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GSK2126458 · 2 trials · 2 indications
Pharmacodynamic will be measured by inhibition of pAKT/AKT in platelet-rich plasma and BAL cells, as well as inhibition of glucose uptake as measured by thoracic\[18F\]-FDG-PET/CT
GSK2126458 PK parameters in blood in order to define the blood and pulmonary PK/PD relationship for GSK2126458 in IPF subjects
GSK2126458 PK parameters in blood in order to define the blood and pulmonary PK/PD relationship for GSK2126458 in IPF subjects
GSK2126458 PK parameters in blood in order to define the blood and pulmonary PK/PD relationship for GSK2126458 in IPF subjects
GSK2126458 concentration in BALF in order to define the pulmonary PK/PD relationship for GSK2126458 in IPF subjects
| Arm | Type | Description |
|---|---|---|
| Cohort 1-GSK2126458 | EXPERIMENTAL | Subjects will be randomized in 3:1 ratio to receive either GSK2126458 (0.25 mg twice daily \[bid\]) or placebo for approximately 8 days (7 to 10 days dosing) |
| Cohort 1-Placebo | PLACEBO_COMPARATOR | Subjects will be randomized in 3:1 ratio to receive either GSK2126458 bid or matching placebo for approximately 8 days (7 to 10 days dosing) |
| Cohort 2-GSK2126458 | EXPERIMENTAL | Subjects will be randomized in 3:1 ratio to receive either GSK2126458 bid or placebo for approximately 8 days (7 to 10 days dosing). GSK2126458 dose will be decided from Cohort 1 and which could be escalated or deescalated or repeated from Cohort 1 dosing. |
| Cohort 2-Placebo | PLACEBO_COMPARATOR | Subjects will be randomized in 3:1 ratio to receive either GSK2126458 bid or matching placebo for approximately 8 days (7 to 10 days dosing). |
| Cohort 3- GSK2126458 | EXPERIMENTAL | Subjects will be randomized in 3:1 ratio to receive either GSK2126458 bid or placebo for approximately 8 days (7 to 10 days dosing). GSK2126458 dose will be decided from Cohort 2 and which could be escalated or deescalated or repeated from Cohort 2 dosing. |
| Cohort 3-Placebo | PLACEBO_COMPARATOR | Subjects will be randomized in 3:1 ratio to receive either GSK2126458 bid or matching placebo for approximately 8 days (7 to 10 days dosing). |
| Cohort 4- GSK2126458 | EXPERIMENTAL | Subjects will be randomized in 3:1 ratio to receive either GSK2126458 bid or placebo for approximately 8 days (7 to 10 days dosing). GSK2126458 dose will be decided from Cohort 3 and which could be escalated or deescalated or repeated from Cohort 3 dosing. |
| Cohort 4- Placebo | PLACEBO_COMPARATOR | Subjects will be randomized in 3:1 ratio to receive either GSK2126458 bid or matching placebo for approximately 8 days (7 to 10 days dosing). |
| Cohort 5- GSK2126458 | EXPERIMENTAL | Subjects will be randomized in 3:1 ratio to receive either GSK2126458 bid or placebo for approximately 8 days (7 to 10 days dosing). GSK2126458 dose will be decided from Cohort 4 and which could be escalated or deescalated or repeated from Cohort 4 dosing. |
| Cohort 5- Placebo | PLACEBO_COMPARATOR | Subjects will be randomized in 3:1 ratio to receive either GSK2126458 bid or matching placebo for approximately 8 days (7 to 10 days dosing). |
| Cohort 6- GSK2126458 | EXPERIMENTAL | Subjects will be randomized in 3:1 ratio to receive either GSK2126458 bid or placebo for approximately 8 days (7 to 10 days dosing). GSK2126458 dose will be decided from Cohort 4 and which could be escalated or deescalated or repeated from Cohort 5 dosing. |
| Cohort 6- Placebo | PLACEBO_COMPARATOR | Subjects will be randomized in 3:1 ratio to receive either GSK2126458 bid or matching placebo for approximately 8 days (7 to 10 days dosing). |
| GSK2126458 | EXPERIMENTAL | GSK2126458 will be dosed continuously (every day) for the duration a 28 day cycle. The 28 day cycles will continue until the subjects withdraw from the study. |
| Name | Type | Description |
|---|---|---|
| GSK2126458 | DRUG | GSK2126458 will be available as film coated tablet of dose strength 0.25 mg and 0.5 mg |
| Placebo | DRUG | Matching placebo will be available |
Inclusion Criteria: * Diagnosis of IPF as determined by a responsible and experienced chest physician and based on established criteria defined by the American Thoracic Society/European Respiratory Society: American Thoracic Society/European Respiratory Society International Multidisciplinary Conse...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Bristol-Myers Squibb Company | BMY | 2 | PHASE3 | BMS-986278 |
| United Therapeutics Corporation | UTHR | 2 | PHASE3 | Treprostinil |
| AbbVie, Inc. | ABBV | 2 | PHASE2 | ABBV-142 |
| PureTech Health PLC Sponsored ADR | PRTC | 2 | PHASE3 | Deupirfenidone, Pirfenidone |
| Syndax Pharmaceuticals Inc | SNDX | 1 | PHASE2 | Axatilimab |
| Contineum Therapeutics, Inc. Class A | CTNM | 1 | PHASE2 | PIPE-791 Dose A, PIPE-791 Dose B |
| Rein Therapeutics, Inc | RNTX | 1 | PHASE2 | LTI-03 |
| Sunshine Biopharma Incorporated | SBFM | 2 | PHASE3 | HEC585, Pirfenidone |
| Cumberland Pharmaceuticals Inc. | CPIX | 1 | PHASE2 | Ifetroban |
| Avalyn Pharma Inc | AVLN | 3 | PHASE2 | AP01 |
GSK2126458 is an investigational small molecule being studied for Idiopathic Pulmonary Fibrosis and Solid Tumours. It is in Phase 1 clinical development and is not approved by the FDA. The drug is being developed by GSK plc.
GSK2126458 is being developed by GSK plc, a pharmaceutical company listed on the stock exchange under the ticker GSK. The drug is currently in Phase 1 clinical trials for Idiopathic Pulmonary Fibrosis and Solid Tumours.
GSK2126458 is in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA. Clinical trials for the drug have been completed, including studies in Solid Tumours and Idiopathic Pulmonary Fibrosis.
GSK2126458 has been studied in two completed Phase 1 clinical trials. NCT00972686 was a dose-escalation study in Solid Tumours with 79 participants. NCT01725139 was a proof of mechanism study in Idiopathic Pulmonary Fibrosis with 17 participants.
GSK2126458 is also known by the name omipalisib. It is an investigational small molecule being developed by GSK plc for Idiopathic Pulmonary Fibrosis and Solid Tumours. The drug is currently in Phase 1 clinical development.