Drugs / BERSIPOROCIN
BERSIPOROCIN
also known as
DWN12088 · BERSIPOROCIN HYDROCHLORIDE · Bersiporocina · Bersiporocine · DWN-12088 HYDROCHLORIDE
Trials 4
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 13 trials | ||||||
| Phase 1 | NCT04888715 | Jul → Aug 2021 | idiopathic pulmonary fibrosis | Daewoong Pharmaceutical Co. LTD. | Completed | No outcome recorded |
| Phase 1 | NCT04888728 | Jun → Jul 2021 | idiopathic pulmonary fibrosis | Daewoong Pharmaceutical Co. LTD. | Completed | No outcome recorded |
| Phase 1 | NCT04767815 | Mar → May 2021 | idiopathic pulmonary fibrosis | Daewoong Pharmaceutical Co. LTD. | Completed | No outcome recorded |
| Phase 21 trial | ||||||
| Phase 2 | NCT05389215 | Jul 2022 → Oct 2026 expected | idiopathic pulmonary fibrosis | Daewoong Pharmaceutical Co. LTD. | Active not recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 9
| Date | Issuer | Release |
|---|---|---|
| 2026-09-24 | Daewoong Pharmaceutical Co. LTD. | Results Daewoong Pharmaceutical Presents Baseline Characteristics of 104 Patients in Global Phase 2 Trial for IPF Drug Candidate ‘Bersiporocin’ at ERS 2026 daewoong.co.kr ↗
Overall, baseline clinical and functional characteristics were generally similar between patients with and without background antifibrotic therapy. |
| 2026-09-21 | Daewoong Pharmaceutical Co. LTD. | Results 대웅제약 특발성 폐섬유증 신약 ‘베르시포로신’, 유럽호흡기학회서 글로벌 2상 전체 환자 특성 첫 공개 daewoong.co.kr ↗
대웅제약(대표 박성수·이창재)은 지난 6일(현지시간) 스페인 바르셀로나에서 열린 ‘2026 유럽호흡기학회(ERS 2026)’에서 특발성 폐섬유증(Idiopathic Pulmonary Fibrosis, IPF) 치료제 후보물질 ‘베르시포로신(DWN12088)’의 글로벌 임상 2상 전체 등록 환자 104명의 특성 분석 결과에 대한 포스터 발표를 진행했다고 21일 밝혔다. |
| 2025-10-27 | Daewoong Pharmaceutical Co. LTD. | Results Daewoong Pharmaceutical: Third IDMC Reaffirms Safety of Bersiporocin and Recommends Continuation of Global Phase 2 Clinical Trial daewoong.co.kr ↗
The IDMC conducted an in-depth evaluation of interim safety data from 89 enrolled patients and found no significant safety concerns that would impact the trial’s continuation. |
| 2025-06-04 | Daewoong Pharmaceutical Co. LTD. | Results Daewoong Pharmaceutical Presents Phase 2 Clinical Trial Poster on ‘Bersiporocin’ at ATS 2025, Highlights Global Patient Demographics daewoong.co.kr ↗
Daewoong Pharmaceutical (Co-CEOs Seongsoo Park and Chang-Jae Lee) announced that it presented interim results from a global Phase 2 clinical trial of its investigational idiopathic pulmonary fibrosis (IPF) treatment candidate Bersiporocin (DWN12088) at the 2025 American Thoracic Society (ATS) International Conference, held from May 16 to 21 in San Francisco. |
| 2024-07-29 | Daewoong Pharmaceutical Co. LTD. | Results Daewoong Pharmaceutical Receives Positive Recommendation from IDMC to Continue Developing its First-in-Class PRS Inhibitor, Bersiporocin daewoong.co.kr ↗
This latest IDMC meeting involved an in-depth review of the safety data of Bersiporocin, covering 59 enrolled patients, including 51 patients who completed the IPF clinical trial, and found no significant issues. |
| 2024-01-30 | Daewoong Pharmaceutical Co. LTD. | Regulatory Daewoong Pharmaceutical's Bersiporocin Receives ‘Orphan Drug Designation’ in Europe to Treat Idiopathic Pulmonary Fibrosis daewoong.co.kr ↗
This first-in-class PRS inhibitor has recently received ‘Orphan Drug Designation (ODD)’ from the European Medicines Agency (EMA), adding to its earlier designation by the U.S. FDA for both IPF and systemic sclerosis. |
| 2019-08-22 | Daewoong Pharmaceutical Co. LTD. | Regulatory DWN12088, Daewoong Pharmaceutical’s new drug for pulmonary fibrosis, enters global clinical studies phase 1. daewoong.co.kr ↗
It has been announced that DWN12088, the new drug for idiopathic pulmonary fibrosis being developed by Daewoong Pharmaceutical, has been approved for the local clinical studies phase 1 by the Therapeutic Goods Administration (TGA) of Australia on the 21st. |
| 2019-08-19 | Daewoong Pharmaceutical Co. LTD. | Regulatory Daewoong Pharmaceutical’s new drug for pulmonary fibrosis, DWN12088, selected by the U.S. FDA Orphan Drug Designation. daewoong.co.kr ↗
Daewoong Pharmaceutical (CEO Sengho Jeon) announced on the 13th that DWN12088, the world’s first-in-class PRS (Prolyl-tRNA Synthetase) inhibitor for the rare incurable idiopathic pulmonary fibrosis, was selected by the U.S. FDA’s Orphan Drug Designation last 8th. |
| 2018-11-28 | Daewoong Pharmaceutical Co. LTD. | Results Daewoong Pharmaceutical presents its research results on ‘treatments for fibrosis and autoimmune disease’ at ACR daewoong.co.kr ↗
The presentation on DWN12088 comprised of its efficacy on cells and animals with scleroderma and idiopathic pulmonary fibrosis. |
All press releases naming this drug 14 releases
Evidence & citations 9 cited values
Every value below carries the sentence it was read from. 5 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | BERSIPOROCIN | ChEMBL registry synonym — accepted as the source's own label CHEMBL4802138 ↗ |
| Known as | BERSIPOROCIN HYDROCHLORIDE | ChEMBL registry synonym — accepted as the source's own label CHEMBL4802138 ↗ |
| Known as | Bersiporocina | ChEMBL registry synonym — accepted as the source's own label CHEMBL4802138 ↗ |
| Known as | Bersiporocine | ChEMBL registry synonym — accepted as the source's own label CHEMBL4802138 ↗ |
| Known as | DWN-12088 HYDROCHLORIDE | ChEMBL registry synonym — accepted as the source's own label CHEMBL4802138 ↗ |
| Known as | DWN12088 | “Fasting + DWN12088 200 mg” NCT04767815 ↗ |
| Action | Inhibit | “Prolyl-tRNA synthetase (PRS) inhibitor” NCT04888715 ↗ |
| Modality | Small molecule | — CHEMBL4802138 ↗ |
| Route | Oral | “single oral dose of DWN12088” NCT04767815 ↗ |