Product pipeline

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.

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 2016.

Key

Key

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.

Compound Type Indication Phase MAA NDA/BLA
HIV^ and Infectious Diseases scroll or swipe to view full table

dolutegravir + rilpivirine+

HIV integrase inhibitor + non-nucleoside reverse transcriptase inhibitor (NNRTI) HIV infections – two drug maintenance regimen III

dolutegravir + lamivudine

HIV integrase inhibitor + nucleoside reverse transcriptase inhibitor (NRTI) HIV infections III

3684934

HIV attachment inhibitor HIV infections III

cabotegravir

HIV integrase inhibitor (long-acting parenteral formulation) HIV pre-exposure prophylaxis III

cabotegravir + rilpivirine+

HIV integrase inhibitor + non-nucleoside reverse transcriptase inhibitor (NNRTI) (long-acting parenteral formulations) HIV infections III

tafenoquine+

8-aminoquinoline plasmodium vivax malaria III

Relenza i.v.+

neuraminidase inhibitor (i.v.) influenza III

gepotidacin (2140944)

type 2 topoisomerase inhibitor bacterial infections II

danirixin i.v.

chemokine (C-X-C Motif) receptor 2 (CXCR2) antagonist influenza* II

2878175+RG101+

nonstructural protein 5B (NS5B) polymerase inhibitor + anti-miR122 antisense oligonucleotide hepatitis C II

3342830

antibacterial cephalosporin bacterial infection I

2838232

HIV maturation inhibitor HIV infections I

32288361

HBV LICA antisense oligonucleotide hepatitis B I

3389404+

HBV LICA antisense oligonucleotide hepatitis B I
Respiratory scroll or swipe to view full table

fluticasone furoate + vilanterol+ + umeclidinium

glucocorticoid agonist + long-acting beta2 agonist + muscarinic acetylcholine antagonist chronic obstructive pulmonary disease (COPD) Submitted S: Dec 16 S: Nov 16

mepolizumab

interleukin 5 (IL5) monoclonal antibody COPD* III

fluticasone furoate + vilanterol+ umeclidinium

glucocorticoid agonist + long-acting beta2 agonist + muscarinic acetylcholine antagonist asthma III

961081+

muscarinic acetylcholine antagonist, beta2 agonist (MABA) COPD II

961081+ fluticasone furoate

muscarinic acetylcholine antagonist, beta2 agonist (MABA) + glucocorticoid agonist COPD II

danirixin

chemokine (C-X-C Motif) receptor 2 (CXCR2) antagonist (oral) COPD* II

2269557

phosphatidylinositol 3-kinase delta (PI3K ) inhibitor COPD (acute and chronic) II

2586881+

recombinant human angiotensin converting enzyme 2 (rhACE2) acute lung injury II

2862277

tumour necrosis factor receptor-1 (TNFR1) domain antibody acute lung injury II

mepolizumab 2

interleukin 5 (IL5) monoclonal antibody hypereosinophilic syndrome* II

mepolizumab

interleukin 5 (IL5) monoclonal antibody nasal polyposis* II

2245035

toll-like receptor 7 (TLR7) agonist asthma II

sirukumab+

interleukin 6 (IL6) human monoclonal antibody severe asthma* II

2269557

phosphatidylinositol 3-kinase delta (PI3Kδ) inhibitor activated PI3K delta syndrome I

3772847+

interleukin 33r (IL33r) monoclonal antibody severe asthma I

2586881+

recombinant human angiotensin converting enzyme 2 (rhACE2) pulmonary arterial hypertension I

3008348

alpha V beta 6 integrin antagonist idiopathic pulmonary fibrosis I

2269557

phosphatidylinositol 3-kinase delta (PI3Kδ) inhibitor bronchietasis I
Oncology scroll or swipe to view full table

33777942

NY-ESO-1 autologous engineered TCR-T cells (engineered TCR) sarcoma, multiple myeloma, non-small cell lung cancer, melanoma and ovarian cancer II

tarextumab3

notch 2/3 monoclonal antibody small cell lung cancer II

3174998+

OX40 agonist monoclonal antibody solid tumours and haematological malignancies I

2816126

enhancer of zeste homologue2 (EZH2) inhibitor solid tumours and haematological malignancies I

525762

BET family bromodomain inhibitor solid tumours and haematological malignancies I

2879552

lysine-specific demethylase 1 (LSD1) inhibitor acute myeloid leukemia and small cell lung cancer I

2857916+

beta cell maturation antigen antibody drug conjugate multiple myeloma I

3326595

protein arginine methyltransferase 5 (PRMT5) inhibitor cancer I

3359609

induced T-cell costimulator (ICOS) agonist antibody cancer I

1795091

toll-like receptor 4 (TLR4) agonist cancer I

2636771

phosphatidylinositol 3-kinase (PI3K) beta inhibitor castration resistant prostate cancer I
Immuno-inflammation scroll or swipe to view full table

sirukumab+

interleukin 6 (IL6) human monoclonal antibody rheumatoid arthritis* Submitted S: Sep16 S: Sep16

Benlysta

B lymphocyte stimulator monoclonal antibody (s.c.) systemic lupus erythematosus* Submitted S: Sep16 S: Sep16

sirukumab+

interleukin 6 (IL6) human monoclonal antibody giant cell arteritis* III

3196165+

granulocyte macrophage colony-stimulating factor monoclonal antibody osteoarthritis II

3196165+

granulocyte macrophage colonystimulating factor monoclonal antibody rheumatoid arthritis II

Benlysta + Rituxan

B lymphocyte stimulator monoclonal antibody (s.c.) + cluster of differentiation 20 (CD20) monoclonal antibody (i.v.) Sjogren's syndrome II

2982772

receptor-interacting protein 1 (RIP1) kinase inhibitor psoriasis, rheumatoid arthritis and ulcerative colitis II

3117391+

macrophage targeted histone deacetylase inhibitor rheumatoid arthritis II

2330811

oncostatin M (OSM) monoclonal antibody systemic sclerosis I

2618960

interleukin 7 (IL7) receptor monoclonal antibody Sjogren's syndrome I

2646264

spleen tyrosine kinase (Syk) inhibitor (topical) chronic urticaria I

2831781+

lymphocyte activation gene 3 (LAG3) protein monoclonal antibody autoimmune disease I

3050002+

chemokine (C-C motif) ligand 20 chemokine (C-C motif) ligand 20 psoriatic arthritis I

3179106

rearranged during transfection (RET) kinase inhibitor inflammatory disorders of the bowel I
Rare diseases scroll or swipe to view full table

Strimvelis+

ex-vivo stem cell gene therapy adenosine deaminase severe combined immune deficiency (ADA-SCID) Approved A: May16

2998728+

transthyretin (TTR) production inhibitor transthyretin-mediated amyloidosis III

2696274+

ex-vivo stem cell gene therapy metachromatic leukodystrophy III

2696275+

ex-vivo stem cell gene therapy Wiscott-Aldrich syndrome III

mepolizumab

interleukin 5 (IL5) monoclonal antibody eosinophilic granulomatosis with polyangiitis* III

2398852+ + 2315698+

serum amyloid P component (SAP) monoclonal antibody + SAP depleter (CPHPC) amyloidosis II

26962774

ex-vivo stem cell gene therapy beta-thalassemia II

2256098

focal adhesion kinase inhibitor pulmonary arterial hypertension (PAH) I S: May15
Vaccines scroll or swipe to view full table

Shingrix(Zoster Vaccine)

recombinant Herpes Zoster prophylaxis Submitted S: Nov16 S: Oct 16

MMR

live attenuated measles, mumps, rubella prophylaxis III (US) N/A

Ebola+

recombinant viral vector Ebola haemorrhagic fever prophylaxis II

Group B Streptococcus

conjugated Group B streptococcus prophylaxis (maternal immunisation) II

S. pneumoniae next generation+

recombinant – conjugated Streptococcus pneumoniae disease prophylaxis II

COPD+

recombinant reduction of the frequency of COPD exacerbations associated with non-typeable Haemophilus influenzae and Moraxella catarrhalis II

Hepatitis C+

recombinant viral vector hepatitis C virus prophylaxis II

Malaria next generation+

recombinant malaria prophylaxis (Plasmodium falciparum) II

Men ABCWY

recombinant – conjugated meningococcal A,B,C,W and Y disease prophylaxis in adolescents II

Shigella+

conjugated and outer membrane Shigella diarrhea prophylaxis II

TuberculosisTuberculosis+

recombinant tuberculosis prophylaxis II

RSV

recombinant respiratory syncytial virus prophylaxis (maternal immunisation) II

RSV

replication-defective recombinant viral vector respiratory syncytial virus prophylaxis II

HIV+

recombinant proteins HIV infection prophylaxis II
Other pharmaceuticals: Metabolic scroll or swipe to view full table

retosiban

oxytocin antagonist spontaneous pre-term labour III

daprodustat (1278863)

prolyl hydroxylase inhibitor (oral) anaemia associated with chronic renal disease III

2330672

ileal bile acid transport (IBAT) inhibitor cholestatic pruritus II

2798745

transient receptor potential cation channel V4 (TRPV4) antagonist heart failure II

1070806

interleukin 18 (IL18) neutralisation mAb delayed graft function after renal transplantation II

oxytocin (inhaled)+

cluster of differentiation 3 (CD3) monoclonal antibody new onset type 1 diabetes II

daprodustat (1278863)

prolyl hydroxylase inhibitor (topical) wound healing I

3008356

diglyceride acyltransferase (DGAT) 1 inhibitor nonalcoholic steatohepatitis I

2881078

selective androgen receptor modulator muscle wasting I

oxytocin (inhaled)+

oxytocin postpartum hemorrhage I
Other pharmaceuticals: Dermatology scroll or swipe to view full table

mepolizumab

interleukin 5 (IL5) monoclonal antibody severe atopic dermatitis* I

2894512+

non-steroidal anti-inflammatory (topical) atopic dermatitis II

2894512+

non-steroidal anti-inflammatory (topical) psoriasis II

2981278

ROR gamma inverse agonist (topical) psoriasis II
Other pharmaceuticals: Neurosciences scroll or swipe to view full table

IONIS-GSK4-L1

ocular target LICA antisense oligonucleotide geographic atrophy age-related macular disease I

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