Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
GSK4527363 · 1 trial · 1 indication
The C-SSRS is an assessment tool that evaluates suicidal ideation and behavior. A suicidal ideation score will be calculated based on the maximum suicidal ideation category ranging from 1 to 5. Higher score indicates more suicidal ideation. A clinically important change in the C-SSRS is defined as a total score \>0.
The C-SSRS is an assessment tool that evaluates suicidal ideation and behavior. A suicidal ideation score will be calculated based on the maximum suicidal ideation category ranging from 1 to 5. Higher score indicates more suicidal ideation. A clinically important change in the C-SSRS is defined as a total score \>0.
| Arm | Type | Description |
|---|---|---|
| Part A: Healthy participants receiving GSK4527363 | EXPERIMENTAL | - |
| Part A: Healthy participants receiving placebo matching GSK4527363 | PLACEBO_COMPARATOR | - |
| Part A: Healthy participants receiving belimumab | EXPERIMENTAL | - |
| Part B: Participants with SLE receiving GSK4527363 | EXPERIMENTAL | - |
| Part B: Participants with SLE receiving belimumab | EXPERIMENTAL | - |
| Part C: Healthy Japanese participants receiving GSK4527363 | EXPERIMENTAL | - |
| Part C: Healthy Japanese participants receiving placebo matching GSK4527363 | PLACEBO_COMPARATOR | - |
| Part C: Healthy Chinese participants receiving GSK4527363 | EXPERIMENTAL | - |
| Part C: Healthy Chinese participants receiving placebo matching GSK4527363 | PLACEBO_COMPARATOR | - |
| Part D: Participants with CTD-ILD receiving GSK4527363 | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| GSK4527363 | DRUG | GSK4527363 will be administered to participants. |
| Placebo matching GSK4527363 | DRUG | Placebo matching GSK4527363 will be administered to participants. |
| Belimumab | DRUG | Belimumab will be administered to participants. |
Inclusion criteria: For Part A and Part C (Healthy Participants): * Participant must be 18 to 55 years of age inclusive, at the time of signing the informed consent form * Participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, labo...
Top 20 of 32 competitors
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Biogen Inc. | BIIB | 5 | PHASE3 | Litifilimab |
| Bristol-Myers Squibb Company | BMY | 7 | PHASE3 | Deucravacitinib |
| Viatris, Inc. | VTRS | 5 | PHASE3 | Cenerimod |
| Novartis AG Sponsored ADR | NVS | 7 | PHASE3 | Ianalumab |
| AstraZeneca PLC | AZN | 21 | PHASE3 | Medi-546 |
| Johnson & Johnson | JNJ | 1 | PHASE3 | Nipocalimab |
| AbbVie, Inc. | ABBV | 2 | PHASE3 | Upadacitinib |
| GSK plc Sponsored ADR | GSK | 3 | PHASE2 | Belimumab |
| Sanofi SA Sponsored ADR | SNY | 2 | PHASE2 | SAR441344 |
| Zenas BioPharma, Inc. | ZBIO | 1 | PHASE2 | Obexelimab |
| Alumis Inc. | ALMS | 1 | PHASE2 | Envudeucitinib |
| Immunovant Inc | IMVT | 1 | PHASE2 | IMVT-1402 |
| Amgen Inc. | AMGN | 1 | PHASE2 | Inebilizumab, Blinatumomab |
| Fate Therapeutics, Inc. | FATE | 2 | PHASE2 | FT819 |
| Eli Lilly and Company | LLY | 1 | PHASE1 | LY4298445 |
| Cartesian Therapeutics, Inc. | RNAC | 2 | PHASE2 | Descartes-08 |
| Merck & Co., Inc. | MRK | 1 | PHASE1 | MK-1045 |
| Gilead Sciences, Inc. | GILD | 1 | PHASE1 | KITE-363, Fludarabine, Cyclophosphamide |
| Artiva Biotherapeutics, Inc. | ARTV | 2 | PHASE1 | AB-101, Cyclophosphamide, Fludarabine, Rituximab, Obinutuzumab |
| Cullinan Therapeutics, Inc. | CGEM | 1 | PHASE1 | CLN-978 |
GSK4527363 is an investigational small molecule being developed for Systemic Lupus Erythematosus (SLE). It is currently in Phase 1 clinical development and is not yet approved by regulatory authorities. The drug is being studied in healthy participants as well as in patients with SLE.
GSK4527363 is being developed by GSK plc, a global biopharma company listed on the London Stock Exchange under the ticker GSK. The company is conducting a Phase 1 clinical trial to evaluate the drug in healthy participants and patients with Systemic Lupus Erythematosus.
GSK4527363 is in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA or any other regulatory agency. The ongoing Phase 1 trial is currently recruiting participants and is designed to evaluate the drug in healthy volunteers and patients with Systemic Lupus Erythematosus.
GSK4527363 is being studied in a single Phase 1 clinical trial registered as NCT06576271. This randomized, double-blind, placebo-controlled study is recruiting 142 participants across the United States, Argentina, Brazil, Poland, Spain, and the United Kingdom. The trial includes healthy participants, SLE patients, healthy Chinese and Japanese participants, and CTD-ILD participants.
No alternative names for GSK4527363 have been disclosed. The drug is identified solely by its development code GSK4527363 in the ongoing clinical trial. It is a small molecule being investigated for the treatment of Systemic Lupus Erythematosus.