Trial Profile
Phase III Multicenter Prospective Randomized Parallel-Group Placebo-Controlled Double Blind Clinical Evaluation of NX-1207 for the Treatment of BPH NX02-0018.
Status:
Completed
Phase of Trial:
Phase III
Latest Information Update: 27 May 2022
Price :
$35
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At a glance
- Drugs Fexapotide (Primary)
- Indications Benign prostatic hyperplasia
- Focus Registrational; Therapeutic Use
- Acronyms NEXUS-2
- 23 May 2022 According to a Nymox Pharmaceutical Corporation media release, company has received a Refusal to File (RTF) letter from FDA with regarding the NDA for Fexapotide Triflutate.The letter referred to a new issue of longer-term safety data and indicated that Nymox needed to have longer-term safety data in its NDA. Longer-term full safety data (as long as 6 years after a single low dose non-systemic injection given one time only) was not requested by the FDA in any previous pre-NDA communication.
- 03 Mar 2022 According to a Nymox Pharmaceutical Corporation media release, company has submitted the Company's New Drug Application (NDA) to the FDA for Fexapotide Triflutate to seek marketing approval in the U.S. for Fexapotide Triflutate for the treatment of men with benign prostatic hyperplasia (BPH).
- 22 May 2018 According to a Nymox Pharmaceutical Corporation media release, results from this trial were Presented and Discussed at American Urological Association Annual Meeting 2018.