Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
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 completed three trials in China involving 250 patients. The drug is not yet approved and remains under investigation for safety and antiviral activity.
GLS4 is a small molecule antiviral agent designed to treat chronic hepatitis B and chronic HBV infection. Its mechanism of action involves targeting the hepatitis B virus to reduce viral replication. The drug has been studied in combination with ritonavir to enhance its antiviral effects in patients with chronic HBV infection.
GLS4 is being developed by Sunshine Biopharma Inc., a company traded on the stock exchange under the ticker symbol SBFM. The company is conducting clinical trials for GLS4 in China, focusing on chronic hepatitis B and chronic HBV infection. The drug is currently in Phase 2 development.
GLS4 is in Phase 2 clinical development for chronic HBV infection and chronic hepatitis B. It has completed three clinical trials, including two Phase 2 studies and two Phase 1 studies. The drug remains investigational and has not received FDA approval, as it is still being evaluated for safety and efficacy.
GLS4 has completed three clinical trials in China. These include NCT03638076, a Phase 2 study of morphothiadine mesilate capsules in chronic hepatitis B; NCT03662568, a Phase 1 drug-drug interaction study with ritonavir in healthy subjects; and NCT04147208, a Phase 2 study of GLS4 with ritonavir in chronic HBV infection. All trials are completed.
GLS4 is also known as morphothiadine mesilate, as seen in clinical trial titles. The drug has been studied under both names, with trials referencing morphothiadine mesilate capsules and GLS4 with ritonavir. Both names refer to the same investigational compound for chronic hepatitis B and HBV infection.