Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
AMG 623 · 2 trials · 1 indication
| Arm | Type | Description |
|---|---|---|
| AMG 623 | EXPERIMENTAL | Multiple doses of AMG 623 administered as subcutaneous and intravenous doses |
| Placebo | PLACEBO_COMPARATOR | Multiple doses of AMG 623 administered as subcutaneous and intravenous doses |
| Name | Type | Description |
|---|---|---|
| AMG 623 | DRUG | Multiple doses of AMG 623 administered as subcutaneous and intravenous doses |
| Placebo | DRUG | Multiple doses of AMG 623 administered as subcutaneous and intravenous doses |
Inclusion Criteria: * Men and women between the ages of 18 and 65 years old * Diagnosis of SLE * Stable disease; defined as no change in SLE therapy within the previous 30 days. Up to 5 mg/day incremental changes of prednisone therapy is allowed during the 30 days prior to randomization * SLE disea...
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 |
AMG 623 is an investigational small molecule being developed for the treatment of Systemic Lupus Erythematosus (SLE). It is currently in Phase 1 clinical development, meaning it is still being studied for safety and tolerability in patients and has not yet been approved by regulatory authorities.
AMG 623 is being developed by Amgen Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol AMGN. The company is conducting clinical trials to evaluate the drug's safety, pharmacokinetics, and pharmacodynamics in patients with Systemic Lupus Erythematosus.
AMG 623 is in Phase 1 clinical development. Two Phase 1 trials have been completed, both focusing on safety, pharmacokinetics, and pharmacodynamics in subjects with Systemic Lupus Erythematosus. The drug is investigational and has not received FDA approval.
AMG 623 has two completed Phase 1 clinical trials: NCT02411136, which examined safety, pharmacokinetics, and pharmacodynamics in 64 subjects with Systemic Lupus Erythematosus, and NCT02443506, which studied a single dose in 56 subjects with the same condition. Both trials were randomized, double-blind, and placebo-controlled.
No, AMG 623 is not FDA approved. It is an investigational drug currently in Phase 1 clinical development for Systemic Lupus Erythematosus. The two completed trials were designed to assess safety, pharmacokinetics, and pharmacodynamics, and further studies would be needed before any approval could be considered.