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 2019.

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.
*
Registrational in PhII
**
Under review
1
Option-based alliance with Ionis Pharmaceuticals, Inc.
2
Option-based alliance with Immunocore Ltd.
S
First submission
A
First regulatory approval (for MAA, this is the first EU approval letter)
R
Receipt of Complete Response Letter
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.

Oncology

HIV^ and Infectious Diseases

Immuno-inflammation

Respiratory

Other Pharmaceuticals

Vaccines

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Zejula (niraparib)†

PhaseIII

Indication

First line maintenance ovarian cancer and other solid tumours

Type

Poly (ADP-ribose) polymerase (PARP) 1/2 inhibitor

dostarlimab†

PhaseIII

Indication

Ovarian cancer

Type

Anti-Programmed Cell Death protein 1 receptor (PD-1) antibody

dostarlimab†

PhaseII

Indication

Non-small cell lung cancer, MSI-H cancer (incl endometrial)*

Type

Anti-Programmed Cell Death protein 1 receptor (PD-1) antibody

2857916†

PhaseII

Indication

Multiple myeloma*

Type

B-cell maturation antigen antibody drug conjugate

3377794†

PhaseII

Indication

Sarcoma, solid and heme malignancies

Type

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

3359609† 

PhaseII

Indication

Non-small cell lung cancer and solid tumours

Type

Induced T-cell co-stimulator (ICOS) agonist antibody

molibresib  (525762)

PhaseII

Indication

ER+ breast cancer, other solid tumours and haematological malignancies

Type

BET family bromodomain inhibitor

M7824†

PhaseII

Indication

Non-small cell lung cancer

Type

Transforming growth factor beta (TGFβ) trap and immune checkpoint (PD-1) inhibitor bispecific

TSR-022†

PhaseII

Indication

Non-small cell lung cancer

Type

Anti-T-cell immunoglobulin and mucin domain-3 (TIM-3) antibody

3174998†

PhaseII

Indication

Solid tumours and haematological malignancies

Type

OX40 agonist monoclonal antibody

3326595†

PhaseI/II

Indication

Solid tumours, heme malignancies

Type

Protein arginine methyltransferase 5 (PRMT5) inhibitor

1795091

PhaseI

Indication

Cancer

Type

Toll-like receptor 4 (TLR4) agonist

2636771

PhaseI

Indication

Cancer

Type

Phosphatidylinositol 3-kinase (PI3K) beta inhibitor

3368715†

PhaseI

Indication

Cancer

Type

Protein arginine methyltransferase 1 (PRMT1) inhibitor

3145095

PhaseI

Indication

Pancreatic cancer and selected solid tumors

Type

RIP1 kinase inhibitor

35371422

PhaseI

Indication

Cancer

Type

NY-ESO-1-targeting bispecific

TSR-033†

PhaseI

Indication

Cancer

Type

Anti-lymphocyte activation gene-3 (LAG-3) antibody

Dectova  (zanamivir) i.v.†

PhaseSubmitted

MAAS: Nov17

Indication

Influenza

Type

Neuraminidase inhibitor (i.v.)

dolutegravir + lamivudine

PhaseSubmitted

MAAS: Sept18

NDA/BLAS: Oct18

Indication

HIV infection

Type

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

fostemsavir

PhaseIII

Indication

HIV infection

Type

HIV attachment inhibitor

cabotegravir + rilpivirine†

PhaseIII

Indication

HIV infection

Type

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

cabotegravir

PhaseIII

Indication

HIV pre-exposure prophylaxis

Type

HIV integrase strand transfer inhibitor (long-acting)

gepotidacin

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

3640254

PhaseII

Indication

HIV infection

Type

HIV maturation inhibitor

3036656†

PhaseI

Indication

Tuberculosis

Type

Leucyl t-RNA synthetase inhibitor

3810109†

PhaseI

Indication

HIV infection

Type

HIV broadly neutralizing antibody

Benlysta + Rituxan†

PhaseIII

Indication

Systemic lupus erythematosus

Type

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

Benlysta + Rituxan†

PhaseII

Indication

Sjogren’s syndrome

Type

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

3196165†

PhaseII

Indication

Rheumatoid arthritis

Type

Granulocyte macrophage colonystimulating factor monoclonal antibody

2982772

PhaseII

Indication

Psoriasis**, rheumatoid arthritis, ulcerative colitis

Type

Receptor-interacting protein 1 (RIP1) kinase inhibitor

2330811

PhaseII

Indication

Systemic sclerosis

Type

Oncostatin M (OSM) monoclonal antibody

2831781†

PhaseI

Indication

Ulcerative colitis

Type

Lymphocyte activation gene 3 (LAG3) protein monoclonal antibody

2983559

PhaseI

Indication

Inflammatory bowel diseases**

Type

Receptor-interacting protein 2 (RIP2) kinase inhibitor

3358699†

PhaseI

Indication

Rheumatoid arthritis

Type

BET targeted inhibitor

3858279†

PhaseI

Indication

Pain in osteoarthritis

Type

CCL17 inhibitor

mepolizumab

PhaseComplete response letter

NDA/BLAR: Sep18

Indication

COPD

Type

Interleukin 5 (IL5) monoclonal antibody

mepolizumab

PhaseIII

Indication

hypereosinophilic syndrome and nasal polyposis

Type

Interleukin 5 (IL5) monoclonal antibody

fluticasone furoate + vilanterol† + umeclidinium

PhaseIII

Indication

Asthma

Type

Glucocorticoid agonist + long-acting beta2 agonist + muscarinic a cetylcholine antagonist

2586881†

PhaseII

Indication

Acute lung injury** and pulmonary arterial hypertension

Type

Recombinant human angiotensin converting enzyme 2 (rhACE2)

2862277

PhaseII

Indication

Acute lung injury

Type

Tumour necrosis factor receptor-1 (TNFR1) domain antibody

3772847†

PhaseII

Indication

Asthma

Type

Interleukin 33r (IL33r) monoclonal antibody

2881078

PhaseII

Indication

COPD muscle weakness

Type

Selective androgen receptor modulator

nemiralisib

PhaseI

Indication

Activated PI3K delta syndrome

Type

Phosphatidylinositol 3-kinase delta (PI3Kδ) inhibitor

2292767

PhaseI

Indication

Respiratory diseases**

Type

Phosphatidylinositol 3-kinase delta (PI3Kδ) inhibitor

3511294†

PhaseI

Indication

Asthma

Type

Interleukin 5 (IL5) long-acting monoclonal antibody

Krintafel† (tafenoquine) 

PhaseApproved

NDA/BLA A: Jul18

Indication

Plasmodium vivax malaria

Type

8-aminoquinoline

daprodustat (1278863)

PhaseIII

Indication

Anaemia associated with chronic renal disease

Type

Prolyl hydroxylase inhibitor (oral)

oxytocin (inhaled)†

PhaseII

Indication

Postpartum hemorrhage

Type

Oxytocin

linerixibat (2330672)

PhaseII

Indication

Cholestatic pruritus

Type

Ileal bile acid transporter (IBAT) inhibitor

3439171†

PhaseI

Indication

Muscle repair

Type

Hematopoietic prostaglandin D2 (hPGD2) synthase inhibitor

Shingrix†  (Zoster Vaccine) 

PhaseApproved

MAAA:March 2018

Indication

Herpes Zoster prophylaxis

Type

Recombinant

Shingrix†  (Zoster Vaccine) 

PhaseIII

Indication

Herpes Zoster prophylaxis for immunocompromised

Type

Recombinant

Bexsero

PhaseIII (US)

Indication

Meningococcal B disease prophylaxis in infants

Type

Recombinant

Rotarix

PhaseIII

Indication

Rotavirus prophylaxis

Type

Live attenuated, PCV (Porcine circovirus) free

MMR

PhaseIII (US)

Indication

Measles, mumps, rubella prophylaxis

Type

Live attenuated

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

Menveo Liquid

PhaseII

Indication

Meningococcal A,C,W and Y disease prophylaxis in adolescents

Type

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

RSV†

PhaseI/II

Indication

Respiratory syncytial virus prophylaxis in older adult population

Type

Replication-defective recombinant viral vector

RSV†

PhaseI/II

Indication

Respiratory syncytial virus prophylaxis in maternal population

Type

Replication-defective recombinant viral vector

HIV†

PhaseII

Indication

HIV infection prophylaxis

Type

Recombinant proteins

Flu universal†

PhaseI/II

Indication

Flu disease prophylaxis with broad protection over multiple seasons

Type

Universal inactivated split influenza vaccine