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.

Browse our pipeline1

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

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.

HIV^ and Infectious Diseases chevron-down

Respiratory chevron-down

Oncology chevron-down

Immuno-inflammation chevron-down

Future pipeline optionality chevron-down

Vaccines chevron-down

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dolutegravir + rilpivirine+

PhaseApproved

MAAS: May17

NDA/BLAA: Nov17

Indication

HIV infections – two drug maintenance regimen

Type

HIV integrase inhibitor + non-nucleoside reverse transcriptase inhibitor (NNRTI)

tafenoquine+

PhaseSubmitted

NDA/BLAS: Nov17

Indication

plasmodium vivax malaria

Type

8-aminoquinoline

Dectova (zanamivir) i.v.†

PhaseSubmitted

MAAS: Nov17

Indication

influenza

Type

neuraminidase inhibitor (i.v.)

dolutegravir + lamivudine

PhaseIII

Indication

HIV infection

Type

HIV integrase strand transfer inhibitor + nucleoside reverse transcriptase inhibitor (NRTI)

fostemsavir

PhaseIII

Indication

HIV infection

Type

HIV attachment inhibitor

cabotegravir

PhaseIII

Indication

HIV pre-exposure prophylaxis

Type

HIV integrase strand transfer inhibitor (long-acting)

cabotegravir +
rilpivirine†

PhaseIII

Indication

HIV infection

Type

HIV integrase strand transfer inhibitor + nonnucleoside reverse transcriptase inhibitor (NNRTI) (long-acting regimen)

gepotidacin (2140944)

PhaseII

Indication

bacterial infections

Type

type 2 topoisomerase inhibitor

32288361

PhaseII

Indication

hepatitis B

Type

HBV antisense oligonucleotide

33894041

PhaseII

Indication

hepatitis B

Type

HBV LICA antisense oligonucleotide

CCI15106†

PhaseI

Indication

viral exacerbations of COPD

Type

viral replication inhibitor (nucleoside)

3640254

PhaseI

Indication

HIV infection

Type

HIV maturation inhibitor

3036656†

PhaseI

Indication

tuberculosis

Type

leucyl t-RNA synthetase inhibitor

mepolizumab

PhaseApproved

NDA/BLAA:Dec17

Indication

eosinophilic granulomatosis with polyangiitis

Type

interleukin 5 (IL5) monoclonal antibody

Trelegy (fluticasone
furoate + vilanterol†
+ umeclidinium)

PhaseApproved

MAAA:Nov17

NDA/BLAA:Sep17

Indication

chronic obstructive pulmonary disease (COPD)

Type

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

mepolizumab

PhaseSubmitted

NDA/BLAS:Nov17

Indication

COPD

Type

interleukin 5 (IL5) monoclonal antibody

fluticasone furoate +
vilanterol† +
umeclidinium

PhaseIII

Indication

asthma

Type

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

mepolizumab

PhaseIII

Indication

hypereosinophilic syndrome

Type

interleukin 5 (IL5) monoclonal antibody

mepolizumab

PhaseIII

Indication

nasal polyposis

Type

interleukin 5 (IL5) monoclonal antibody

nemiralisib

Phase2016 Fourth Quarter (2)

Indication

COPD (acute and chronic)

Type

phosphatidylinositol 3-kinase delta (PI3Kδ) inhibitor

danirixin

Phase2016 Fourth Quarter (2)

Indication

COPD

Type

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

2586881†

Phase2016 Fourth Quarter (2)

Indication

acute lung injury

Type

recombinant human angiotensin converting enzyme 2 (rhACE2)

2862277

Phase2016 Fourth Quarter (2)

Indication

acute lung injury

Type

tumour necrosis factor receptor-1 (TNFR1) domain antibody

2245035

Phase2016 Fourth Quarter (2)

Indication

asthma

Type

toll-like receptor 7 (TLR7) agonist

nemiralisib

Phase2016 Fourth Quarter (2)

Indication

activated PI3K delta syndrome

Type

phosphatidylinositol 3-kinase delta (PI3Kδ) inhibitor

3772847†

Phase2016 Fourth Quarter (2)

Indication

severe asthma

Type

interleukin 33r (IL33r) monoclonal antibody

2586881†

Phase2016 Third Quarter (2)

Indication

pulmonary arterial hypertension

Type

recombinant human angiotensin converting enzyme 2 (rhACE2)

3008348

Phase2016 Third Quarter (2)

Indication

idiopathic pulmonary fibrosis

Type

alpha V beta 6 integrin antagonist

nemiralisib

Phase2016 Third Quarter (2)

Indication

bronchiectasis

Type

phosphatidylinositol 3-kinase delta (PI3Kδ) inhibitor

2292767

Phase2016 Third Quarter (2)

Indication

COPD

Type

phosphatidylinositol 3-kinase delta (PI3Kδ) inhibitor

3511294

Phase2016 Third Quarter (2)

Indication

asthma

Type

interleukin 5 (IL5) long-acting monoclonal antibody

3377794†

PhaseII

Indication

sarcoma, multiple myeloma, non-small cell lung cancer, melanoma and ovarian cancer

Type

NY-ESO-1 autologous engineered TCR-T cells (engineered TCR)

2857916†

PhaseII

Indication

multiple myeloma

Type

B-cell maturation antigen antibody drug conjugate

525762

PhaseI

Indication

solid tumours and haematological malignancies

Type

BET family bromodomain inhibitor

3174998†

PhaseI

Indication

solid tumours and haematological malignancies

Type

OX40 agonist monoclonal antibody

3326595

PhaseI

Indication

cancer

Type

protein arginine methyltransferase 5 (PRMT5) inhibitor

3359609

PhaseI

Indication

cancer

Type

induced T-cell costimulator (ICOS) agonist antibody

1795091

PhaseI

Indication

cancer

Type

toll-like receptor 4 (TLR4) agonist

2636771

PhaseI

Indication

castration resistant prostate cancer

Type

phosphatidylinositol 3-kinase (PI3K) beta inhibitor

Benlysta

PhaseApproved

MAAA: Nov17

NDA/BLAA: Jul17

Indication

systemic lupus erythematosus

Type

B lymphocyte stimulator monoclonal antibody (s.c.)

3196165†

PhaseII

Indication

osteoarthritis

Type

granulocyte macrophage colonystimulating factor monoclonal antibody

3196165†

PhaseII

Indication

rheumatoid arthritis

Type

granulocyte macrophage colonystimulating factor monoclonal antibody

Benlysta + Rituxan

PhaseII

Indication

Sjogren's syndrome

Type

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

  1. ref 1
  2. ref 2