Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
GBT440 · 5 trials · 7 indications
Maximum observed plasma concentration
Time at which maximum concentration was observed
Area under the concentration-time curve
Terminal elimination half-life
| Arm | Type | Description |
|---|---|---|
| GBT440 Dose 1:Mild hepatic impairment | EXPERIMENTAL | Child Pugh A |
| GBT440 Dose 1:Moderate hep. impairment | EXPERIMENTAL | Child Pugh B |
| GBT440 Dose 1:Severe hepatic impairment | EXPERIMENTAL | Child Pugh C |
| GBT440 Dose 1:Normal hepatic function | EXPERIMENTAL | Healthy subjects |
| Name | Type | Description |
|---|---|---|
| GBT440 | DRUG | Capsules which contain GBT440 drug substance in Swedish orange |
| Placebo | DRUG | Placebo capsules |
Inclusion Criteria: All subjects: * Males or females, 18 to 75 years old * Willing and able to give written informed consent Patients with hepatic impairment: * Mild hepatic impairment (Child-Pugh A \[5-6 points\]) * Moderate hepatic impairment (Child-Pugh B \[7-9 points\]) * Severe hepatic impa...
| 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 |
GBT440 is an investigational small molecule being studied for sickle cell disease, anemia of sickle cell disease, and idiopathic pulmonary fibrosis with hypoxemia. It has also been evaluated in healthy subjects for pharmacokinetic studies. The drug is in clinical development and is not approved by the FDA.
GBT440 is being developed by Pfizer, Inc., which trades on the New York Stock Exchange under the ticker PFE. Pfizer is the sponsor of the clinical trials for this investigational drug.
GBT440 has been studied in Phase 1 and Phase 2 clinical trials. The Phase 2 trial evaluated the drug in patients with idiopathic pulmonary fibrosis and hypoxemia. All five clinical trials for GBT440 have been completed, and the drug remains investigational.
GBT440 has been studied in five completed clinical trials. These include NCT02497924, a study of absorption, metabolism, and excretion in healthy subjects; NCT02567695, a bioavailability study in healthy subjects; NCT02846324, a safety and tolerability study in patients with idiopathic pulmonary fibrosis; and NCT05981365, a drug interaction study in healthy subjects.
GBT440 is also known as voxelotor. One of its clinical trials, NCT05981365, is titled "Voxelotor CYP and Transporter Cocktail Interaction Study," confirming that GBT440 and voxelotor refer to the same drug.