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SB681323 · 3 trials · 3 indications
Participants were asked to rate their overall pain intensity for the last 24 hours, daily before retiring to bed. This constituted the Daily Pain Score. The 11 point pain intensity numerical rating scale ranged from 0 to 10, where 0 represents "No pain" and 10 represents "Maximum pain imaginable". It was used for the subjective assessment of the pain. The score ranged from 0 to 10, where 0 represented absence of symptoms and higher score indicated more severe symptoms. The average daily pain over Week 1 (Day 7) was calculated as the mean of days 2 to 6 inclusive and for week 2 (Day 14), days 8 to 13 inclusive. Participants were instructed to record their daily pain score on a dairy card and calculations of average weekly pain scores were performed on the basis of diary cards review.
Levels of ex-vivo LPS induced TNFα in whole blood at 1, 2, 6 and 24 hrs post-dose
| Arm | Type | Description |
|---|---|---|
| SB681323 | EXPERIMENTAL | Patients with pain associated with peripheral nerve injury and/or compression will be recruited for this study. |
| Placebo | EXPERIMENTAL | Patients with pain associated with peripheral nerve injury and/or compression will be recruited for this study. |
| Randomised, double-blind, five-way crossover | EXPERIMENTAL | A randomised, double-blind, double-dummy, placebo-controlled, five-way crossover study to assess the effects of single oral doses of SB-681323 (7.5 mg and 25 mg) and prednisolone (10 mg and 30 mg) on biomarkers in induced sputum and blood in COPD patients. |
| Name | Type | Description |
|---|---|---|
| SB681323 | DRUG | 15 milligrams (mg)/day |
| Placebo | DRUG | - |
| Prednisolone | DRUG | 5 mg size DB AA capsule shell (Swedish orange) with a powder backfill (lactose Anhydrous) |
Inclusion criteria: * A subject will be eligible for inclusion in this study only if all of the following criteria apply: Male or female subjects 18-80 years of age * To be eligible, females patients must have a negative pregnancy test (i.e. serum beta hCG test) and be of: 1. non-childbearing ...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Eli Lilly and Company | LLY | 1 | PHASE2 | LY3016859 ISA, LY3556050 ISA, LY3526318 ISA, LY3857210 ISA |
| Dogwood Therapeutics Inc | DWTX | 1 | PHASE2 | Halneuron |
| Sangamo Therapeutics, Inc. | SGMO | 1 | PHASE1 | ST-503 |
| Boston Scientific Corporation | BSX | 1 | N/A | Undisclosed |
| Collegium Pharmaceutical, Inc. | COLL | 1 | N/A | Undisclosed |
SB-681323 is an investigational small molecule being studied for several conditions, including acute lung injury, rheumatoid arthritis, coronary heart disease, chronic obstructive pulmonary disease (COPD), and neuropathic pain. It is in Phase 2 clinical development for these indications.
SB-681323 is a small molecule being developed for inflammatory and pain conditions. Its specific molecular target has not been disclosed in available information, so its exact mechanism of action is not described here.
SB-681323 is being developed by GSK plc, a global biopharma company listed on the stock exchange under the ticker GSK. GSK is conducting clinical trials to evaluate the drug's safety and efficacy.
SB-681323 is in Phase 2 clinical development. It has completed four clinical trials, including Phase 2 studies in COPD, coronary heart disease, and acute lung injury, as well as a Phase 1 study in COPD. It is not yet approved by regulatory authorities.
SB-681323 has completed four clinical trials: NCT00144859 in COPD patients, NCT00291902 in coronary heart disease patients undergoing percutaneous intervention, NCT00380133 in COPD patients, and NCT00996840 in patients at risk of acute lung injury or ARDS. All trials are completed.
Yes, SB-681323 is also referred to as SB681323 in some clinical trial records. Both names refer to the same investigational drug being developed by GSK plc for inflammatory and pain-related conditions.