Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
AG-236 · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| Phase 2: AG-236 Dose X | EXPERIMENTAL | Subjects will receive AG-236 Dose X, administered subcutaneously (SC), according to the assigned dosing regimen, along with placebo administered SC as needed to maintain the blind in the double-blind period and will receive the same assigned AG-236 dose according to the protocol-defined regimen if they opt to participate in the extension period. |
| Phase 2: AG-236 Dose Y | EXPERIMENTAL | Subjects will receive AG-236 Dose Y, administered SC, according to the assigned dosing regimen, along with placebo administered SC as needed to maintain the blind in the double-blind period and will receive the same assigned AG-236 dose according to the protocol-defined regimen if they opt to participate in the extension period. |
| Phase 2: AG-236 Dose Z | EXPERIMENTAL | Subjects will receive AG-236 Dose Z, administered SC, according to the assigned dosing regimen, along with placebo administered SC as needed to maintain the blind in the double-blind period and will receive the same assigned AG-236 dose according to the protocol-defined regimen if they opt to participate in the extension period. |
| Phase 2: AG-236 Dose ZZ | EXPERIMENTAL | Subjects will receive AG-236 Dose ZZ, administered SC, according to the assigned dosing regimen in the double-blind period, and will receive the same assigned AG-236 dose according to the protocol-defined regimen if they opt to participate in the extension period. |
| Phase 2: Placebo | PLACEBO_COMPARATOR | Subjects will receive placebo administered SC, according to the assigned dosing regimen in the double-blind period and will be randomized to receive AG-236 Dose X, Y, or Z if they opt to participate in the extension period. |
| Phase 3: AG-236 | EXPERIMENTAL | Subjects will receive AG-236, administered SC at the dose and dose regimen selected for Phase 3 for 26 weeks in the double-blind period. Subjects who complete the double-blind period of the study will be eligible to continue receiving AG-236 in the open-label extension period. |
| Phase 3: Placebo | PLACEBO_COMPARATOR | Subjects will receive placebo administered SC at the dose and dose regimen selected for Phase 3 for 26 weeks in the double-blind period. Subjects who complete the double-blind period of the study will be eligible to continue receiving AG-236 in the open-label extension period. |
| Name | Type | Description |
|---|---|---|
| AG-236 | DRUG | SC Injection |
| Placebo | DRUG | SC Injection |
Key Inclusion Criteria: * PV diagnosis according to 2022 World Health Organization (WHO) criteria. * Phlebotomy requirements: * At least 3 documented phlebotomies in the 6 months before randomization or at least 5 documented phlebotomies in the 12 months before randomization; and * At least 1 ...
Top 6 of 7 competitors
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Merck & Co., Inc. | MRK | 2 | PHASE3 | Bomedemstat |
| Protagonist Therapeutics, Inc. | PTGX | 2 | PHASE3 | Rusfertide |
| Disc Medicine, Inc. | IRON | 1 | PHASE2 | DISC-3405 |
| Takeda Pharmaceutical Co. Ltd. Sponsored ADR | TAK | 3 | PHASE2 | Rusfertide |
| Agios Pharmaceuticals, Inc. | AGIO | 1 | PHASE2 | AG-236 |
| Prelude Therapeutics, Inc. | PRLD | 1 | PHASE1 | PRT12396 |
AG-236 is an investigational small molecule being developed by Agios Pharmaceuticals, Inc. for the treatment of polycythemia vera, a hematologic condition. It is currently in Phase 2 clinical development and has not been approved by the FDA. The drug is designed to target TMPRSS6.
AG-236 is being studied as a treatment for polycythemia vera, a blood disorder characterized by overproduction of red blood cells. It is an investigational therapy in Phase 2 development and is not yet approved for any indication. The ongoing trial is evaluating its use in adults with this condition.
AG-236 targets TMPRSS6, a transmembrane serine protease. By inhibiting TMPRSS6, the drug is designed to modulate iron metabolism and erythropoiesis. This mechanism is being explored in polycythemia vera, where excessive red blood cell production is a hallmark.
AG-236 is being developed by Agios Pharmaceuticals, Inc., a biopharmaceutical company focused on hematology. The company trades on the Nasdaq under the ticker symbol AGIO. Agios is responsible for the clinical development of AG-236.
AG-236 is in Phase 2 clinical development. The only trial listed is a Phase 2 study that is not yet recruiting. The drug is investigational and has not been approved by the FDA for any indication.
AG-236 is being evaluated in one Phase 2 clinical trial, NCT07859423, titled "A Study to Investigate AG-236 in Subjects ≥18 Years of Age With Polycythemia Vera." The trial is not yet recruiting and is expected to enroll 245 participants. It is a randomized, double-blind, placebo-controlled study.