Drugs / naproxcinod
naproxcinod
Regulatory milestones approvals, filings & regulatory actions · 2 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Rejected (CRL) | US (FDA) | — | osteoarthritis | — | “We submitted an NDA for naproxcinod for osteoarthritis in 2009 and received a Complete Response Letter in 2010” nicox.com ↗ |
| Filed | US (FDA) | — | osteoarthritis | — | “We submitted an NDA for naproxcinod for osteoarthritis in 2009” nicox.com ↗ |
Trials 10
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 16 trials | ||||||
| Phase 1 | NCT01404598 | Jan → Feb 2010 | — | NicOx | Completed | No outcome recorded |
| Phase 1 | NCT00909519 | Jan → Apr 2009 | — | NicOx | Completed | No outcome recorded |
| Phase 1 | NCT00674856 | May → Sep 2008 | kidney failure | NicOx | Completed | No outcome recorded |
| Phase 1 | NCT00662610 | Mar → Aug 2008 | essential hypertension, osteoarthritis | NicOx | Completed | No outcome recorded |
| Phase 1 | NCT00662896 | Mar → Sep 2008 | essential hypertension, osteoarthritis | NicOx | Completed | No outcome recorded |
| Phase 1 | NCT00621881 | Jan → Apr 2008 | liver disorder | NicOx | Completed | No outcome recorded |
| Phase 21 trial | ||||||
| Phase 2 | NCT00383487 | Mar 2005 → Jul 2007 | prostate cancer | Stanford University | Terminated | No outcome recorded |
| Phase 33 trials · 2 met primary | ||||||
| Phase 3 | NCT00541489 | Jun 2007 → Sep 2008 | osteoarthritis, hip | NicOx | Completed | Met primary |
| Phase 3 | NCT00504127 | Apr 2007 → Dec 2008 | osteoarthritis | NicOx | Completed | No outcome recorded |
| Phase 3 | NCT00542555 | Dec 2005 → Sep 2007 | osteoarthritis | NicOx | Completed | Met primary |
News releases announcing trial results or a regulatory action · 1
| Date | Issuer | Release |
|---|---|---|
| 2022-03-02 | NicOx Inc. | Regulatory Nicox’s Partner Fera Pharmaceuticals Obtains Orphan Drug Designation from the U.S. FDA for Naproxcinod for the Treatment of Sickle Cell Disease nicox.com ↗
Nicox SA (Euronext Paris: FR0013018124, COX), an international ophthalmology company, and Fera Pharmaceuticals, a privately -held, U.S. specialty pharmaceutical company, today announced that the United States ( U.S.) Food and Drug Administration (FDA) has granted Orphan Drug Designation for naproxcinod for the treatment of sickle cell disease , which affects an estimated 100,000 Americans . |
All press releases naming this drug 1 release
| Date | Issuer | Release |
|---|---|---|
| 2022-03-02 | NicOx Inc. | Nicox’s Partner Fera Pharmaceuticals Obtains Orphan Drug Designation from the U.S. FDA for Naproxcinod for the Treatment of Sickle Cell Disease nicox.com ↗ |
Evidence & citations 9 cited values
Every value below carries the sentence it was read from. 12 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | naproxcinod | ClinicalTrials.gov intervention name — accepted as the source's own label NCT01404598 ↗ |
| Known as | AR-P900758XX | ChEMBL registry synonym — accepted as the source's own label CHEMBL2103831 ↗ |
| Known as | AZD-3582 | ChEMBL registry synonym — accepted as the source's own label CHEMBL2103831 ↗ |
| Known as | HCT 3012 | ChEMBL registry synonym — accepted as the source's own label CHEMBL2103831 ↗ |
| Known as | Naproxen-n-butyl nitrate | ClinicalTrials.gov intervention name — accepted as the source's own label NCT00383487 ↗ |
| Known as | Nitronaproxen | ChEMBL registry synonym — accepted as the source's own label CHEMBL2103831 ↗ |
| Action | Inhibit | “cyclooxygenase-inhibiting” PMID 20202489 ↗ Feb 2010 |
| Modality | Other / unclassified | “cyclooxygenase-inhibiting nitric-oxide donator, naproxcinod” PMID 20202489 ↗ Feb 2010 |
| Route | Oral | “400 mg BID, oral” NCT00383487 ↗ |