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.
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 published in March 2012. An update will be available in March 2013.
Owing to the nature of the 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 appearing in italics are trademarks either owned by and/or licensed to GlaxoSmithKline or associated companies.
View the product pipeline by :-
| Compound/ vaccine | Type | Indication | Phase |
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| Antigen-specific cancer immunotherapeutic (ASCI) | |||||||||
| PRAME immunotherapeutic† | recombinant | resectable non-small cell lung cancer | Phase I | ||||||
| WT1 immunnotherapeutic | recombinant | treatment of breast cancer | Phase I | ||||||
| MAGE-A3 immunotherapeutic† | recombinant | treatment of bladder cancer | Phase II | ||||||
| MAGE-A3 immunotherapeutic† | recombinant | treatment of non-small cell lung cancer | Phase III | ||||||
| MAGE-A3 immunotherapeutic† | recombinant | treatment of melanoma | Phase III | ||||||
| Biopharmaceuticals | |||||||||
| 1223249 | neurite outgrowth inhibitor (NOGO-A) monoclonal antibody | amyotrophic lateral sclerosis & multiple sclerosis | Phase I | ||||||
| 1995057 | tumour necrosis factor receptor-1 (TNFR1) domain antibody | acute lung injury | Phase I | ||||||
| 2374697 | glucagon like peptide-1 (GLP 1) agonist with half-life improving domain antibody | obesity | Phase I | ||||||
| 2661380† | immunomodulator | solid tumours | Phase I | ||||||
| 3052230† | fibroblast growth factor ligand trap | cancer | Phase I | ||||||
| otelixizumab† | CD3 monoclonal antibody (s.c. & i.v.) | rheumatoid arthritis | Phase I | ||||||
| 1070806 | IL18 monoclonal antibody | type 2 diabetes | Phase II | ||||||
| 249320 | myelin-associated glycoprotein monoclonal antibody | stroke | Phase II | ||||||
| 2586881† | recombinant human angiotensin converting enzyme 2 | acute lung injury | Phase II | ||||||
| 933776 | beta amyloid monoclonal antibody | geographic retinal atrophy | Phase II | ||||||
| belimumab | B lymphocyte stimulator monoclonal antibody (i.v.) | idiopathic membranous nephropathy | Phase II | ||||||
| belimumab | B lymphocyte stimulator monoclonal antibody (i.v.) | myaesthenia gravis | Phase II | ||||||
| mapatumumab | tumor necrosis factor-related apoptosis-inducing ligand receptor 1 (TRAIL-R1) monoclonal antibody | advanced hepatocellular carcinoma | Phase II | ||||||
| ofatumumab† | CD20 human monoclonal antibody (s.c.) | multiple sclerosis | Phase II | ||||||
| ozanezumab (1223249) | neurite outgrowth inhibitor (NOGO-A) monoclonal antibody | amyotrophic lateral sclerosis | Phase II | ||||||
| Arzerra (ofatumumab)† | CD20 human monoclonal antibody | follicular lymphoma (refractory & relapsed patients) | Phase III | ||||||
| Arzerra (ofatumumab)† | CD20 human monoclonal antibody | chronic lymphocytic leukaemia, first line therapy & use in relapsed patients | Phase III | ||||||
| Arzerra (ofatumumab)† | CD20 human monoclonal antibody | diffuse large B cell lymphoma (relapsed patients) | Phase III | ||||||
| Benlysta (belimumab) | B lymphocyte stimulator monoclonal antibody (s.c.) | systemic lupus erythematosus | Phase III | ||||||
| Benlysta (belimumab) | B lymphocyte stimulator monoclonal antibody (i.v.) | vasculitis | Phase III | ||||||
| mepolizumab | IL5 monoclonal antibody | severe asthma | Phase III | ||||||
| sirukumab† | IL6 human monoclonal antibody (s.c.) | rheumatoid arthritis | Phase III | ||||||
| albiglutide | GLP 1 agonist | type 2 diabetes | Submitted | S: Jan 13 | |||||
| raxibacumab | protective antigen inhibitor | inhalation anthrax | Approved | A: Dec 12 | |||||
| Cardiovascular & metabolic | |||||||||
| 1614235† + 2330672 | sodium dependent glucose transport (SGLT1) inhibitor + ileal bile acid transport (iBAT inhibitor) | type 2 diabetes | Phase I | ||||||
| 2849466 | selective androgen receptor modulator | heart failure | Phase I | ||||||
| 2890457 | endogenous gut peptide simulator | obesity | Phase I | ||||||
| 1278863 | prolyl hydroxylase inhibitor | anaemia associated with chronic renal disease | Phase II | ||||||
| camicinal (962040) | motilin receptor agonist | delayed gastric emptying | Phase II | ||||||
| losmapimod | p38 kinase inhibitor | acute coronary syndrome (also COPD) | Phase II | ||||||
| retosiban | oxytocin antagonist | threatened pre-term labour | Phase II | ||||||
| ronacaleret† | calcium receptor antagonist | allogeneic haematopoietic stem cell mobilisation | Phase II | ||||||
| darapladib | Lp-PLA2 inhibitor | atherosclerosis (also diabetic macular oedema) | Phase III | ||||||
| HIV (ViiV Healthcare) | |||||||||
| S/GSK1265744 | HIV integrase inhibitor (long-acting parenteral formulation) | HIV infections | Phase II | ||||||
| dolutegravir + abacavir sulphate+ lamivudine | HIV integrase inhibitor + reverse transcriptaseinhibitors (fixed dose combination) | HIV infections | Phase III | ||||||
| dolutegravir | HIV integrase inhibitor | HIV infections | Submitted | S: Dec12 | S: Dec12 | ||||
| Immuno-inflammation | |||||||||
| 2245840 | SIRT1 activator | psoriasis | Phase II | ||||||
| 2586184† | Janus kinase 1 (JAK1) inhibitor | systemic lupus erythematosus + psoriasis | Phase II | ||||||
| 2941266† | CCR1 chemokine receptor antagonist | rheumatoid arthritis | Phase II | ||||||
| vercirnon (1605786†) | CCR9 chemokine receptor antagonist | Crohn’s disease | Phase III | ||||||
| Infectious diseases | |||||||||
| 2140944 | type 2 topoisomerase inhibitor | bacterial infections | Phase I | ||||||
| 2696266† | cephalosporin | bacterial infections | Phase I | ||||||
| 1322322 | polypeptide deformylase inhibitor | bacterial infections | Phase II | ||||||
| 2336805† | hepatitis C virus inhibitor | hepatitis C | Phase II | ||||||
| tafenoquine† | 8-aminoquinoline | Plasmodium vivax malaria | Phase II | ||||||
| Relenza i.v. (zanamivir)† | neuraminidase inhibitor (i.v.) | influenza | Phase III | ||||||
| Neurosciences | |||||||||
| 2647544 | Lp-PLA2 inhibitor | Alzheimer's disease | Phase I | ||||||
| 356278 | phoshodiesterase 4 inhibitor | Huntington’s disease | Phase I | ||||||
| 239512 | H3 receptor antagonist | multiple sclerosis | Phase II | ||||||
| 742457 | 5HT6 antagonist | dementia | Phase II | ||||||
| firategrast† | dual alpha 4 integrin antagonist (VLA4) | multiple sclerosis | Phase II | ||||||
| rilapladib | Lp-PLA2 inhibitor | Alzheimer’s disease | Phase II | ||||||
| Patrome (IPX066)† | dopamine precursor + DOPA decarboxylase inhibitor | Parkinson’s disease | Phase III | N/A | |||||
| Oncology | |||||||||
| 2110183 | AKT protein kinase inhibitor | multiple myeloma | Phase I | ||||||
| 2256098 | focal adhesion kinase inhibitor | cancer | Phase I | ||||||
| 2636771 | phosphatidylinositol 3-kinase (PI3K) inhibitor | cancer | Phase I | ||||||
| 525762 | bromodomain inhibitor | NUT gene midline carcinoma | Phase I | ||||||
| trametinib† + 2141795 | MEK1/2 inhibitor + AKT protein kinase inhibitor | cancer | Phase I | ||||||
| 2110183 | AKT protein kinase inhibitor | Langerhan cell histiocytosis | Phase II | ||||||
| 2110183 | AKT protein kinase inhibitor | ovarian cancer | Phase II | ||||||
| Revolade/Promacta (eltrombopag)† | thrombopoietin receptor agonist | acute myeloid leukaemia | Phase II | ||||||
| Revolade/Promacta (eltrombopag)† | Type: thrombopoietin receptor agonist | myelodysplastic syndromes | Phase II | ||||||
| Revolade/Promacta (eltrombopag)† | thrombopoietin receptor agonist | aplastic anaemia | Phase II | ||||||
| dabrafenib | BRaf protein kinase inhibitor | non-small cell lung cancer | Phase II | ||||||
| foretinib† | mesenchymal-epithelial transition factor (C-met) kinase inhibitor | cancer | Phase II | ||||||
| trametinib† | MEK1/2 inhibitor | KRAS mutant non-small cell lung cancer, second line therapy | Phase II | ||||||
| trametinib† + dabrafenib | MEK1/2 inhibitor + BRaf protein kinase inhibitor | colorectal cancer | Phase II | ||||||
| Tyverb/Tykerb (lapatinib) | Her2 and EGFR dual kinase inhibitor | head & neck squamous cell carcinoma (resectable disease) | Phase III | ||||||
| Tyverb/Tykerb (lapatinib) | human epidermal growth factor receptor-2 (Her2) and epidermal growth factor receptor (EGFR) dual kinase inhibitor | breast cancer, adjuvant therapy | Phase III | ||||||
| Tyverb/Tykerb (lapatinib) | Her2 and EGFR dual kinase inhibitor | gastric cancer | Phase III | ||||||
| Votrient (pazopanib) | multi-kinase angiogenesis inhibitor | ovarian cancer, maintenance therapy | Phase III | ||||||
| Votrient (pazopanib) | multi-kinase angiogenesis inhibitor | renal cell cancer, adjuvant therapy | Phase III | ||||||
| trametinib† + dabrafenib | MEK1/2 inhibitor + BRaf protein kinase inhibitor | metastatic melanoma, adjuvent therapy | Phase III | ||||||
| Tyverb/Tykerb (lapatinib) | Her2 and EGFR dual kinase inhibitor | metastatic breast cancer, in combination with trastuzumab | Submitted | S: Feb12 | |||||
| dabrafenib | BRaf protein kinase inhibitor | metastatic melanoma | Submitted | S: July12 | S: July12 | ||||
| trametinib + dabrafenib | MEK 1/2 inhibitor + BRaf protein kinase inhibitor | metastatic melanoma | Submitted | S: Feb13 | |||||
| trametinib† | MEK1/2 inhibitor | metastatic melanoma | Submitted | S: Feb13 | S: Aug12 | ||||
| Revolade/Promacta(eltrombopag)† | thrombopoietin receptor agonist | hepatitis C induced thrombocytopaenia | Approved | S: May12 | A: Nov12 | ||||
| Votrient (pazopanib) | multi-kinase angiogenesis inhibitor | sarcoma | Approved | A: Aug12 | A: Apr12 | ||||
| Ophthalmology | |||||||||
| darapladib | Lp-PLA2 inhibitor | diabetic macular oedema (also atherosclerosis) | Phase II | ||||||
| Other vaccines | |||||||||
| HIV† | recombinant | HIV disease prophylaxis | Phase I | ||||||
| NTHi† | recombinant | non-typeable Haemophilus influenzae prophylaxis | Phase I | ||||||
| Staphylococcus aureus | recombinant - conjugated | Staphylococcus aureus prophylaxis | Phase I | ||||||
| HIV† | recombinant | HIV disease immunotherapy | Phase II | ||||||
| Tuberculosis† | recombinant | tuberculosis prophylaxis | Phase II | ||||||
| Zoster† | recombinant | Herpes Zoster prophylaxis | Phase III | ||||||
| Flu (pre-) pandemic | H5N1 inactivated split - monovalent (Quebec) | pre-pandemic & pandemic influenza prophylaxis | Submitted | N/A | S: Feb12 | ||||
| Flu vaccine | inactivated split - quadrivalent | seasonal influenza prophylaxis | Approved | S: Mar12 | A: Dec12 | ||||
| Paediatric vaccines | |||||||||
| S. pneumoniae paediatric next generation† | recombinant - conjugated | Streptococcus pneumoniae disease prophylaxis | Phase II | ||||||
| MMR | live attenuated | measles, mumps, rubella prophylaxis | Phase III | A: Nov97 | |||||
| Mosquirix (Malaria RTS,S) | recombinant | malaria prophylaxis (Plasmodium falciparum) | Phase III | N/A | |||||
| MenHibrix (Hib-MenCY-TT) | conjugated | Neisseria meningitis groups C & Y & Haemophilus influenzae type b disease prophylaxis | Approved | N/A | A: June12 | ||||
| Nimenrix (MenACWY-TT) | conjugated | Neisseria meningitis groups A, C, W & Y disease prophylaxis | Approved | A: Apr12 | |||||
| Rare diseases | |||||||||
| migalastat HCI† + ERT | pharmacological chaperone + enzyme replacement therapy (ERT) | Fabry disease | Phase II | ||||||
| 2696273† | ex-vivo stem cell gene therapy | adenosine deaminase severe combined immune deficiency(ADA-SCID) | Phase III | ||||||
| drisapersen (2402968)† | antisense oligonucleotide | Duchenne muscular dystrophy | Phase III | ||||||
| migalastat HCl† | pharmacological chaperone | Fabry disease | Phase III | ||||||
| Respiratory | |||||||||
| 1325756 | CXCR2 chemokine receptor antagonist | COPD | Phase I | ||||||
| 2256294 | soluble epoxide hydrolase inhibitor | COPD | Phase I | ||||||
| 2269557 | phosphoinositide 3 kinase inhibitor | asthma + COPD | Phase I | ||||||
| 2339345 | sodium channel blocker | cough | Phase I | ||||||
| fluticasone furoate (685698) + vilanterol† + umeclidinium (573719) | glucocorticoid agonist + lonh-acting beta2 agonist + muscarinic acetylcholine antagonist | COPD | Phase I | ||||||
| 2190915† | 5-lipoxygenase-activating protein (FLAP) inhibitor | asthma | Phase II | ||||||
| 2245035 | toll-like receptor 7 agonist | asthma | Phase II | ||||||
| 961081† | muscarinic antagonist, beta2 agonist | COPD | Phase II | ||||||
| dilmapimod | p38 kinase inhibitor (i.v.) | acute lung injury & acute respiratory distress syndrome | Phase II | ||||||
| fluticasone furoate (685698) + umeclidinium (573719) | glucocorticoid agonist + muscarinic acetylcholine antagonist | asthma | Phase II | ||||||
| losmapimod | p38 kinase inhibitor (oral) | COPD (also acute coronary syndrome) | Phase II | ||||||
| Relvar/Breo (vilanterol† + fluticasone furoate) | long-acting beta2 agonist + glucocorticoid agonist | COPD - mortality claim | Phase III | ||||||
| fluticasone furoate (685698) | glucocorticoid agonist | asthma | Phase III | ||||||
| umeclidinium (573719) | muscarinic acetylcholine antagonist | COPD | Phase III | ||||||
| vilanterol† | long-acting beta2 agonist | COPD | Phase III | ||||||
| Anoro (umeclidinium + vilanterol†) | muscarinic acetylcholine antagonist + long-acting beta2 agonist | COPD | Submitted | S: Jan13 | S: Dec12 | ||||
| Relvar/Breo (vilanterol† + fluticasone furoate) | long-acting beta2 agonist + glucocorticoid agonist | COPD | Submitted | S: June12 | S: July12 | ||||
| Relvar/Breo (vilanterol† + fluticasone furoate) | long-acting beta2 agonist + glucocorticoid agonist | asthma | Submitted | S: June12 | |||||
| Stiefel (late-stage assets only) | |||||||||
| 2894512 | non-steroidal anti-inflammatory | atopic dermatitis | Phase II | ||||||
| alitretinoin | retinoic acid receptor modulator | chronic hand eczema | Phase III | N/A | |||||
| Duac low dose | clindamycin/benzoyl peroxide gel | acne vulgaris | Submitted | S: Nov11 | S:Nov10 | ||||
| Fabior (tazarotene foam) | retinoid foam | acne vulgaris | Approved | N/A | A: May12 | ||||
| Sorilux | vitamin D3 analog | scalp psoriasis | Approved | N/A | A: Sep12 | ||||
Cautionary statement regarding forward-looking information
Under the safe harbor provisions of the US Private Securities Litigation Reform Act of 1995, the company cautions investors that any forward-looking statements or projections made by the company, including those made in this document, are subject to risks and uncertainties that may cause actual results to differ materially from those projected.
Continued development of commercially viable new products is critical to the Group’s ability to replace sales of older products that decline upon expiration of exclusive rights, and to increase overall sales. Developing new products is a costly, lengthy and uncertain process. A new product candidate can fail at any stage of the process, and one or more late-stage product candidates could fail to receive regulatory approval.
New product candidates may appear promising in development but, after significant investments, fail to reach the market or have only limited commercial success as a result of efficacy or safety concerns, inability to obtain necessary regulatory approvals, difficulty or excessive costs to manufacture or infringement of patents or other intellectual property rights of others or inability to differentiate the product adequately from those with which it competes.
Other factors that may affect the Group’s operations are described under ‘Risk Factors’ in the Operating and Financial Review and Prospects in the company’s Annual Report on Form 20-F for 2011.