drugset
Drugs / NR082
last change Jul 2025 re-read 3 minutes ago

NR082

Developed for
Leber hereditary optic neuropathy
Investigated by
Neurophth Therapeutics Inc · Wuhan Neurophth Biotechnology Limited Company

Trials 2

today NCT05293626 · Ph 1/2 NCT04912843 · Ph 2/3
20222023202420252026
PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 1/21 trial
Phase 1/2 NCT05293626 May 2023 → Jul 2025 overdue Leber hereditary optic neuropathy Neurophth Therapeutics Inc Active not recruiting No outcome recorded
Phase 2/31 trial
Phase 2/3 NCT04912843 Jun 2021 → Feb 2024 overdue Leber hereditary optic neuropathy Wuhan Neurophth Biotechnology Limited Company Recruiting No outcome recorded

News releases announcing trial results or a regulatory action · 3

DateIssuerRelease
2023-12-22 Neurophth Therapeutics Inc Results NFS-01（NR082, 商品名：纽惟佳®）治疗的阿根廷LHON-ND4患者的5年随访 neurophth.com ↗
在完成了5年随访的9位患者中，6人给药眼视力改善显著，均超过0.3LogMAR，且5年间一直保持了视力的获益，学习和生活质量获得了根本性的改善。
2020-12-03 Neurophth Therapeutics Inc Results 专访纽福斯陆英明：“孤儿药”将在中美提交IND并推向产业化，除眼科外还将扩展更多管线 neurophth.com ↗
2011 年在中国启动的试验性 NR082 基因治疗临床试验结果显示，在参与试验的 9 例 ND4 位点突变 LHON 患者中，6 例患者注射后 36 个月的视力得到明显改善，最佳视力恢复到 0.8，9 名患者平均最佳矫正视力提高 0.56LogMAR（即接近字母表六行的提高）。
2020-09-24 Neurophth Therapeutics Inc Regulatory 重磅！首个中国籍体内基因疗法获FDA孤儿药认定，纽福斯为LHON患者带来光明新希望 neurophth.com ↗
2020年9月24日，纽福斯全资子公司Neurophth Therapeutics，Inc. 宣布其明星产品NR082（NFS-01项目）获美国FDA孤儿药认定（ODD），用于治疗ND4突变引起的Leber’s遗传性视神经病变。

All press releases naming this drug 3 releases

DateIssuerRelease

Evidence & citations 2 cited values

Every value below carries the sentence it was read from. 2 sources stand behind the page.

FieldValueCited text
Known as NR082 ClinicalTrials.gov intervention name — accepted as the source's own label NCT04912843 ↗
1

NCT05293626 ↗
Route Intravitreal “single unilateral intravitreal (IVT) injection of NR082” NCT04912843 ↗