Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as pyroglutamate rongliflozin capsules
pyroglutamate rongliflozin · 2 trials · 2 indications
Plasma concentrations of rongliflizin following the administration of a single dose of rongliflozin, the pharmacokinetic parameters for rongliflozin will be measured in varying degrees of kidney function.
Maximum plasma concentration of study drugs
Maximum plasma concentration of study drugs
Incidence of adverse events
| Arm | Type | Description |
|---|---|---|
| Group A and C (normal kidney function) | ACTIVE_COMPARATOR | Each subject will receive a single dose of rongliflozin on Day 1 |
| Group B (mild renal impairment) | EXPERIMENTAL | Each subject will receive a single dose of rongliflozin on Day 1 |
| Group D (moderate renal impairment) | EXPERIMENTAL | Each subject will receive a single dose of rongliflozin on Day 1 |
| Group A (normal liver function) | EXPERIMENTAL | Each subject will receive a single dose of rongliflozin on Day 1 |
| Group B (mild liver damage) | EXPERIMENTAL | Each subject will receive a single dose of rongliflozin on Day 1 |
| Group C (normal liver function) | EXPERIMENTAL | Each subject will receive a single dose of rongliflozin on Day 1 |
| Group D (moderate liver damage) | EXPERIMENTAL | Each subject will receive a single dose of rongliflozin on Day 1 |
| Name | Type | Description |
|---|---|---|
| pyroglutamate rongliflozin capsules | DRUG | Subjects will receive one 50mg capsule orally (by mouth) on Day 1 |
Inclusion Criteria: * Type 2 diabetes patients. * The subject is willing to take effective contraceptive measures without a pregnancy plan within 4 weeks after signing the informed consent form to taking the test drug. * When screening, 19.0 kg/m2 \< or = body mass index (BMI) \< or = 35.0 kg/m2. *...
Pyroglutamate rongliflozin is an investigational small molecule developed by Sunshine Biopharma Inc. (ticker SBFM) for type 2 diabetes. It is in Phase 1 clinical development and has been studied in capsule form in trials conducted in China.
Pyroglutamate rongliflozin is being developed for the treatment of type 2 diabetes mellitus. It is an investigational therapy in Phase 1 development, and its clinical program has focused on evaluating pharmacokinetics and safety in patients with type 2 diabetes and in subjects with liver or kidney impairment.
Pyroglutamate rongliflozin is developed by Sunshine Biopharma Inc., which trades under the ticker SBFM. The company is the sponsor of the Phase 1 clinical trials evaluating the drug in type 2 diabetes and in subjects with impaired liver or kidney function.
Pyroglutamate rongliflozin is in Phase 1 clinical development. It is investigational and has not been approved for marketing. The completed Phase 1 trials enrolled 32 participants each and evaluated pharmacokinetics and safety in type 2 diabetes patients and in subjects with liver or kidney impairment.
Pyroglutamate rongliflozin has been evaluated in two completed Phase 1 trials. NCT05427682 studied the pharmacokinetics and safety of pyroglutamate rongliflozin capsules in subjects with mild and moderate liver damage. NCT05374343 studied the pharmacokinetics, pharmacodynamics, and safety of rongliflozin in type 2 diabetic subjects with renal impairment. Both enrolled 32 participants in China.
Yes. Pyroglutamate rongliflozin capsules is an alternative name for pyroglutamate rongliflozin, referring to the oral capsule formulation used in its clinical trials. Both names refer to the same investigational small molecule developed by Sunshine Biopharma Inc. for type 2 diabetes.