Development Pipeline
Development pipeline (as of October 24, 2018)
Oncology
| Development code
(Compound number) |
Indication
# Additional indication |
Stage
(Date) |
Generic name
Product name Dosage form |
Origin Overseas name
(Collaborator) |
Mode of Action |
|---|---|---|---|---|---|
| GA101/RG7159
(RO5072759) |
Follicular lymphoma | Launched
(18/08) |
obinutuzumab
Gazyva® Injection |
Roche
Gazyva®/ Gazyvaro®(EU) (Nippon Shinyaku) |
Glycoengineered type II anti-CD20 monoclonal antibody |
| RG1273
(RO4368451) |
Breast cancer (adjuvant)
# |
Approved
(18/10) |
pertuzumab
Perjeta® Injection |
Roche
Perjeta® |
HER2 dimerization inhibitory humanized monoclonal antibody |
| RG7446
(MPDL3280A) |
Non-small cell lung cancer
(NSCLC) [1st line] # |
Filed
(18/03) |
atezolizumab
Tecentriq® Injection |
Roche
Tecentriq® |
Engineered anti-PDL1 monoclonal antibody |
| NSCLC (adjuvant)
# |
Phase III
Multinational study |
||||
| Small cell lung cancer
# |
Phase III
Multinational study |
||||
| Urothelial carcinoma
# |
Phase III
Multinational study |
||||
| Muscle invasive urothelial carcinoma (adjuvant)
# |
Phase III
Multinational study |
||||
| Renal cell carcinoma
# |
Phase III
Multinational study |
||||
| Renal cell carcinoma (adjuvant)
# |
Phase III
Multinational study |
||||
| Breast cancer
# |
Phase III
Multinational study |
||||
| Early breast cancer
# |
Phase III
Multinational study |
||||
| Ovarian cancer
# |
Phase III
Multinational study |
||||
| Prostate cancer
# |
Phase III
Multinational study |
||||
| Hepatocellular carcinoma
# |
Phase III
Multinational study |
||||
| Head and neck carcinoma (adjuvant)
# |
Phase III
Multinational study |
||||
| RG435
(RO4876646) |
Renal cell carcinoma
# |
Phase III
Multinational study |
bevacizumab
Avastin® Injection |
Roche
Avastin® |
Anti-VEGF (Vascular Endothelial Growth Factor) humanized monoclonal antibody |
| Hepatocellular carcinoma
# |
Phase III
Multinational study |
||||
| RG3502
(RO5304020) |
Breast cancer (adjuvant)
# |
Phase III
Multinational study |
trastuzumab emtansine
Kadcyla® Injection |
Roche
Kadcyla® |
Anti-HER2 antibody-tubulin polymerization inhibitor conjugate |
| RG7440
(GDC-0068) |
Prostate cancer | Phase III
Multinational study |
ipatasertib
Oral |
Roche/Array BioPharma | AKT inhibitor |
| Breast cancer | Phase III
Multinational study |
||||
| RG7596
(RO5541077) |
Diffuse large B-cell lymphoma
(DLBCL) |
Phase III
Multinational study |
polatuzumab vedotin
Injection |
Roche | Anti-CD79b antibody-drug conjugate |
| RG6264
(RO7198574) |
Breast cancer
(Fixed-dose combination, subcutaneous injection) |
Phase III
Multinational study |
trastuzumab/pertuzumab
Herceptin® / Perjeta® Injection |
Roche
Herceptin® / Perjeta® |
Anti-HER2 humanized monoclonal antibody/ HER2 dimerization inhibitory humanized monoclonal antibody |
| AF802 / RG7853
(CH5424802 / RO5424802) |
NSCLC (adjuvant)
# |
Phase III
Multinational study |
alectinib
Alecensa® Oral |
In-house
Alecensa® (Roche) |
ALK inhibitor |
| RG6268
(RXDX-101) |
NSCLC | Phase II
Multinational study |
entrectinib
Oral |
Roche / Nerviano Medical Sciences | ROS1/TRK inhibitor |
| Solid tumors | |||||
| GC33/RG7686
(GC33 / RO5137382) |
Hepatocellular carcinoma | Phase I
Multinational study* |
codrituzumab
Injection |
In-house
(Roche) |
Anti-Glypican-3 humanized monoclonal antibody |
| CKI27
(CKI27) |
Solid tumors | Phase I |
Oral |
In-house | Raf and MEK dual inhibitor |
| ERY974
(ERY974) |
Solid tumors | Phase I |
Injection |
In-house | Anti-Glypican-3/CD3 bispecific antibody |
| RG7421
(GDC-0973) |
Solid tumors | Phase I | cobimetinib
Oral |
Roche/Exelixis
Cotellic® |
MEK inhibitor |
| RG7802
(RO6958688) |
Solid tumors | Phase I |
Injection |
Roche | Anti-CEA/CD3 bispecific antibody |
| RG7828
(RO7030816) |
Hematologic tumors | Phase I |
Injection |
Roche | Anti-CD20/CD3 bispecific antibody |
* Multinational studies managed by Chugai
Bone and Joint Diseases
| Development code
(Compound number) |
Indication
# Additional indication |
Stage
(Date) |
Generic name
Product name Dosage form |
Origin
Overseas name (Collaborator) |
Mode of Action |
|---|---|---|---|---|---|
| ED-71
(ED-71) |
Osteoporosis | Filed
(18/02) China |
eldecalcitol
Edirol® Oral |
In-house | Activated vitamin D3 agent |
| NRD101
(NRD101) |
Knee osteoarthritis
/Shoulder periarthritis |
Phase III
China |
purified sodium hyaluronate
Suvenyl® Injection |
In-house | Sodium hyaluronate |
Renal Diseases
| Development code
(Compound number) |
Indication
# Additional indication |
Stage
(Date) |
Generic name
Product name Dosage form |
Origin
Overseas name (Collaborator) |
Mode of Action |
|---|---|---|---|---|---|
| EOS789
(EOS789) |
Hyperphosphatemia | Phase I |
Oral |
In-house | - |
Autoimmune Diseases
| Development code
(Compound number) |
Indication
# Additional indication |
Stage
(Date) |
Generic name
Product name Dosage form |
Origin Overseas name
(Collaborator) |
Mode of Action |
|---|---|---|---|---|---|
| MRA/RG1569
(RO4877533) |
Systemic sclerosis
# |
Phase III
Multinational study |
tocilizumab
Actemra® Injection |
In-house
Actemra®/ RoActemra® (EU) (Roche) |
Humanized anti-human IL-6 receptor monoclonal antibody |
| RG7845
(GDC-0853) |
Rheumatoid arthritis | Phase I | fenebrutinib
Oral |
Roche | BTK inhibitor |
Neurology
| Development code
(Compound number) |
Indication
# Additional indication |
Stage
(Date) |
Generic name
Product name Dosage form |
Origin
Overseas name (Collaborator) |
Mode of Action |
|---|---|---|---|---|---|
| RG1450
(RO4909832) |
Alzheimer’s disease | Phase III
Multinational study |
gantenerumab
Injection |
Roche/MorphoSys | Anti-amyloid-beta human monoclonal antibody |
| RG7412
(RO5490245) |
Alzheimer’s disease | Phase III
Multinational study |
crenezumab
Injection |
Roche/AC Immune | Anti-amyloid-beta humanized monoclonal antibody |
| SA237 / RG6168
(SA237) |
Neuromyelitis optica spectrum disorder (NMOSD) | Phase III
Multinational study* |
satralizumab
Injection |
In-house
(Roche) |
Anti-IL-6 receptor recycling antibody |
| RG6206
(BMS-986089) |
Duchenne muscular dystrophy (DMD) | Phase II/III
Multinational study |
Injection |
Roche/Bristol-Myers Squibb | Anti-myostatin adnectin |
| RG7916
(RO7034067) |
Spinal muscular atrophy (SMA) | Phase II
Multinational study |
risdiplam
Oral |
Roche/PTC Therapeutics | SMN2 splicing modifier |
| RG7935
(RO7046015) |
Parkinson’s disease | Phase I | prasinezumab
Injection |
Roche/Prothena | Anti-α-synuclein monoclonal antibody |
| GYM329 / RG70240 | Neuromuscular disease | Phase I |
Injection |
In-house
(Roche) |
‒ |
Others
| Development code
(Compound number) |
Indication
# Additional indication |
Stage
(Date) |
Generic name
Product name Dosage form |
Origin
Overseas name (Collaborator) |
Mode of Action |
|---|---|---|---|---|---|
| ACE910/ RG6013
(RO5534262) |
Hemophilia A
(Inhibitor) |
Launched
(18/05) Japan |
emicizumab
Hemlibra® Injection |
In-house
Hemlibra® (Roche) |
Anti-FIXa/FX bispecific antibody |
| Hemophilia A
(Non-inhibitor) |
Approved
(18/10) US |
||||
| Filed
(18/04) Japan |
|||||
| Filed
(18/04) Europe |
|||||
| RG7716
(RO6867461) |
Diabetic macular edema | Phase III
Multinational study |
faricimab
Injection |
Roche | Anti-VEFG/Ang2 bispecific antibody |
| Wet age-related macular degeneration | Phase I | ||||
| CIM331**
(CIM331) |
Pruritus in dialysis patients | Phase II | nemolizumab
Injection |
In-house
|
Anti-IL-31 receptor A humanized monoclonal antibody |
| SKY59/RG6107
(RO7112689) |
Paroxysmal nocturnal hemoglobinuria (PNH) |
Phase I/II
Multinational study |
Injection |
In-house
(Roche) |
Anti-C5 recycling antibody |
| PCO371
(PCO371) |
Hypoparathyroidism | Phase I |
Oral |
In-house | PTH1 receptor agonist |
| AMY109 | Endometriosis | Phase I |
Injection |
In-house | - |
** Development for atopic dermatitis: Out-licensed to Galderma (Overseas) and Maruho (Japan)
In principle, completion of first dose is regarded as the start of clinical studies in each phase.
