Drugs / AP301
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed | China (NMPA) | — | hyperphosphatemia | 2026-08-07 | “公司管线产品AP301胶囊（一款新型口服含铁磷结合剂）用于治疗接受维持性透析的慢性肾脏病（CKD）患者高磷血症的新药上市申请（NDA），今日获中国国家药品监督管理局（NMPA）受理。” alebund.com ↗ |
Trials 6
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial | ||||||
| Phase 1 | NCT06100627 | Jan → Feb 2024 | — | Alebund Pty Ltd | Completed | No outcome recorded |
| Phase 23 trials · 1 missed | ||||||
| Phase 2 | NCT03567577 | May 2018 → Dec 2024 | acute respiratory distress syndrome | Apeptico Forschung und Entwicklung GmbH | Completed | No outcome recorded |
| Phase 2 | NCT02095626 | Jun 2013 → Mar 2015 | — | Apeptico Forschung und Entwicklung GmbH | Completed | No outcome recorded |
| Phase 2 | NCT01627613 | Jul 2012 → May 2014 | acute lung injury | Apeptico Forschung und Entwicklung GmbH | Completed | Missed primary |
| Phase 32 trials | ||||||
| Phase 3 | NCT06933472 | Jun 2025 → Jun 2026 overdue | end stage renal failure, hyperphosphatemia | Alebund Pharmaceuticals | Recruiting | No outcome recorded |
| Phase 3 | NCT07030595 | Jun 2023 → Oct 2024 | end stage renal failure, hyperphosphatemia | Alebund Pharmaceuticals | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 10
| Date | Issuer | Release |
|---|---|---|
| 2026-08-07 | Alebund Pharmaceuticals | Regulatory 礼邦医药AP301新药上市申请获国家药监局受理 alebund.com ↗
上海，2026年8月7日——礼邦医药（江苏）股份有限公司（以下简称“礼邦医药”或“公司”，股票代码：09637.HK），一家聚焦肾脏疾病领域的生物医药企业，今日宣布，公司管线产品AP301胶囊（一款新型口服含铁磷结合剂）用于治疗接受维持性透析的慢性肾脏病（CKD）患者高磷血症的新药上市申请（NDA），今日获中国国家药品监督管理局（NMPA）受理。 |
| 2025-11-07 | Alebund Pharmaceuticals | Results 礼邦医药在 2025 年美国肾脏病年会上公布其磷结合剂 AP301 的 Ⅲ 期临床试验数据 alebund.com ↗
治疗至第 12 周，AP301 在降低血清磷水平方面非劣于碳酸司维拉姆。 |
| 2025-11-01 | Apeptico Forschung und Entwicklung GmbH | Results Safety and tolerability of Solnatide have been confirmed in a Phase IIB clinical study apeptico.com ↗
Safety and tolerability of Solnatide have been confirmed in a Phase IIB clinical study |
| 2025-06-26 | Alebund Pharmaceuticals | Results 礼邦医药宣布 AP301 治疗透析患者高磷血症的关键性 Ⅲ 期研究达到主要疗效终点 alebund.com ↗
该研究达到主要疗效及安全性终点。 |
| 2022-11-01 | Apeptico Forschung und Entwicklung GmbH | Results Solnatide peptide expressed potent anti-inflammatory activity in joints apeptico.com ↗
solnatide peptide reduced cell influx and release of pro -inflammatory mediators into the joints, associated with reduction in oedema and tissue damage, as compared to controls |
| 2020-04-28 | Apeptico Forschung und Entwicklung GmbH | Regulatory SOLNATIDE has been approved for the treatment of COVID-19 patients apeptico.com ↗
SOLNATIDE has been approved for the treatment of COVID-19 patients suffering from pulmonary oedema and acute respiratory distress syndrome by the Italian Medicines Agency and the Ethics Committee of the National Institute for Infectious Diseases (Lazzaro Spallanzani-Rome) |
| 2020-04-07 | Apeptico Forschung und Entwicklung GmbH | Regulatory SOLNATIDE has been approved by the apeptico.com ↗
SOLNATIDE has been approved by the Austrian Federal Office for Safety in Health Care for the treatment of COVID-19 patients with severe pulmonary dysfunction |
| 2020-03-11 | Apeptico Forschung und Entwicklung GmbH | Results L E T T E R Open Access apeptico.com ↗
Trial specific outcomes regarding pulmonary edema and ventilation parameters did not differ between the groups, nor did more general indicators of (pulmonary) sepsis like oxygenation ratio and required noradrenaline doses. |
| 2015-12-01 | Apeptico Forschung und Entwicklung GmbH | Regulatory The Committee for Orphan Medicinal Products of the European Medicines Agency grants apeptico.com ↗
The Committee for Orphan Medicinal Products of the European Medicines Agency grants orphan drug designation to APEPTICO’s development compounds AP301 and AP318 for treatment of for treatment of Pseudohypoaldosteronism Type 1B |
| 2011-10-25 | Apeptico Forschung und Entwicklung GmbH | Results APEPTICO Announces Successful Completion of Phase I Trial apeptico.com ↗ |
All press releases naming this drug 13 releases
Evidence & citations 4 cited values
Every value below carries the sentence it was read from. 7 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | AP301 | “orally delivered doses of 87.6 mg AP301 (dose per subject, 5 ml nebulizer filling dose) are inhaled every 12 hours for a total of 7 days” NCT02095626 ↗ |
| Known as | Solnatide | ClinicalTrials.gov intervention name — accepted as the source's own label NCT03567577 ↗ |
| Action | Activate | “AP301 enhances AFC by activating epithelial sodium channels (ENaCs) on alveolar epithelial cells” PMID 28750677 ↗ Jul 2017 |
| Route | Inhaled | “Patients were treated with inhaled AP301 (n = 20) or placebo (0.9% NaCl; n = 20) twice daily for 7 days.” PMID 28750677 ↗ Jul 2017 |