Drugs / Fespixon Cream
Trials 1
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 4 | NCT05338463 | Dec 2021 → Mar 2024 | chronic ulcer of skin | Cathay General Hospital | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 3
| Date | Issuer | Release |
|---|---|---|
| 2023-07-14 | Oneness Biotech Co., Ltd. | Regulatory 重大訊息－公告本公司「速必一乳膏（Fespixon cream）」獲衛生福利部中央健康保險署核准納入健保給付 onenessbio.com ↗
本公司「速必一乳膏（Fespixon cream）」獲衛生福利部中央健康保險署核准納入健保給付，核定支付價格為每條新台幣9,800元，自112年8月1日起正式生效。 |
| 2021-12-17 | Oneness Biotech Co., Ltd. | Regulatory 重大訊息－公告本公司ON101糖尿病足部傷口潰瘍新藥FESPIXON獲新加坡衛生科學局(HSA)正式受理註冊申請(NDA) onenessbio.com ↗
本公司今日接獲新加坡顧問公司通知，新加坡衛生科學局(HSA)正式受理FESPIXON糖尿病足部傷口潰瘍新藥註冊申請(NDA)。 |
| 2021-03-28 | Oneness Biotech Co., Ltd. | Regulatory 重大訊息－本公司糖尿病足部傷口潰瘍新藥「速必一」乳膏，(英文名: Fespixon cream)，接獲衛生福利部公函通知領取藥證 onenessbio.com ↗
本公司研發之糖尿病足部傷口潰瘍新藥 (研發代號ON101)，已通過新藥查驗登記，上市藥品命名為「速必一」乳膏，英文名為「Fespixon 」cream，業經衛生福利部核定同意領取藥證。 |
All press releases naming this drug 3 releases
| Date | Issuer | Release |
|---|---|---|
| 2023-07-14 | Oneness Biotech Co., Ltd. | 重大訊息－公告本公司「速必一乳膏（Fespixon cream）」獲衛生福利部中央健康保險署核准納入健保給付 onenessbio.com ↗ |
| 2021-12-17 | Oneness Biotech Co., Ltd. | 重大訊息－公告本公司ON101糖尿病足部傷口潰瘍新藥FESPIXON獲新加坡衛生科學局(HSA)正式受理註冊申請(NDA) onenessbio.com ↗ |
| 2021-03-28 | Oneness Biotech Co., Ltd. | 重大訊息－本公司糖尿病足部傷口潰瘍新藥「速必一」乳膏，(英文名: Fespixon cream)，接獲衛生福利部公函通知領取藥證 onenessbio.com ↗ |
Evidence & citations 2 cited values
Every value below carries the sentence it was read from. 1 source stands behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Fespixon Cream | ClinicalTrials.gov intervention name — accepted as the source's own label NCT05338463 ↗ |
| Route | Topical | “when applied topically to diabetic foot ulcers” NCT05338463 ↗ |