Drugs / Pelubiprofen

Trials 9

PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 15 trials
Phase 1 NCT07032558 Sep 2025 overdue — Haiphong University of Medicine and Pharmacy Recruiting No outcome recorded
Phase 1 NCT07060209 Sep → Oct 2025 overdue — Haiphong University of Medicine and Pharmacy Recruiting No outcome recorded
Phase 1 NCT05214677 Aug → Sep 2020 osteoarthritis, respiratory tract infectious disorder, rheumatoid arthritis Daewon Pharmaceutical Co., Ltd. Completed No outcome recorded
Phase 1 NCT05214690 Aug → Sep 2020 osteoarthritis, respiratory tract infectious disorder, rheumatoid arthritis Daewon Pharmaceutical Co., Ltd. Completed No outcome recorded
Phase 1 NCT01776697 Mar → Apr 2012 — Daewon Pharmaceutical Co., Ltd. Completed No outcome recorded
Phase 34 trials · 2 met primary
Phase 3 NCT04541134 Sep 2020 → Aug 2021 primary dysmenorrhea Daewon Pharmaceutical Co., Ltd. Unknown No outcome recorded
Phase 3 NCT03874247 Feb → Dec 2019 — Daewon Pharmaceutical Co., Ltd. Unknown No outcome recorded
Phase 3 NCT01779271 Jan 2013 → Mar 2016 respiratory tract infectious disorder Daewon Pharmaceutical Co., Ltd. Completed Met primary
Phase 3 NCT01781702 Oct 2010 → Oct 2011 rheumatoid arthritis Daewon Pharmaceutical Co., Ltd. Completed Met primary
Comparator or background therapy4 trials
Phase 1 NCT01870102 Comparator ? → Aug 2013 — Daewon Pharmaceutical Co., Ltd. Completed No outcome recorded
Phase 2 NCT03424707 Comparator Mar → Aug 2016 — Daewon Pharmaceutical Co., Ltd. Completed No outcome recorded
Phase 3 NCT02375633 Comparator Apr → Nov 2014 chronic pain syndrome Daewon Pharmaceutical Co., Ltd. Completed No outcome recorded
Phase 4 NCT02682524 Comparator Aug 2015 → Mar 2016 osteoarthritis, knee Daewon Pharmaceutical Co., Ltd. Completed No outcome recorded

News releases announcing trial results or a regulatory action · 1

DateIssuerRelease
2026-10-08 Daewon Pharmaceutical Co., Ltd. Results 대원제약, KOA 2026서 ‘펠루비’ 수술 후 통증 조절 신규 연구 발표 daewonpharm.com ↗
두 군 간 차이는 0.2mm(95% 신뢰구간 -4.4~4.8mm)로, 신뢰구간 상한이 사전에 설정한 비열등성 한계인 10mm를 넘지 않아 펠루비프로펜의 통증 조절 효과가 셀레콕시브 대비 비열등한 것으로 확인됐다.

All press releases naming this drug 1 release

DateIssuerRelease

Evidence & citations 14 cited values

Every value below carries the sentence it was read from. 15 sources stand behind the page.

FieldValueCited text
Known as Pelubiprofen “DW-1021 is a fixed-dose combination tablet containing Pelubiprofen 45 mg and Tramadol 45.9 mg (as a salt), formulated as a controlled-release film-coated tablet.” NCT07032558 ↗
12

“A fixed-dose combination controlled release film-coated tablet containing pelubiprofen 45 mg and tramadol 45.9 mg (salt form)” NCT07060209 ↗

“pelubiprofen 30mg (PELUBI tab.)” NCT05214677 ↗

“pelubiprofen 25mg” NCT05214690 ↗

NCT01781702 ↗

NCT01776697 ↗

NCT03424707 ↗

NCT02682524 ↗

NCT02375633 ↗

NCT01779271 ↗

NCT04541134 ↗

Show 2 more sources

Known as 2-[4-(oxocyclohexylidenemethyl)-phenyl]propionic acid “Anti-inflammatory effect of pelubiprofen, 2-[4-(oxocyclohexylidenemethyl)-phenyl]propionic acid, mediated by dual suppression of COX activity and LPS-induced inflammatory gene...” PMID 21809372 ↗ Dec 2011
Known as CS-670 ChEMBL registry synonym — accepted as the source's own label CHEMBL69308 ↗
Known as Pelubi “Pelubi(pelubiprofen)” NCT03424707 ↗
Known as Pelubi CR “The reference treatment consists of two separate controlled-release film-coated tablets: Pelubi CR (Pelubiprofen 45 mg) and Zytram CR (Tramadol HCl 75 mg).” NCT07032558 ↗
Known as PELUBI tab. “pelubiprofen 30mg (PELUBI tab.)” NCT05214690 ↗
1

“pelubiprofen 30mg (PELUBI tab.)” NCT05214677 ↗

Known as Pelubiprofen IR “Pelubiprofen IR (Pelubiprofen 30mg) TID” NCT01870102 ↗
Known as Pelubiprofen SR “Pelubiprofen SR (Pelubiprofen 45 mg) BID” NCT01870102 ↗
Known as Pelubiprofene ChEMBL registry synonym — accepted as the source's own label CHEMBL69308 ↗
Known as Pelubiprofeno ChEMBL registry synonym — accepted as the source's own label CHEMBL69308 ↗
Known as RS-2131 ChEMBL registry synonym — accepted as the source's own label CHEMBL69308 ↗
Action Inhibit “pelubiprofen potently diminished PGE(2) productions through inhibition of COX enzyme activity” PMID 21809372 ↗ Dec 2011
Modality Small molecule — CHEMBL69308 ↗
Route Oral “It is administered as a single oral dose with 150 mL of water under fasting conditions for the evaluation of pharmacokinetics in healthy adult male volunteers.” NCT07032558 ↗