Drugs / APP13007
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed | US (FDA) | — | chronic orbital inflammation | 2023-05-05 | “acceptance of its New Drug Application for APP13007, a novel aqueous nanosuspension formulation of the potent corticosteroid” formosapharma.com ↗ “announce the submission of a New Drug Application to the United States Food & Drug Administration (US FDA) for APP13007” formosapharma.com ↗ “GPN00833 (APP13007)已向美国食品药品监督管理局(FDA)递交了新药上市申请(NDA)。” grandpharm.com ↗ |
Trials 2
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 3 | NCT04810962 | Mar 2021 → Jul 2022 | — | Formosa Pharmaceuticals, Inc. | Completed | Met primary |
| Phase 3 | NCT04739709 | Jan 2021 → Mar 2022 | — | Formosa Pharmaceuticals, Inc. | Completed | Met primary |
News releases announcing trial results or a regulatory action · 19
| Date | Issuer | Release |
|---|---|---|
| 2024-11-04 | Formosa Pharmaceuticals, Inc. | Results Formosa Pharmaceuticals Announces Successful Top-Line Results from CPN-303, a Phase 3 Trial in Chinese Subjects for the Treatment of Inflammation and Pain after Cataract Surgery formosapharma.com ↗
Treatment with an APP13007 eyedrop twice daily for 14 days achieved both primary endpoints by producing rapid and sustained clearance of ocular inflammation and cure of ocular pain which were clinically and statistically superior to placebo. |
| 2024-03-11 | GrandPharma (China) Co., Ltd. | Regulatory 远大医药两款全球创新眼科产品获重要进展，GPN00833新药上市申请获美国FDA批准，GPN00884在中国获批开展I期临床研究 grandpharm.com ↗
本集团在眼科领域的合作伙伴台新药股份有限公司公布了其用于眼科术后抗炎镇痛的激素纳米混悬滴眼液GPN00833 (APP13007)的新药上市申请(NDA)近日正式获得美国食品药品监督管理局(FDA)的批准。 |
| 2024-03-06 | Nxera Pharma UK Limited | Regulatory Sosei Heptares to receive US$2.5 million milestone payment from Formosa Pharmaceuticals nxera.life ↗ |
| 2024-03-06 | Nxera Pharma UK Limited | Regulatory Other nxera.life ↗ |
| 2024-03-05 | Formosa Pharmaceuticals, Inc. | Regulatory Formosa Pharmaceuticals and AimMax Therapeutics Receive FDA Approval for Clobetasol Propionate Ophthalmic Suspension 0.05%, for the Treatment of Post-Operative Inflammation and Pain Following Ocular Surgery formosapharma.com ↗ |
| 2023-07-05 | Formosa Pharmaceuticals, Inc. | Regulatory Formosa Pharmaceuticals Announce FDA Acceptance of NDA Filing for APP13007 for the Treatment of Post-Operative Inflammation and Pain following Ocular Surgery formosapharma.com ↗
Formosa Pharmaceuticals, Inc. ( 6838 .TWO) announce the United States Food & Drug Administration (US FDA) acceptance of its New Drug Application for APP13007, a novel aqueous nanosuspension formulation of the potent corticosteroid, clobetasol propionate (0.05%), for the treatment of inflammation and pain following ocular surgery. |
| 2023-05-12 | GrandPharma (China) Co., Ltd. | Regulatory 远大医药全球创新眼科药物GPN00833向美国FDA递交新药上市申请 grandpharm.com ↗
近日，远大医药(0512.HK)在眼科领域的合作伙伴台新药股份有限公司公布了其用于抗炎镇痛的激素纳米混悬滴眼液GPN00833 (APP13007)已向美国食品药品监督管理局(FDA)递交了新药上市申请(NDA)。 |
| 2023-05-05 | Formosa Pharmaceuticals, Inc. | Regulatory Formosa Pharmaceuticals and AimMax Therapeutics Announce the NDA Submission to the US FDA for APP13007 for the Treatment of Post-Operative Inflammation and Pain following Ocular Surgery formosapharma.com ↗ |
| 2023-04-13 | GrandPharma (China) Co., Ltd. | Regulatory 远大医药全球创新眼科药物GPN00833的中国III期临床试验申请获国家药监局默示许可 grandpharm.com ↗
近日，远大医药(0512.HK)用于抗炎镇痛的激素纳米混悬滴眼液GPN00833 (APP13007)的III期临床试验申请已获得国家药监局临床试验默示许可，是公司在眼科疾病治疗领域的重要研发进展。 |
| 2023-04-12 | GrandPharma (China) Co., Ltd. | Results 远大医药全球创新激素纳米混悬滴眼液APP13007海外III期临床研究顺利达到临床终点 grandpharm.com ↗
近日，远大医药(00512.HK)在眼科领域的合作伙伴台新药股份有限公司公布了其用于抗炎镇痛的激素纳米混悬滴眼液APP13007在美国开展的II期临床研究和两项III期临床研究，均已顺利达到临床终点。 |
| 2023-02-27 | GrandPharma (China) Co., Ltd. | Regulatory 新序启 | 远大医药产品收获新进展（2月篇） grandpharm.com ↗
两款眼科产品获中国IND申请获受理 |
| 2023-01-31 | Formosa Pharmaceuticals, Inc. | Results Formosa Pharmaceuticals Announce a Summary of Integrated Clinical Results for APP13007 for the Treatment of Inflammation and Pain after Cataract Surgery formosapharma.com ↗
Across all trials, treatment with an APP13007 eyedrop twice daily for 14 days consistently achieved both primary endpoints by producing rapid and sustained clearance of ocular inflammation and cure of ocular pain which were statistically and clinically superior to placebo. |
| 2023-01-30 | GrandPharma (China) Co., Ltd. | Regulatory 远大医药三款全球创新产品中国IND申请获受理，多板块业务协同推进 grandpharm.com ↗
近日，远大医药(00512.HK)在呼吸及重症抗感染以及眼科板块的三款全球创新药物的新药临床试验(IND)申请已获得国家药监局(NMPA)正式受理，为本集团在上述疾病治疗领域的重要研发进展。 |
| 2022-08-10 | Formosa Pharmaceuticals, Inc. | Results Formosa Pharmaceuticals and AimMax Therapeutics Announce Successful Top-Line Results from CPN-302 for the Treatment of Inflammation and Pain after Cataract Surgery. formosapharma.com ↗
Treatment with an APP13007 eyedrop twice daily for 14 days achieved both primary endpoints by producing rapid and sustained clearance of ocular inflammation and cure of ocular pain which were statistically (p<0.001) and clinically superior to placebo. |
| 2022-05-18 | Formosa Pharmaceuticals, Inc. | Results Formosa Pharmaceuticals and AimMax Therapeutics to Present Phase 2 Trials Results of APP13007 for the Treatment of Inflammation and Pain after Cataract Surgery at The Association for Research in Vision and Ophthalmology (ARVO) 2022 Annual Meeting formosapharma.com ↗
In this Phase 2 study, APP13007 was well tolerated with a safety profile similar to placebo. |
| 2022-05-12 | Formosa Pharmaceuticals, Inc. | Results Formosa Pharmaceuticals and AimMax Therapeutics Announce Successful Top-Line Results from CPN-301 for the Treatment of Inflammation and Pain after Cataract Surgery formosapharma.com ↗
Treatment with an APP13007 eyedrop twice daily for 14 days met the two primary endpoints by producing rapid and sustained clearance of ocular inflammation and cure of ocular pain which were statistically and clinically superior to placebo. |
| 2020-09-14 | Formosa Pharmaceuticals, Inc. | Results APP13007 completes Phase 2 clinical trial and EOP2 meeting. formosapharma.com ↗
Formosa Pharmaceuticals and AimMax Therapeutics report top-line results from a Phase 2 clinical trial of APP13007 for the treatment of inflammation and pain after cataract surgery. |
| 2019-07-18 | Nxera Pharma UK Limited | Regulatory Other nxera.life ↗ |
| 2019-07-18 | Nxera Pharma UK Limited | Regulatory Sosei Heptares to receive US$2.5 million milestone payment from Formosa Pharmaceuticals nxera.life ↗
Formosa Pharmaceuticals, Inc. (“Formosa”) has received approval from the US Food and Drug Administration (“FDA”) of its Investigational New Drug (“IND”) application for APP13007 to commence a first-in-human (“FIH”) clinical trial in the United States. |
All press releases naming this drug 27 releases
Evidence & citations 2 cited values
Every value below carries the sentence it was read from. 2 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | APP13007 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT04810962 ↗ |
| Route | Topical | “APP13007 eye drop, 0.05%” NCT04810962 ↗ |