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SB-656933 · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| Subjects receiving SB-656933 | EXPERIMENTAL | Eligible subjects will be randomized to receive once daily doses of 100 milligrams of SB- 656933 for 14 days. |
| Subjects receiving placebo | PLACEBO_COMPARATOR | Eligible subjects will be randomized to receive placebo for 14 days. |
| Name | Type | Description |
|---|---|---|
| SB-656933 | DRUG | SB-656933 will be available as white film coated, round tablet and will be available in strengths of 50 milligrams, administered orally once daily. |
| Placebo | DRUG | A placebo tablet to visually match the SB-656933 tablet will also be supplied, administered orally once daily. |
Inclusion Criteria: * Healthy adult male smokers who are between 18-65 years of age with normal genitourinary anatomy based on physical examination. * The subjects should have a normal colour Doppler epididymal ultrasound (normal blood flow and epididymal morphology) at screening. * The first 10 mL...
SB-656933 is an investigational small molecule being developed for respiratory conditions, specifically chronic obstructive pulmonary disease (COPD) and cystic fibrosis. It has been studied in clinical trials for these indications, though it remains in early-stage development and is not approved for any use.
SB-656933 is being developed by GSK plc, a global pharmaceutical company listed on the stock exchange under the ticker GSK. The company has sponsored clinical trials of this investigational drug for respiratory diseases.
SB-656933 is in Phase 1 clinical development. It has completed two Phase 1 trials and one Phase 2 trial, but it remains investigational and has not received regulatory approval. The drug is not currently in any active clinical trials.
SB-656933 has been studied in three completed trials. NCT00605761 was a single-dose study in 9 cystic fibrosis patients in the United States. NCT00615576 was a repeat-dose study in 13 male healthy volunteer smokers in the United Kingdom. NCT00903201 was a 28-day repeat-dose study in 146 cystic fibrosis patients across multiple countries.
No, SB-656933 is not FDA approved. It is an investigational drug that has completed early-stage clinical trials for cystic fibrosis and chronic obstructive pulmonary disease. The drug is still in clinical development and has not been authorized for commercial use.