Molecular Formula (分子式):

C20H28N4O8

Molecular Weight (分子量)：

452.46

Contact Telephone (联系电话):

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Main Function

• 高生物利用度，攻克多肽给药难题：GLP-1RA 为多肽类大分子，易被胃肠道蛋白酶降解，FDKP 的肺部递送路径绕过胃肠道和肝脏首过效应，无需吸收促进剂即可实现高效跨肺泡吸收，临床数据显示其生物利用度远高于口服 GLP-1 制剂，大幅降低给药剂量和生产成本。

• 超快速起效，精准匹配生理节律：吸入给药后 10~15 分钟达血药峰浓度，是目前起效最快的 GLP-1 给药方式，完美匹配餐时血糖控制和餐前食欲抑制的需求，是传统注射、口服剂型无法实现的核心特性。

• 极低胃肠道不良反应，提升长期耐受性：从给药路径上规避了药物在胃肠道的局部高浓度暴露，临床 I 期数据显示其胃肠道不良反应发生率与安慰剂无显著差异，彻底解决了 GLP-1RA 停药率最高的核心痛点。

• 成熟的安全性与商业化验证：FDKP 已作为核心辅料在 FDA 获批的 Afrezza® 吸入胰岛素中上市应用超过 10 年，有充分的长期临床安全性数据，肺部局部耐受性、全身清除路径均已得到充分验证，无需重新验证辅料的安全性，大幅降低制剂开发的监管风险。

• 无创给药，患者依从性大幅提升：采用小型便携的干粉吸入器给药，无需注射，操作简单，隐私性强，患者接受度远高于注射笔，可显著提升长期治疗的依从性。

  
  

• High bioavailability to overcome the challenges of peptide deliveryGLP-1 receptor agonists (GLP-1RAs) are macromolecular peptides that are susceptible to degradation by gastrointestinal proteases. The pulmonary delivery route via FDKP bypasses the gastrointestinal tract and hepatic first-pass effect, enabling efficient transalveolar absorption without the need for absorption enhancers. Clinical data show that its bioavailability is far higher than that of oral GLP-1 formulations, which greatly reduces the required dosage and production cost.

• Ultra-rapid onset of action with precise matching of physiological rhythmsThe drug reaches peak plasma concentration within 10 to 15 minutes after inhalation administration, making it the fastest-acting GLP-1 delivery method currently available. It perfectly matches the requirements of prandial glycemic control and preprandial appetite suppression, a core feature that cannot be achieved by traditional injectable and oral dosage forms.

• Minimal gastrointestinal adverse events to improve long-term tolerabilityThis delivery route avoids high local drug exposure in the gastrointestinal tract. Phase I clinical data show that the incidence of its gastrointestinal adverse events is not significantly different from that of placebo, which thoroughly resolves the core pain point of the highest discontinuation rate of GLP-1RAs.

• Proven safety and commercial validationFDKP has been used as a core pharmaceutical excipient in the FDA-approved inhaled insulin product Afrezza® for more than 10 years since its launch, with sufficient long-term clinical safety data. Its local pulmonary tolerability and systemic clearance pathway have been fully validated, eliminating the need to re-verify the safety of the excipient and greatly reducing the regulatory risk of formulation development.

• Non-invasive administration to significantly improve patient adherenceIt is administered via a small, portable dry powder inhaler (DPI) without injection, featuring simple operation and strong privacy. Patient acceptance of this route is much higher than that of injection pens, which can significantly improve adherence to long-term treatment.