Development Pipeline

View the status of our current development pipeline as of October 22, 2020.

Development Pipeline (all disease areas) [PDF 167KB]

Oncology

Development code Indication
# Additional
indication
Stage
(Date)
Generic name
Product name
Dosage form
Origin Overseas name
(Collaborator)
Mode of Action
RG7446 Hepatocellular carcinoma
#
Approved
(20/09)
atezolizumab
Tecentriq
Injection
Roche
Tecentriq
Engineered anti-PD-L1 monoclonal antibody
NSCLC (adjuvant)
#
Phase III
NSCLC (neoadjuvant)
#
Phase III
NSCLC (stage III)
#
Phase III
(in combination with RG6058)
Urothelial carcinoma
#
Phase III
Renal cell carcinoma (adjuvant)
#
Phase III
Renal cell carcinoma (2nd Line)
#
Phase III
(in combination with cabozantinib)
Roche
Tecentriq
(Takeda)
Early breast cancer
#
Phase III Roche
Tecentriq
Ovarian cancer
#
Phase III
Hepatocellular carcinoma (adjuvant)
#
Phase III
Head and neck carcinoma (adjuvant)
#
Phase III
Esophageal cancer
#
Phase III
(in combination with RG6058)
RG3502 Breast cancer (adjuvant)
#
Approved
(20/08)
trastuzumab emtansine
Kadcyla
Injection
Roche
Kadcyla
Anti-HER2 antibody-tubulin polymerization inhibitor conjugate
RG435 Hepatocellular carcinoma
#
Approved
(20/09)
(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)
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
Phesgo
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
(in combination with RG7446)
tiragolumab

Injection
Roche Anti-TIGIT human monoclonal antibody
NSCLC Phase III
(in combination with RG7446)
NSCLC (stage III) Phase III
(in combination with RG7446)
Esophageal cancer Phase III
(in combination with RG7446)
RG6171 Breast cancer Phase III

Oral
Roche SERD (Selective Estrogen Receptor Degrader)
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 Anti-CD137 agonistic Switch antibody
SPYK04 Solid tumors Phase I

Oral
In-house -

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) Launched
(20/08)
Japan
satralizumab
Enspryng
Injection
In-house
Enspryng
(Roche)
pH-dependent binding humanized anti-IL-6 receptor monoclonal antibody
Approved
(20/08)
US
Filed
(19/08)
EU
RG7916 Spinal muscular atrophy (SMA) Filed
(20/10)
risdiplam

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

Oral
Roche Partial TAAR1 agonist
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

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 III 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.

  • Like
  • Tweet
  • LINE it!
  • E-mail

Reports & Downloads

Back to top