Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Morphothiadine Mesilate Capsules, Morphothiadine Mesilate Capsule
GLS4 · 4 trials · 2 indications
The value of serum HBsAg at 48 weeks of treatment was lowered compared with baseline.
The mean value of HBV DNA (unit IU/ml) at different time points in each group was lowered compared with baseline.
To assess the safety and tolerability after dosing.
maximum observed plasma concentration
area under the plasma concentration-time curve (AUC)
To assess the safety and tolerability of therapy.
Time to maximum concentration of study drugs
Terminal half-life of study drugs
| Arm | Type | Description |
|---|---|---|
| Combination group | EXPERIMENTAL | Subjects will receive 96 weeks of GLS4+RTV+ETV. |
| Entecavir monotherapy | ACTIVE_COMPARATOR | Subjects received 96 weeks of entecavir treatment |
| GLS4 120 mg+ RTV 100mg，bid | EXPERIMENTAL | Patients with chronic HBV infection will receive GLS4 120 mg+ Ritonavir Tablet 100 mg twice daily for 48 weeks. |
| GLS4 120 mg+ RTV 100mg，tid | EXPERIMENTAL | Patients with chronic HBV infection will receive GLS4 120 mg+ Ritonavir Tablet 100 mg three times daily for 48 weeks . |
| Part A | EXPERIMENTAL | Subjects will receive GLS4 and RTV on Day 1, TAF on Day 5-14, GLS4 and RTV and TAF on Day15. |
| Part B | EXPERIMENTAL | Subjects will receive TAF on Day 1, GLS4 and RTV on Day 5-14, GLS4 and RTV and TAF on Day15. |
| Part A:Group A | EXPERIMENTAL | Subjects will receive GLS4+RTV on Day 1,followed by ETV on Day11-21 and co-administration with GLS4+RTV on Day 21. |
| Part A:Group B | EXPERIMENTAL | Subjects will receive ETV on Day 1,followed by GLS4+RTV on Day11-21 and co-administration with ETV on Day 21. |
| Part B:Group C | EXPERIMENTAL | Subjects will receive GLS4+RTV on Day 1,followed by TDF on Day11-21 and co-administration with GLS4+RTV on Day 21. |
| Part B:Group D | EXPERIMENTAL | Subjects will receive TDF on Day 1,followed by GLS4+RTV on Day11-21 and co-administration with TDF on Day 21. |
| Name | Type | Description |
|---|---|---|
| GLS4 | DRUG | Administered GLS4 120 mg orally three times daily in fed state |
| RTV | DRUG | Administered RTV 100 mg orally three times daily in fed state |
| ETV | DRUG | Administered orally ETV 0.5 mg once daily in fasted state |
| TAF | DRUG | It is a hepatitis B virus (HBV) nucleoside analog reverse transcriptase inhibitor and is indicated for the treatment of chronic hepatitis B virus infection in adults with compensated liver disease. |
| TDF | DRUG | Administered TDF 300 mg orally once daily in fasted state |
Inclusion Criteria: * Chronic HBV infection population * HBeAg positive * HBsAg≥250 IU/mL * No cirrhosis Exclusion Criteria: * AST\>5×ULN * Platelet count less than 90E+09/L * TBil\>1.5×ULN * albumin\<35 g/L * INR\>1.5 * AFP\>50 ng/mL
GLS4 is an investigational small molecule being developed for chronic HBV infection and chronic hepatitis B. It is currently in Phase 2 clinical development and has not been approved by regulatory authorities.
GLS4 is a small molecule antiviral agent. Its specific molecular target has not been disclosed in the available clinical trial information, so its precise mechanism of action is not described here.
GLS4 is being developed by Sunshine Biopharma Inc., a company listed on the stock exchange under the ticker symbol SBFM.
GLS4 is in Phase 2 clinical development for chronic HBV infection and chronic hepatitis B. It is an investigational drug and has not received FDA approval.
GLS4 has completed three clinical trials, including two Phase 2 studies (NCT03638076 and NCT04147208) and two Phase 1 studies (NCT03662568 and NCT04551261). All trials were conducted in China and have been completed.
Yes, GLS4 is also known as morphothiadine mesilate. Clinical trials reference both names, with NCT03638076 and NCT03662568 using the morphothiadine mesilate name and NCT04147208 using GLS4.