEGF/Ang2 bispecific antibody
Neovascular age related macular degeneration (nAMD) Phase III
ACE910/RG6013 Acquired hemophilia A
#
Phase III
Japan
emicizumab
Hemlibra
Injection
In-house
Hemlibra
Anti-coagulation factor IXa/X humanized bispecific monoclonal antibody
SKY59/RG6107 Paroxysmal nocturnal hemoglobinuria
(PNH)
Phase I/II crovalimab
 
Injection
In-house
 
(Roche)
Anti-C5 recycling antibody
NXT007 Hemophilia A Phase I/II

Injection
In-house Anti-coagulation factor IXa/X bispecific antibody
PCO371 Hypoparathyroidism Phase I  
 
Oral
In-house PTH1 receptor agonist
AMY109 Endometriosis Phase I  
 
Injection
In-house -

In principle, completion of first dose is regarded as the start of clinical studies in each phase.
*: Roche is conducting global Phase III studies of Actemra/RoActemra against COVID-19 pneumonia separately.

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