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 | Biological License Application | |
| S | Date of first submission | Phase I | Evaluation of clinical pharmacology, usually conducted in volunteers | |
| A | Date 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 | Date 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 | |
Brand names are trademarks either owned by and/or licensed to GlaxoSmithKline or associated companies, with the exception of Entereg, a trademark of Adolor Corporation in the USA, which is used in certain countries under licence by the Group. For competitive reasons, new projects in pre-clinical development have not been disclosed and some project types may not have been identified. 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 trial. 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. Factors that may affect the Group's operations are described under 'Risk factors' in the ‘Business review’ section of the company's Annual Report for 2007 on Form 20-F filed with the US Securities and Exchange Commission. |
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