2383086-06-2

Product Details:

CasNo： 2383086-06-2

Molecular Formula： C49H59N7O7S

Appearance： Light yellow to yellow powder

Packing： Aluminium bag

Throughput： 100KG/Month

Purity： 99%

Sonrotoclax, development code BGB‑11417, brand name BEQALZI, is a next‑generation, orally active, potent and selective small‑molecule BCL‑2 inhibitor discovered and developed by BeOne Medicines. It was designed with improved potency, target selectivity and binding kinetics compared with venetoclax, the first‑in‑class BCL‑2 inhibitor.

Basic Information

• Chemical Name: N‑[4‑([(1r,4r)-4-hydroxy-4-methylcyclohexyl]methylamino)-3-nitrobenzenesulfonyl]-4-(2-{(2S)-2-[2-(propan-2-yl)phenyl]pyrrolidin-1-yl}-7-azaspiro[3.5]nonan-7-yl)-2-[(1H-pyrrolo[2,3-b]pyridin-5-yl)oxy]benzamide
• CAS No.: 2763125-96-4
• Molecular Formula: C₄₉H₅₉N₇O₇S
• Molecular Weight: 922.11
• Appearance: White to off‑white solid powder
• Originator: BeOne Medicines
• Dosage Form: Oral tablet
• Recommended Dose: 320 mg once daily, following a 4‑week dose ramp‑up schedule

Mechanism of Action

Sonrotoclax selectively binds to the BH3 binding groove of the anti‑apoptotic BCL‑2 protein. It displaces pro‑apoptotic BH3‑only proteins, restores the intrinsic mitochondrial apoptotic pathway and triggers caspase‑dependent programmed cell death in BCL‑2‑dependent malignant lymphocytes. Compared with venetoclax, it exhibits stronger activity against certain BCL‑2 mutant variants associated with venetoclax resistance.

Indications

Accelerated approval by the US FDA for adult patients with relapsed or refractory mantle cell lymphoma (R/R MCL) who have received at least two lines of prior systemic therapy including a BTK inhibitor. Additional clinical investigations are ongoing for chronic lymphocytic leukemia / small lymphocytic lymphoma (CLL/SLL), Waldenström macroglobulinemia and other B‑cell malignancies, both as monotherapy and combined with zanubrutinib, anti‑CD20 antibodies and other agents.

Key Pharmacological & Clinical Features

• Administration: Oral, once‑daily dosing
• Differentiated profile: Higher BCL‑2 selectivity, shorter half‑life and minimal drug accumulation relative to venetoclax
• Core clinical data: In the pivotal trial for R/R MCL, the confirmed overall response rate was 52%; combination regimens with zanubrutinib have shown higher response and complete remission rates in early studies
• Major risks: Tumor lysis syndrome (TLS), neutropenia, thrombocytopenia, anaemia, diarrhoea and infection; TLS prophylaxis and monitoring are mandatory during dose escalation
• Designation: US FDA Breakthrough Therapy Designation and Orphan Drug Designation for mantle cell lymphoma

Regulatory Status

Granted accelerated approval by the US FDA in May 2026 for relapsed/refractory mantle cell lymphoma. Multiple registrational and exploratory clinical trials are ongoing globally. Approval in other regions including China is under review.