Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
APG-5918 · 1 trial · 1 indication
TEAEs will be assessed via CTCAE version 5.0 based on the frequency of adverse events/serious adverse events (AEs/SAEs), clinically significant laboratory test results, 12-lead ECGs, and vital signs.
| Arm | Type | Description |
|---|---|---|
| Single Ascending Dose (SAD) cohorts in Healthy Subjects (Part A) | EXPERIMENTAL | Subjects will be randomized to receive a single dose of APG-5918 or placebo. |
| Multiple Ascending Dose (MAD) cohorts in Anemic Patients (Part B) | EXPERIMENTAL | Subjects will receive once daily APG-5918 for 84 days or till EOT. |
| Name | Type | Description |
|---|---|---|
| APG-5918 | DRUG | oral tablets 10mg, 50mg, 200mg. |
| Placebo | DRUG | Matching placebo |
Inclusion Criteria: 1. Healthy Subjects: 1\. Age: 18 to 55 years. 2. Body Mass Index (BMI): 18-28 kg/m² (inclusive). 3. Hemoglobin value: 120 g/L-160 g/L (inclusive). 4. Normal body iron stores. 2. Anemic Subjects: 1. Age: ≥ 18 years. 2. Including beta-thalassemia and other related anemias, with ...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Bristol-Myers Squibb Company | BMY | 2 | PHASE3 | Luspatercept |
| Takeda Pharmaceutical Co. Ltd. Sponsored ADR | TAK | 2 | PHASE3 | Elritercept |
| Disc Medicine, Inc. | IRON | 2 | PHASE2 | DISC-0974 |
| Akebia Therapeutics, Inc. | AKBA | 2 | PHASE3 | Vadadustat |
| Ascentage Pharma Group International Unsponsored ADR | AAPG | 1 | PHASE1 | APG-5918 |
| Bayer | BAYRY | 1 | - | Molidustat |
APG-5918 is an investigational small molecule being developed for the treatment of anemia. It is currently in Phase 1 clinical development and is not yet approved by regulatory authorities. The drug is being studied in a clinical trial in China to evaluate its safety, pharmacokinetics, and preliminary efficacy in patients with anemia.
APG-5918 targets EED, a component of the polycomb repressive complex 2 (PRC2). By targeting EED, the drug may modulate gene expression pathways relevant to erythropoiesis and anemia. However, the precise mechanism of action in treating anemia is still under investigation in clinical trials.
APG-5918 is being developed by Ascentage Pharma Group International, a biopharmaceutical company listed on the stock exchange under the ticker AAPG. The company is conducting a Phase 1 clinical trial of APG-5918 in China to assess its safety and efficacy in patients with anemia.
APG-5918 is in Phase 1 clinical development. It is an investigational drug and has not received regulatory approval. The ongoing Phase 1 trial is recruiting participants and aims to evaluate the safety, pharmacokinetics, and preliminary efficacy of APG-5918 in patients with anemia.
APG-5918 is being studied in a Phase 1 clinical trial registered as NCT05773586. This trial is recruiting 105 participants in China and is designed to evaluate the safety, pharmacokinetics, and preliminary efficacy of APG-5918 in patients with anemia. The trial is randomized, double-blind, and controlled.