Last checked at 6 Nov 2014 07:00
ASTRAZENECA DEVELOPMENT PIPELINE, 30 SEPTEMBER 2014
Phase III / Pivotal / Registration
NMEs and significant additional indications
Submission dates shown for assets in Phase III and beyond. As disclosure of compound information is balanced by the business need to maintain confidentiality, information in relation to some compounds listed here has not been disclosed at this time.
Compound | Mechanism | Area Under Investigation | Date Commenced Phase | Estimated Filing | |||
US | EU | Japan | China | ||||
Cardiovascular and Metabolism | |||||||
Brilinta/ Brilique1 | ADP receptor antagonist | arterial thrombosis | Launched | Launched | Filed | Launched | |
Epanova# | omega-3 free fatty acids | hypertriglyceridaemia | Approved | ||||
Farxiga / Forxiga2 | SGLT-2 inhibitor | Type 2 diabetes | Launched | Launched | Launched | Filed | |
Myalept | leptin analogue | lipodystrophy | Launched | 2015 | N/A | ||
roxadustat# | hypoxia- inducible factor inhibitor | anaemia in CKD / ESRD | Q3 2014 | 2018 | N/A | N/A | 2016 |
Oncology | |||||||
AZD9291 | EGFR tyrosine kinase inhibitor | advanced EGFRm T790M NSCLC | Q2 2014 | 2015 | 2015 | 2015 | 2017 |
Caprelsa | VEGFR / EGFR tyrosine kinase inhibitor with RET kinase activity | medullary thyroid cancer | Launched | Launched | Q4 2014 | Filed | |
MEDI4736# PACIFIC | anti-PD-L1 MAb | stage III NSCLC | Q2 2014 | 2017 | 2020 | 2020 | |
MEDI4736# ATLANTIC¶ | anti-PD-L1 MAb | 3rd line NSCLC | Q1 2014 | 2016 | 2017 | 2017 | |
moxetumomab pasudotox# | anti-CD22 recombinant immunotoxin | hairy cell leukaemia | Q2 2013 | 2018 | 2018 | ||
Lynparza (olaparib) | PARP inhibitor | BRCAm PSR ovarian cancer | Filed | Filed7# | |||
Lynparza (olaparib)SOLO-1 | PARP inhibitor | 1st line BRCAm ovarian cancer | Q3 2013 | 2017 | 2017 | 2017 | 2018 |
Lynparza (olaparib) SOLO-2 | PARP inhibitor | BRCAm PSR ovarian cancer | Q3 2013 | 2016 | 2016 | 2016 | 2016 |
Lynparza (olaparib) GOLD | PARP inhibitor | 2nd line gastric cancer | Q3 2013 | 2017 | 2018 | ||
Lynparza (olaparib) OlympiA | PARP inhibitor | adjuvant breast cancer | Q2 2014 | 2020 | 2020 | 2020 | 2021 |
Lynparza (olaparib) OlympiAD | PARP inhibitor | metastatic breast cancer | Q2 2014 | 2016 | 2016 | 2016 | |
selumetinib# SELECT-1 | MEK inhibitor | 2nd line KRAS+ NSCLC | Q4 2013 | 2017 | 2017 | ||
selumetinib# ASTRA | MEK inhibitor | differentiated thyroid cancer | Q3 2013 | 2017 | 2017 | ||
selumetinib# SUMIT | MEK inhibitor | uveal melanoma | Q2 2014 | 2015 | 2015 | ||
tremelimumab¶ | anti-CTLA-4 MAb | mesothelioma | Q2 2014 | 2016 | 2016 | 2016 | |
Phase III / Pivotal / Registration (continued)
Compound | Mechanism | Area Under Investigation | Date Commenced Phase | Estimated Filing | |||
US | EU | Japan | China | ||||
Respiratory, Inflammation and Autoimmunity | |||||||
benralizumab# CALIMA, SIROCCO, ZONDA | anti-IL-5R MAb | severe asthma | Q4 2013 | 2016 | 2016 | ||
benralizumab# TERRANOVA, GALATHEA | anti-IL-5R MAb | COPD | Q3 20144 | 2018 | 2018 | ||
brodalumab# AMAGINE-1,2,3 | anti-IL-17R MAb | psoriasis | Q3 2012 | ++ | ++ | ||
brodalumab# AMVISION-1,2 | anti-IL-17R MAb | psoriatic arthritis | Q1 2014 | ++ | ++ | ||
Lesinurad3 CLEAR 1,2 CRYSTAL | selective uric acid reabsorption inhibitor (SURI) | chronic treatment of patients with gout | Q4 2011 | Q4 2014 | Q4 2014 | ||
PT003 GFF | LAMA / LABA | COPD | Q2 2013 | 2015 | 2016 | 2017 | 2017 |
PT001 GP | LAMA | COPD | Q2 2013 | 2016 | 2016 | 2017 | 2017 |
tralokinumab STRATOS 1-2 TROPOS | anti-IL-13 MAb | severe asthma | Q3 2014 | 2018 | 2018 | 2018 | |
Infection | |||||||
CAZ AVI#4 RECLAIM | cephalosporin / beta lactamase inhibitor | serious infections | Q1 2012 | N/A | 2015 | 2016 | |
CAZ AVI#4 REPROVE | cephalosporin / beta lactamase inhibitor | hospital-acquired pneumonia / ventilator- associated pneumonia | Q2 2013 | N/A | 2017 |
| 2018 |
Zinforo# | extended spectrum cephalosporin with affinity to penicillin-binding proteins | pneumonia / skin infections | N/A | Launched | N/A | Filed | |
Neuroscience | |||||||
Movantik/Moventig5# | oral peripherally- acting mu-opioid receptor antagonist | opioid-induced constipation | Approved | Filed6 | |||
# Partnered product.
¶ Registrational Phase II / III study.
++ Filing is the responsibility of the partner.
1 Brilinta in the US; Brilique in rest of world.
2 Farxiga in the US; Forxiga in rest of world.
3 Regulatory approval no longer being sought in China. This market will be served by RDEA3170.
4 No current plan to launch CAZ AVI in Japan.
5 Movantik in the US; Moventig in EU.
6 Positive opinion received.
7 Positive opinion announced on 24 October 2014.
Phases I and II
NMEs and significant additional indications
Compound | Mechanism | Area Under Investigation | Phase | Date Commenced Phase | Estimated Filing | |||
US | EU | Japan | China | |||||
Cardiovascular and Metabolism | ||||||||
tenapanor (AZD1722)# | NHE3 inhibitor | ESRD-Pi / CKD with T2DM1 | II | Q1 2013 | ||||
AZD4901 | hormone modulator | polycystic ovarian syndrome | II | Q2 2013 | ||||
AZD1979 | melanin- concentrating hormone (MCH) receptor | obesity | I | Q2 2014 | ||||
MEDI6012 | LCAT | ACS | I | Q1 2012 | ||||
MEDI8111 | Rh-factor II | trauma / bleeding | I | Q1 2014 | ||||
Oncology | ||||||||
AZD1775# | WEE-1 inhibitor | ovarian cancer | II | Q4 2012 | ||||
AZD2014 | mTOR serine / threonine kinase inhibitor | solid tumours | II | Q1 2013 | ||||
AZD4547 | FGFR tyrosine kinase inhibitor | solid tumours | II | Q4 2011 | ||||
MEDI-551# | anti-CD19 MAb | CLL / DLBCL | II | Q1 2012 | ||||
MEDI-573# | anti-IGF MAb | metastatic breast cancer | II | Q2 2012 | ||||
Lynparza (olaparib) | PARP inhibitor | prostate cancer | II | Q3 2014 | ||||
selumetinib# | MEK inhibitor | 2nd line KRAS- NSCLC | II | Q1 2013 | ||||
AZD5363# | AKT kinase inhibitor | breast cancer | II | Q1 2014 | ||||
MEDI4736# | anti-PD-L1 MAb | solid tumours | II | Q3 2014 | ||||
moxetumomab pasudotox# | anti-CD22 recombinant immunotoxin | pALL | II | Q3 2014 | ||||
volitinib# | MET tyrosine kinase inhibitor | papillary renal cell carcinoma | II | Q2 2014 | ||||
AZD5312# | androgen receptor inhibitor | solid tumours | I | Q2 2014 | ||||
AZD6738 | ATR serine / threonine kinase inhibitor | solid tumours | I | Q4 2013 | ||||
AZD8186 | PI3 kinase beta inhibitor | solid tumours | I | Q2 2013 | ||||
AZD9150# | STAT3 inhibitor | haematological malignancies | I | Q1 2012 | ||||
AZD9291 + (MEDI4736# or selumetinib# or volitinib#) | EGFR tyrosine kinase inhibitor + (anti-PD-L1 or MEK inhibitor or MET tyrosine kinase inhibitor) | advanced EGFRm NSCLC | I | Q3 2014 | ||||
Phases I and II (continued)
Compound | Mechanism | Area Under Investigation | Phase | Date Commenced Phase | Estimated Filing | |||
US | EU | Japan | China | |||||
Oncology (continued) | ||||||||
MEDI4736# after (AZD9291 or Iressa or (selumetinib# +docetaxel) or tremelimumab) TATTON | anti-PD-L1 MAb + (EGFR tyrosine kinase inhibitor or MEK inhibitor or anti- CTLA-4 MAb) | NSCLC | I | Q3 2014 | ||||
MEDI-565# | anti-CEA BiTE MAb | solid tumours | I | Q1 2011 | ||||
MEDI0639# | anti-DLL-4 MAb | solid tumours | I | Q2 2012 | ||||
MEDI0680 | anti-PD-1 MAb | solid tumours | I | Q4 2013 | ||||
MEDI3617# | anti-ANG-2 MAb | solid tumours | I | Q4 2010 | ||||
MEDI4736# | anti-PD-L1 MAb | various cancers | I | Q3 2014 | ||||
MEDI4736# + MEDI0680 | anti-PD-L1 MAb + anti-PD- 1 MAb | solid tumours | I | Q2 2014 | ||||
MEDI4736# + MEDI6469 | anti-PD-L1 MAb + murine OX40 agonist | solid tumours | I | Q3 2014 | ||||
MEDI4736# + dabrafenib + trametinib2 | anti-PD-L1 MAb + BRAF inhibitor + MEK inhibitor | melanoma | I | Q1 2014 | ||||
MEDI4736# + Iressa | anti-PD-L1 MAb + EGFR tyrosine kinase inhibitor | NSCLC | I | Q2 2014 | ||||
MEDI4736# + tremelimumab | anti-PD-L1 MAb + anti- CTLA-4 MAb | solid tumors | I | Q4 2013 | ||||
MEDI-551# + rituximab3 | anti-CD19 MAb + anti-CD20 MAb | haematological malignancies | I | Q2 2014 | ||||
MEDI6383 | OX40 agonist | solid tumours | I | Q3 2014 | ||||
MEDI6469# | murine OX40 agonist | solid tumours | I | Q1 2006 | ||||
Respiratory, Inflammation and Autoimmunity | ||||||||
AZD2115# | MABA | COPD | II | Q2 2012 | ||||
AZD9412# | inhaled interferon β | asthma / COPD | II | Q1 2010 | ||||
anifrolumab# | anti-IFN- alphaR MAb | SLE | II | Q1 2012 | ||||
brodalumab# | anti-IL-17R MAb | asthma | II | Q2 2013 | ||||
mavrilimumab# | anti-GM-CSFR MAb | rheumatoid arthritis | II | Q1 2010 | ||||
MEDI2070# | anti-IL-23 MAb | Crohn's disease | II | Q1 2013 | ||||
MEDI7183# | anti-a4b7 MAb | Crohn's disease / ulcerative colitis | II | Q4 2012 | ||||
MEDI9929# | anti-TSLP MAb | asthma | II | Q2 2014 | ||||
PT010 | LAMA / LABA / ICS | COPD | II | Q2 2014 | ||||
RDEA3170 | selective uric acid reabsorption inhibitor (SURI) | chronic management of hyperuricaemia in patients with gout | II | Q3 2013 | ||||
sifalimumab# | anti-IFN-alpha MAb | SLE | II | Q3 2008 | ||||
tralokinumab | anti-IL-13 MAb | IPF | II | Q4 2012 | ||||
Phases I and II (continued)
Compound | Mechanism | Area Under Investigation | Phase | Date Commenced Phase | Estimated Filing | |||
US | EU | Japan | China | |||||
Respiratory, Inflammation and Autoimmunity (continued) | ||||||||
AZD1419# | TLR9 agonist | asthma | I | Q3 2013 | ||||
AZD7594 | inhaled SGRM | asthma / COPD | I | Q3 20124 | ||||
AZD7624 | inhaled P38 inhibitor | COPD | I | Q1 2013 | ||||
MEDI-551# | anti-CD19 MAb | multiple sclerosis | I | Q3 2012 | ||||
MEDI4920 | anti-CD40L- Tn3 fusion protein | primary Sjögren's syndrome | I | Q2 2014 | ||||
MEDI5872# | anti-B7RP1 MAb | SLE | I | Q4 2008 | ||||
Infection | ||||||||
AZD5847 | oxazolidinone anti-bacterial inhibitor | tuberculosis | II | Q4 2012 | ||||
CXL# | beta lactamase inhibitor / cephalosporin | MRSA | II | Q4 2010 | ||||
ATM AVI | monobactam / beta lactamase inhibitor | targeted serious bacterial infections | I | Q4 2012 | ||||
AZD0914 | GyrAR | serious bacterial infections | I | Q4 2013 | ||||
MEDI-550 | pandemic influenza virus vaccine | pandemic influenza prophylaxis | I | Q2 2006 | ||||
MEDI-559 | paediatric RSV vaccine | RSV prophylaxis | I | Q4 2008 | ||||
MEDI4893 | MAb binding to S. aureus toxin | hospital-acquired pneumonia / serious S. aureus infection | I | Q1 2013 | ||||
MEDI3902 | anti-Psl/PcrV | pseudomonas | I | Q3 2014 | ||||
MEDI7510 | RSV sF+GLA- SE | prevention of RSV disease in older adults | I | Q2 2014 | ||||
MEDI8897# | anti-RSV MAb- YTE | passive RSV prophylaxis | I | Q2 2014 | ||||
Neuroscience | ||||||||
AZD3241 | myeloperoxidase inhibitor | multiple system atrophy5 | II | Q2 2012 | ||||
AZD5213 | histamine-3 receptor antagonist | Tourette's syndrome / neuropathic pain | II | Q4 2013 | ||||
AZD3293# | beta-secretase inhibitor | Alzheimer's disease | I | Q4 2012 | ||||
AZD6423 | NMDA antagonist | suicidal ideation | I | Q3 2013 | ||||
MEDI1814 | anti-amyloid beta MAb | Alzheimer's disease | I | Q2 2014 | ||||
# Partnered product.
1 Fluid retention indication for tenapanor terminated in Q2.
2 MedImmune-sponsored study in collaboration with GSK.
3 MedImmune-sponsored study in collaboration with Genentech.
4 Original programme terminated in 2013. Programme now reinitiated.
5 Multiple system atrophy is now the lead indication for this molecule.
Line Extensions
Compound | Mechanism | Area Under Investigation | Date Commenced Phase | Estimated Filing | |||
US | EU | Japan | China | ||||
Cardiovascular and Metabolism | |||||||
Brilinta / Brilique1 EUCLID | ADP receptor antagonist | outcomes study in patients with peripheral artery disease | Q4 2012 | 2017 | 2017 | 2017 | 2018 |
Brilinta / Brilique1 PEGASUS- TIMI 54 | ADP receptor antagonist | outcomes study in patients with prior myocardial infarction | Q4 2010 | 2015 | 2015 | 2015 | 2017 |
Brilinta / Brilique1 SOCRATES | ADP receptor antagonist | outcomes study in patients with stroke or TIA | Q1 2014 | 2016 | 2016 | 2016 | 2017 |
Brilinta / Brilique1 THEMIS | ADP receptor antagonist | outcomes study in patients with type 2 diabetes and CAD, but without a previous history of MI or stroke | Q1 2014 | 2017 | 2017 | 2018 | 2018 |
Bydureon Dual Chamber Pen | GLP-1 receptor agonist | type 2 diabetes | Launched | Approved | Filed | ||
Bydureon EXSCEL | GLP-1 receptor agonist | type 2 diabetes outcomes study | Q2 2010 | 2018 | 2018 | 2018 | |
Bydureon weekly suspension | GLP-1 receptor agonist | type 2 diabetes | Q1 2013 | 2015 | 2015 | ||
Farxiga / Forxiga2 DECLARE- TIMI 58 | SGLT-2 inhibitor | type 2 diabetes outcomes study | Q2 2013 | 2020 | 2020 | ||
Kombiglyze XR FDC / Komboglyze FDC3 | DPP-4 inhibitor / metformin FDC | type 2 diabetes | Launched | Launched | Filed | ||
Onglyza SAVOR- TIMI 53 | DPP-4 inhibitor | type 2 diabetes outcomes study | Q2 2010 | Filed | Launched | 2015 | |
saxagliptin / dapagliflozin FDC | DPP-4 inhibitor / SGLT-2 inhibitor FDC | type 2 diabetes | Q2 2012 | 2015 | 2015 | ||
Xigduo XR FDC / Xigduo FDC4 | SGLT-2 inhibitor / metformin FDC | type 2 diabetes | Filed | Approved6 | |||
Oncology | |||||||
Caprelsa | VEGFR / EGFR tyrosine kinase inhibitor with RET kinase activity | differentiated thyroid cancer | Q2 2013 | 2016 | 2016 | 2016 | |
Faslodex FALCON | oestrogen receptor antagonist | 1st line hormone receptor +ve advanced breast cancer | Q4 2012 | 2016 | 2016 | 2016 | 2016 |
Respiratory, Inflammation and Autoimmunity | |||||||
Symbicort5 | ICS / LABA | Breath Actuated Inhaler asthma / COPD | |||||
Line Extensions (continued)
Compound | Mechanism | Area Under Investigation | Date Commenced Phase | Estimated Filing | |||
US | EU | Japan | China | ||||
Neuroscience | |||||||
Diprivan# | sedative and anaesthetic | conscious sedation | N/A | Launched | Q4 2014 | Launched | |
Gastrointestinal | |||||||
Entocort | glucocorticoid steroid | Crohn's disease / ulcerative colitis | Launched | Launched | 2015 | N/A | |
linaclotide# | GC-C receptor peptide agonist | irritable bowel syndrome with constipation (IBS-C) | N/A | N/A | N/A | 2015 | |
Nexium | proton pump inhibitor | refractory reflux esophagitis | N/A | N/A | Q4 2014 | N/A | |
Nexium | proton pump inhibitor | stress ulcer prophylaxis | N/A | N/A | N/A | 2017 | |
Nexium | proton pump inhibitor | paediatrics | Launched | Launched | 2016 | TBD | |
# Partnered product.
1 Brilinta in the US; Brilique in rest of world.
2 Farxiga in the US; Forxiga in rest of world.
3 Kombiglyze XR in the US; Komboglyze FDC in the EU.
4 Xigduo XR FDC in the US; Xigduo FDC in the EU.
5 Development of a new BAI device is ongoing.
6 Approval announced on 30 October 2014.
Completed projects
Compound | Mechanism | Area Under Investigation | Date Commenced Phase | Estimated Filing | |||
US | EU | Japan | China | ||||
Nexium | proton pump inhibitor | peptic ulcer bleeding | Launched | Launched | N/A | Launched | |
Terminations (discontinued projects between 1 July and 30 September 2014)1
NME / Line Extension | Compound | Reason for Discontinuation | Area Under Investigation |
NME | AZD1208 | Safety / efficacy | haematological malignancies |
NME | AZD8848# | Safety / efficacy | asthma |
LCM | Iressa IMPRESS | Safety / efficacy | treatment beyond progression |
# Partnered product.
1 tremelimumab+Iressa removed from table Q3 2014. Project is not terminated but is an investigator-sponsored study and, therefore, does not meet the requirement for inclusion in this table.