Product pipelineThis page provides an outline of our drug development portfolio. The content of the drug development portfolio will change over time as new compounds progress from discovery to development and from development to the market. Owing to the nature of the drug development process, many of these compounds, especially those in early stages of investigation, may be terminated as they progress through development. For competitive reasons, new projects in pre-clinical development have not been disclosed and some project types may not have been identified. |
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In-license or other alliance relationship with third party | BLA MAA |
Biological License Application Marketing Authorisation Approval |
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| S | Month of first submission | Phase I | Evaluation of clinical pharmacology, usually conducted in volunteers | |
| A | Month of first regulatory approval (for MAA, this is the first EU approval letter) | Phase II | Determination of dose and initial evaluation of efficacy, conducted in a small number of patients | |
| AL/CR | Month approvable or complete response letter received - indicates that ultimately approval can be given subject to resolution of outstanding queries | Phase III | Large comparative study (compound versus placebo and/or established treatment) in patients to establish clinical benefit and safety | |
PO TA |
Month of EU Positive Opinion FDA Tentative Approval |
(V) (I) |
Vaccine Cancer Immunotherapeutic |
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Estimated submission dates are only disclosed where they are within 12 months of the date of the chart. This date represents the most likely year of submission where it is considered that there is a reasonably high probability of successfully meeting the date assuming the clinical data meets the expected end-points of the clinical trials. Brand names appearing in italics are trademarks either owned by and/or licensed to GlaxoSmithKline or associated companies, with the exception of Doxil, a trademark of the Alza Corporation in the US. Cautionary statement
regarding forward-looking information 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 2009. |
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