Our medicines and vaccines in development are classified into three stages: phase I, phase II and phase III. These studies into the safety and efficacy of investigational products provide data to support applications to regulators for approval.
This page provides an outline of the medicines and vaccines in development.
Owing to the nature of drug development, many compounds - especially those in early stages of investigation - may be terminated through the development process. For competitive reasons, new projects in pre-clinical development are not disclosed and some project types may not be identified.
Brand names are trademarks either owned by and/or licensed to GSK or associated companies.
At a glance
3
Significant approvals in 2017 – Shingrix, Trelegy Ellipta and Juluca
The content of our development pipeline will change over time as new compounds progress from discovery to development and from development to the market. This annual pipeline information was updated in March 2018.2
In-licence or other alliance relationship with third party
^
ViiV Healthcare, a global specialist HIV company with GSK, Pfizer, Inc. and Shionogi Limited as shareholders, is responsible for developing and delivering HIV medicines.
*
Also being developed for indications in another therapeutic area
1
Option-based alliance with Ionis Pharmaceuticals
2
Option-based alliance with Adaptimmune Ltd.
3
Option-based alliance with OncoMed Pharmaceuticals
4
Option-based alliance with Telethon and Ospedale San Raffaele
5
Option-based alliance with Valneva
S
Month of first submission
BLA
Biological Licence Application
MAA
Marketing Authorisation Application (Europe)
NDA
New Drug Application (US)
Phase I
Evaluation of clinical pharmacology, usually conducted in volunteers
Phase II
Determination of dose and initial evaluation of efficacy, conducted in a small number of patients
Phase III
Large comparative study (compound versus placebo and/or established treatment) in patients to establish clinical benefit and safety
MAA and NDA/BLA regulatory review milestones shown in the table below are those that have been achieved. Future filing dates are not included in this list.
B lymphocyte stimulator monoclonal antibody (s.c.) + cluster of differentiation 20 (CD20) monoclonal antibody (i.v.)
2982772
PhaseII
Indication
psoriasis
Type
receptor-interacting protein 1 (RIP1) kinase inhibitor
2982772
PhaseII
Indication
rheumatoid arthritis
Type
receptor-interacting protein 1 (RIP1) kinase inhibitor
2330811
PhaseII
Indication
systemic sclerosis
Type
oncostatin M (OSM) monoclonal antibody
2982772
PhaseII
Indication
ulcerative colitis
Type
receptor-interacting protein 1 (RIP1) kinase inhibitor
2831781†
PhaseI
Indication
autoimmune disease
Type
lymphocyte activation gene 3 (LAG3) protein monoclonal antibody
2983559
PhaseI
Indication
inflammatory bowel diseases
Type
receptor-interacting protein 2 (RIP2) kinase inhibitor
3335065
PhaseI
Indication
acute pancreatitis
Type
Kynurenine 3-monooxygenase inhibitor
daprodustat (1278863)
PhaseIII
Indication
anaemia associated with chronic renal disease
Type
prolyl hydroxylase inhibitor (oral)
dezamizumab (2398852)† + 2315698†
PhaseII
Indication
amyloidosis
Type
serum amyloid P component (SAP) monoclonal antibody + SAP depleter (CPHPC)
oxytocin (inhaled)†
PhaseII
Indication
postpartum hemorrhage
Type
oxytocin
tapinarof (2894512)†
PhaseII
Indication
atopic dermatitis
Type
non-steroidal anti-inflammatory (topical)
tapinarof (2894512)†
PhaseII
Indication
psoriasis
Type
non-steroidal anti-inflammatory (topical)
2881078
PhaseI
Indication
muscle wasting
Type
selective androgen receptor modulator
Shingrix† (Zoster Vaccine)
PhaseApproved (US) Submitted (EU)
MAAS: Nov16
NDA/BLAA: Oct17
Indication
Herpes Zoster prophylaxis
Type
recombinant
Rotavirus
PhaseIII
Indication
Rotavirus prophylaxis
Type
live attenuated, PCV (Porcine circovirus) free
MMR
PhaseIII (US)
MAAN/A
Indication
measles, mumps, rubella prophylaxis
Type
live attenuated
Ebola†
PhaseII
Indication
Ebola haemorrhagic fever prophylaxis
Type
recombinant viral vector
S. pneumoniae next generation†
PhaseII
Indication
Streptococcus pneumoniae disease prophylaxis
Type
recombinant – conjugated
COPD
PhaseII
Indication
reduction of the frequency of moderate and severe acute exacerbations in COPD patients by targeting non-typeable Haemophilus influenzae and Moraxella catarrhalis
Type
recombinant
Hepatitis C†
PhaseII
Indication
hepatitis C virus prophylaxis: prevention of establishment of chronic infection
Type
heterologous recombinant viral vectors
Malaria next generation†
PhaseII
Indication
malaria prophylaxis (Plasmodium falciparum)
Type
recombinant
Men ABCWY
PhaseII
Indication
meningococcal A,B,C,W and Y disease prophylaxis in adolescents
Type
recombinant – conjugated
Shigella†
PhaseII
Indication
Shigella diarrhea prophylaxis
Type
conjugated and outer membrane
Tuberculosis†
PhaseII
Indication
tuberculosis prophylaxis
Type
recombinant
RSV
PhaseII
Indication
respiratory syncytial virus prophylaxis in paediatric population
Type
replication-defective recombinant viral vector
Flu universal†
PhaseI/II
Indication
Flu infection prophylaxis with broad protection over multiple seasons
Type
universal inactivated influenza vaccine
HIV†
PhaseII
Indication
HIV infection prophylaxis
Type
recombinant proteins
REFERENCE
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