ASTRAZENECA DEVELOPMENT PIPELINE
AS AT 31 MARCH 2014
NMEs
Phase III / Registration
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
Filed
Launched
Cardiovascular and Metabolism
arterial thrombosis
Brilinta / Brilique1 ADP receptor
antagonist
Epanova#
omega-3 free fatty hypertriglyceridaemia
acids
Farxiga / Forxiga2 SGLT-2 inhibitor diabetes
Myalept
Launched Launched
Filed
Launched Launched Approved
leptin analogue
lipodystrophy
Approved
2015
VEGFR / EGFR
tyrosine kinase
inhibitor with RET
kinase activity
anti-CD22
recombinant
immunotoxin
PARP inhibitor
medullary thyroid
cancer
Launched Launched
Filed
N/A
Oncology
Caprelsa
moxetumomab
#
pasudotox
olaparib
olaparib SOLO-1 PARP inhibitor
olaparib SOLO-2 PARP inhibitor
olaparib GOLD
PARP inhibitor
olaparib
OlympiAD
selumetinib#
(ARRY-142886)
SELECT-1
selumetinib#
(ARRY-142886)
ASTRA
selumetinib#
(ARRY-142886)
SUMIT
PARP inhibitor
MEK inhibitor
hairy cell leukaemia
BRCAm PSR ovarian
cancer
1st line BRCAm
ovarian cancer
BRCAm PSR ovarian
cancer
2nd line gastric
cancer
metastatic breast
cancer
2nd line KRAS+
NSCLC
Q2 2013
Q3 2014
Filed
2018
2018
Filed3
Filed
Q3 2013
2017
2017
2017
2017
Q3 2013
2016
2016
2016
2016
2017
2018
Q3 2013
Q2 20144
2016
2016
Q4 2013
2017
2017
MEK inhibitor
differentiated thyroid
5
cancer
Q3 2013
2017
2017
MEK inhibitor
uveal melanoma5
Q1 20146
2015
2015
2017
Phase III / Registration (continued)
Compound
Mechanism
Area Under
Investigation
Date
Commenced
Phase
US
EU
Estimated Filing
Japan
China
Respiratory, Inflammation and Autoimmunity
benralizumab#
brodalumab#
AMAGINE-1,2,3
brodalumab#
AMVISION-1,2
lesinurad
PT003 GFF
PT001 GP
anti-IL-5R MAb
anti-IL-17R MAb
severe asthma
psoriasis
Q4 2013
Q3 2012
2016
++
2016
++
anti-IL-17R MAb
psoriatic arthritis
Q1 2014
++
++
selective uric acid
reabsorption
inhibitor (SURI)
LAMA / LABA
LAMA
chronic treatment
of patients with
gout
COPD
COPD
Q4 2011
Q4 2014
Q4 2014
Q2 2013
Q2 2013
2015
2015
2016
2016
cephalosporin /
beta lactamase
inhibitor
cephalosporin /
beta lactamase
inhibitor
serious infections
Q1 2012
N/A
Q4 2014
2015
2016
hospital-acquired
pneumonia /
ventilatorassociated
pneumonia
extended spectrum pneumonia / skin
cephalosporin with infections
affinity to penicillinbinding proteins
Q2 2013
N/A
2017
2017
2018
N/A
Launched
N/A
Q2 2014
Filed
Filed
2017
Infection
CAZ AVI#
(CAZ104)
RECLAIM
CAZ AVI#
(CAZ104)
REPROVE
Zinforo#
Neuroscience
naloxegol#
(NKTR-118)
#
++
1
2
3
4
5
6
oral peripherallyopioid-induced
acting mu-opioid
constipation
receptor antagonist
Partnered product.
Filing is the responsibility of the partner.
Brilinta in the US; Brilique in rest of world.
Farxiga in the US; Forxiga in rest of world.
FDA accepted submission April 2014.
First patient randomised April 2014.
These indications previously included under the broad Phase II project listing.
First patient expected to dose early Q2 2014.
NMEs
Phases I and II
Compound
Mechanism
Area Under
Investigation
Date
Phase Commenced
Phase
Estimated Filing
US
EU
Japan
China
2018
NA
NA
2016
Cardiovascular and Metabolism
AZD1722#
NHE3 inhibitor
AZD4901
hormone
modulator
hypoxiainducible factor
inhibitor
LCAT
Rh-factor II
roxadustat#
(FG-4592)
MEDI6012
MEDI8111
ESRD-Pi CKD with
T2DM / ESRD-fluid
retention
polycystic ovarian
syndrome
anaemia in CKD /
ESRD
II
Q1 2013
II
Q2 2013
II1
arterial thrombosis
trauma / bleeding
I
I
Q1 2012
Q1 2014
ovarian cancer
solid tumours
II
II
Q4 2012
Q1 2013
solid tumours
II
Q4 2011
haematological
malignancies
anti-IGF MAb
metastatic breast
cancer
anti-PD-L1 MAb NSCLC
MEK inhibitor
2nd line KRASNSCLC
II
Q1 2012
II
Q2 2012
II
II
Q1 2014
Q1 2013
anti-CTLA4 MAb
AKT kinase
inhibitor
PIM kinase
inhibitor
ATR serine /
threonine kinase
inhibitor
PI3 kinase beta
inhibitor
STAT3 inhibitor
mesothelioma
breast cancer
II
II
Q2 2013
Q1 2014
haematological
malignancies
CLL / head & neck
I
Q1 2012
I
Q4 2013
solid tumours
I
Q2 2013
haematological
malignancies
solid tumours
I
Q1 2012
I
Q1 2013
solid tumours
I
Q1 2011
solid tumours
solid tumours
I
I
Q2 2012
Q4 2013
solid tumours
solid tumors
I
I
Q4 2010
Q4 2013
melanoma
I
Q1 2014
solid tumours
I
Q1 2006
Oncology
AZD1775#
AZD2014
AZD4547
MEDI-551#
MEDI-573#
MEDI4736#
selumetinib#
(ARRY142886)
tremelimumab
AZD5363#
AZD1208
AZD6738
AZD8186
AZD9150#
AZD9291
MEDI-565#
MEDI0639#
MEDI0680
(AMP-514)
MEDI3617#
MEDI4736# +
tremelimumab
MEDI4736# +
dabrafenib +
trametinib2
MEDI6469#
WEE-1 inhibitor
mTOR serine /
threonine kinase
inhibitor
FGFR tyrosine
kinase inhibitor
anti-CD19 MAb
EGFR tyrosine
kinase inhibitor
anti-CEA BiTE
MAb
anti-DLL-4 MAb
anti-PD-1 MAb
anti-ANG-2 MAb
anti-PD-L1 MAb
+ anti-CTLA4
MAb
anti-PD-L1 MAb
+ BRAF inhibitor
+ MEK inhibitor
murine antiOX40 MAb
NMEs
Phases I and II (continued)
Compound
Mechanism
Area Under
Investigation
Date
Phase Commenced
Phase
Oncology (continued)
moxetumomab anti-CD22
pasudotox#
recombinant
immunotoxin
volitinib#
MET tyrosine
(AZD6094)
kinase inhibitor
pALL
I
Q3 2008
solid tumours
I
Q1 2012
COPD
asthma
II
II
Q2 2012
Q4 2010
SLE
II
Q1 2012
COPD
asthma
rheumatoid arthritis
II
II
II
Q4 2010
Q2 2013
Q1 2010
Crohn’s disease
Crohn’s disease /
ulcerative colitis
COPD / HS
chronic
management of
hyperuricaemia in
patients with gout
SLE
II
II
Q1 2013
Q4 2012
II
II
Q4 2011
Q3 2013
II
Q3 2008
asthma / IPF
asthma
COPD
II
I
I
Q1 2008
Q3 2013
Q3 2013
COPD
I
Q1 2013
asthma
I
Q2 2012
multiple sclerosis
SLE
asthma
COPD
I
I
I
I
Q3 2012
Q4 2008
Q4 2008
Q4 2013
tuberculosis
II
Q4 2012
MRSA
II
Q4 2010
targeted serious
bacterial infections
I
Q4 2012
serious bacterial
infections
pandemic influenza
prophylaxis
I
Q4 2013
I
Q2 2006
Respiratory, Inflammation and Autoimmunity
AZD2115#
AZD5069
anifrolumab#
(MEDI-546)
benralizumab#
brodalumab#
mavrilimumab#
MEDI2070#
MEDI7183#
MEDI8968#
RDEA3170
sifalimumab#
(MEDI-545)
tralokinumab
AZD1419
AZD4721
AZD7624
AZD8848#
MEDI-551#
MEDI5872#
MEDI9929#
PT010
MABA
CXCR2
antagonist
anti-IFN-alphaR
MAb
anti-IL-5R MAb
anti-IL-17R MAb
anti-GM-CSFR
MAb
anti-IL-23 MAb
anti-a4b7 MAb
anti-IL-1R MAb
selective uric
acid
reabsorption
inhibitor (SURI)
anti-IFN-alpha
MAb
anti-IL-13 MAb
TLR9 antagonist
CXCR2
antagonist
inhaled P38
inhibitor
inhaled TLR7
antagonist
anti-CD19 MAb
anti-B7RP1 MAb
anti-TSLP MAb
LAMA / LABA /
ICS
Infection
AZD5847
CXL#
ATM AVI
AZD0914
MEDI-550
oxazolidinone
anti-bacterial
inhibitor
beta lactamase
inhibitor /
cephalosporin
monobactam /
beta lactamase
inhibitor
GyrAR
pandemic
influenza virus
vaccine
Estimated Filing
US
EU
Japan
China
NMEs
Phases I and II (continued)
Compound
Mechanism
Area Under
Investigation
Date
Phase Commenced
Phase
Estimated Filing
US
EU
Japan
Infection (continued)
MEDI-559
(PRVV)
MEDI4893
MEDI92873
RSV prophylaxis
paediatric RSV
vaccine
MAb binding to S. hospital-acquired
aureus toxin
pneumonia /
serious S. aureus
infection
H7N9 vaccine
avian influenza
I
Q4 2008
I
Q1 2013
I
Q4 2013
myeloperoxidase
inhibitor
histamine-3
receptor
antagonist
beta-secretase
inhibitor
NMDA antagonist
II
Q2 2012
II
Q4 2013
I
Q4 2012
I
Q3 2013
Neuroscience
AZD3241
AZD5213
AZD3293#
AZD6423
#
1
2
3
Parkinson’s
disease
Tourette’s
syndrome /
neuropathic pain
Alzheimer’s
disease
suicidal ideation
Partnered product.
In-licensed asset in late-development but the Phase III AstraZeneca programme has yet to randomise its first patient.
MedImmune-sponsored study in collaboration with GSK.
Vaccine in development through a CRADA with NIH.
China
Line Extensions
Compound
Mechanism
Area Under
Investigation
Date
Commenced
Phase
US
EU
Japan
China
Q4 2012
2016
2016
2016
2017
Q4 2010
2015
2015
2015
2017
Q1 2014
2016
2016
2016
2017
Q1 2014
2017
2017
2018
2018
Approved
Filed
Q2 2014
2018
Estimated Filing
Cardiovascular and Metabolism
Brilinta /
Brilique1
EUCLID
ADP receptor
antagonist
Brilinta /
1
Brilique
PEGASUSTIMI 54
Brilinta /
1
Brilique
SOCRATES
Brilinta /
1
Brilique
THEMIS
ADP receptor
antagonist
Bydureon Dual
Chamber Pen
Bydureon
EXSCEL
Bydureon
weekly
suspension
Farxiga /
2
Forxiga
DECLARETIMI 58
Kombiglyze XR
FDC /
Komboglyze
FDC3
Onglyza
SAVOR-TIMI 53
saxagliptin /
dapagliflozin
FDC
Xigduo XR FDC
5
/ Xigduo FDC
GLP-1 receptor
agonist
GLP-1 receptor
agonist
GLP-1 receptor
agonist
ADP receptor
antagonist
ADP receptor
antagonist
outcomes study in
patients with
peripheral artery
disease
outcomes study in
patients with prior
myocardial
infarction
outcomes study in
patients with
stroke or TIA
outcomes study in
patients with Type
2 diabetes and
CAD, but without a
previous history of
MI or stroke
diabetes
outcomes study
Q2 2010
2018
2018
diabetes
Q1 2013
2015
2015
SGLT-2 inhibitor
outcomes study
Q2 2013
2020
2020
DPP-4 inhibitor /
metformin FDC
diabetes
DPP-4 inhibitor
outcomes study
DPP-4 inhibitor /
SGLT-2 inhibitor
FDC
SGLT-2 inhibitor /
metformin FDC
diabetes
VEGFR / EGFR
tyrosine kinase
inhibitor with RET
kinase activity
oestrogen receptor
antagonist
differentiated
thyroid cancer
EGFR tyrosine
kinase inhibitor
Launched Launched
Filed
Q2 2010
Q1 20144
Filed
2015
Q2 2012
2015
2015
Filed
Approved6
Q2 2013
2016
2016
2016
1st line advanced
breast cancer
Q4 2012
2016
2016
2016
2016
treatment beyond
progression
Q1 2012
2015
2015
2015
diabetes
Oncology
Caprelsa
Faslodex
FALCON
Iressa
Respiratory, Inflammation and Autoimmunity
Symbicort7
ICS / LABA
Breath Actuated
Inhaler asthma /
COPD
Line Extensions (continued)
Compound
Mechanism
Area Under
Investigation
sedative and
anaesthetic
conscious
sedation
glucocorticoid
steroid
GC-C receptor
peptide agonist
Crohn’s disease /
ulcerative colitis
irritable bowel
syndrome with
constipation
(IBS-C)
peptic ulcer
bleeding
Date
Commenced
Phase
Estimated Filing
US
EU
Japan
China
N/A
Launched
Q4 2014
Launched
2015
N/A
N/A
2015
N/A
Launched
Neuroscience
Diprivan#
Gastrointestinal
Entocort
linaclotide#
Nexium
#
1
2
3
4
5
6
7
proton pump
inhibitor
Partnered product.
Brilinta in the US; Brilique in rest of world.
Farxiga in the US; Forxiga in rest of world.
Kombiglyze XR in the US; Komboglyze FDC in the EU.
Filed and awaiting regulatory acceptance.
Xigduo XR FDC in the US; Xigduo FDC in the EU.
Approval granted in January 2014 but reported as a progression for FY2013.
Development of a new BAI device is ongoing.
Launched Launched
N/A
N/A
Approved Launched
