Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Fostemsavir (FTR)
Fostemsavir · 2 trials · 1 indication
A SAE is defined as any untoward medical occurrence that, at any dose, results in results in death, is life- threatening, requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study participant, abnormal pregnancy outcomes or a suspected transmission of any infectious agent via an authorized medicinal product.
An adverse event (AE) is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AESI is defined as an AE of a scientific and medical concern specific to the study intervention, which may require further investigation in order to characterize and understand it.
| Arm | Type | Description |
|---|---|---|
| Continued Access Group | EXPERIMENTAL | Participants with HIV-1 who received the study intervention and completed the protocol-defined treatment period in ViiV Healthcare-sponsored or ViiV Healthcare-collaborative parent studies (2020-001029-30, 2020-001426-57), and who continue to receive the study intervention from their respective parent study. |
| Part 1: Treatment sequence ABC | EXPERIMENTAL | Participants will receive FTR 3×200 mg ER tablets (Treatment A) in Period 1 followed by FTR 3×200 mg ER tablets (Treatment B) in Period 2 followed by FTR 600 mg ER tablet (Treatment C, reference) in Period 3. |
| Part 1: Treatment sequence BCA | EXPERIMENTAL | Participants will receive FTR 3×200 mg ER tablets (Treatment B) in Period 1 followed by FTR 600 mg ER tablet (Treatment C, reference) in Period 2 followed by FTR 3×200 mg ER tablets (Treatment A) in Period 3. |
| Part 1: Treatment sequence CAB | EXPERIMENTAL | Participants will receive FTR 600 mg ER tablet in Period 1 (Treatment C, reference) followed by FTR 3×200 mg ER tablets (Treatment A) in Period 2 followed by FTR 3×200 mg ER tablets (Treatment B) in Period 3. |
| Part 1: Treatment sequence ACB | EXPERIMENTAL | Participants will receive FTR 3×200 mg ER tablets (Treatment A) in Period 1 followed by FTR 600 mg ER tablet (Treatment C, reference) in Period 2 followed by FTR 3×200 mg ER tablets (Treatment B) in Period 3. |
| Part 1: Treatment sequence BAC | EXPERIMENTAL | Participants will receive FTR 3×200 mg ER tablets (Treatment B) in Period 1 followed by FTR 3×200 mg ER tablets (Treatment A) in Period 2 followed by FTR 600 mg ER tablet (Treatment C, reference) in Period 3. |
| Part 1: Treatment sequence CBA | EXPERIMENTAL | Participants will receive FTR 600 mg ER tablet (Treatment C, reference) in Period 1 followed by FTR 3×200 mg ER tablets (Treatment B) in Period 2 followed by FTR 3×200 mg ER tablets (Treatment A) in Period 3. |
| Part 2: Treatment sequence DE | EXPERIMENTAL | Participants will receive the selected low-dose formulation of FTR 3 × 200 mg ER tablets in a fasted state (Treatment D) in Period 1 and following a high fat high calorie meal (Treatment E) in Period 2. |
| Part 2: Treatment sequence ED | EXPERIMENTAL | Participants will receive the selected low-dose formulation of FTR 3 × 200 mg ER tablets following a high fat high calorie meal (Treatment E) in Period 1 and in a fasted state (Treatment D) in Period 2. |
| Name | Type | Description |
|---|---|---|
| Fostemsavir | DRUG | Participants receive oral tablets with the dosages depending on the weight of the participants. |
| Dolutegravir (DTG)/ Lamivudine (3TC) | DRUG | Participants receive oral tablets with the dosages depending on the weight of the participants. |
| Fostemsavir 600 mg | DRUG | Fostemsavir tablets will be administered via oral route. |
| Fostemsavir 200 mg | DRUG | Fostemsavir tablets will be administered via oral route. |
Inclusion Criteria: * Investigator confirmation of the participant's continued clinical benefit from the parent study intervention and the participant's completion of the protocol-defined treatment period in the parent study. The Investigator should ensure that the participant is still eligible for...
Top 20 of 28 competitors
Fostemsavir is used for the treatment of HIV infections. It is a small molecule drug being developed by GSK plc (GSK) for this infectious disease indication. The drug is currently in Phase 3 clinical development, with ongoing studies evaluating its use in patients with HIV.
Fostemsavir is an attachment inhibitor that targets the HIV-1 gp120 protein, preventing the virus from attaching to and entering host CD4+ T cells. By blocking this initial step of viral entry, Fostemsavir inhibits HIV replication. This mechanism is specific to HIV-1 and is being studied in patients with HIV infections.
Fostemsavir is being developed by GSK plc, a global biopharma company listed on the London Stock Exchange under the ticker GSK. The drug is being studied for the treatment of HIV infections and is currently in Phase 3 clinical development.
Fostemsavir is in Phase 3 clinical development for the treatment of HIV infections. It is an investigational drug, meaning it has not yet been approved by regulatory authorities. The Phase 3 program includes a continued access study for participants transitioning from earlier ViiV Healthcare-sponsored or collaborative parent studies.
Fostemsavir has two clinical trials listed. NCT04757974 is a completed Phase 1 relative bioavailability study with 32 participants. NCT07393659 is a recruiting Phase 3 continued access study with 181 participants, conducted in South Africa for HIV treatment. Both trials enroll patients with HIV infections.
Yes, Fostemsavir is also known as FTR. This abbreviation is used in clinical and research contexts to refer to the same drug. Fostemsavir (FTR) is being developed by GSK plc for the treatment of HIV infections and is currently in Phase 3 clinical development.