Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
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 being developed for the treatment of Type 2 Diabetes Mellitus. It is currently in Phase 1 clinical development and has not been approved by regulatory authorities.
Pyroglutamate rongliflozin is being developed by Sunshine Biopharma Inc., a company listed on the stock exchange under the ticker SBFM. The drug is in Phase 1 clinical development for Type 2 Diabetes.
Pyroglutamate rongliflozin is in Phase 1 clinical development. It is an investigational drug and has not been approved for any use. Two Phase 1 studies have been completed, with a total of 32 participants enrolled in each trial.
Pyroglutamate rongliflozin has been studied in two completed Phase 1 trials. NCT05374343 evaluated pharmacokinetics, pharmacodynamics, and safety in Type 2 diabetic subjects with renal impairment. NCT05427682 evaluated pharmacokinetics and safety in subjects with mild and moderate liver damage.
Pyroglutamate rongliflozin is a form of rongliflozin, as indicated by the clinical trial title for NCT05374343, which refers to rongliflozin. The drug is being developed for Type 2 Diabetes and is currently in Phase 1 trials.