Drugs / HL036
Trials 2
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 21 trial · 1 missed | ||||||
| Phase 2 | NCT03334539 | Nov 2017 → Apr 2018 | dry eye syndrome | HanAll BioPharma Co., Ltd. | Completed | Missed primary |
| Phase 31 trial · 1 missed | ||||||
| Phase 3 | NCT03846453 | Mar → Nov 2019 | dry eye syndrome | HanAll BioPharma Co., Ltd. | Completed | Missed primary |
| Comparator or background therapy1 trial | ||||||
| Phase 1 | NCT02717208 Comparator | Feb → Jun 2016 | dry eye syndrome | HanAll BioPharma Co., Ltd. | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 11
| Date | Issuer | Release |
|---|---|---|
| 2021-07-22 | HanAll BioPharma Co., Ltd. | Regulatory HanAll Biopharma Submits IND for Second Phase 3 (VELOS-3) of HL036 in Dry Eye Disease hanall.com ↗ |
| 2021-02-08 | HanAll BioPharma Co., Ltd. | Regulatory HanAll Biopharma Completes Meeting with FDA for next Phase 3 Trials in Dye Eye Disease hanall.com ↗
FDA stated through the written response that “conducting sign trial(VELOS-3) and symptom trial (VELOS-4) separately for different patient groups“ and “setting the center corneal staining score (CCSS) and the eye dryness score(EDS) as primary endpoints for VELOS-3 and VELOS-4 respectively“ are both acceptable. |
| 2020-11-19 | HanAll BioPharma Co., Ltd. | Results HanAll Biopharma HL036 Clinical Trial Results Selected as Best Poster at AAO 2020 hanall.com ↗
As a result of the Sign clinical trial, the significant improvement effect of HL036 could not be verified through the ICSS(inferior corneal staining score), which was set as the primary endpoint, because it was displayed as p=0.187. |
| 2020-01-28 | HanAll BioPharma Co., Ltd. | Results HanAll Biopharma/Daewoong Announces Topline Results for HL036 Phase 3(VELOS-2) Study at a Press Conference hanall.com ↗
HanAll Biopharma and Daewoong Pharmaceutical announced topline results from the first US Phase 3 study of HL036 for treatment of dry eye(VELOS-2 study) at a press conference on January 21st. |
| 2018-10-29 | HanAll BioPharma Co., Ltd. | Results HanAll Biopharma Announces the Results of HL036’s Phase 2 Clinical Trial at the Ophthalmology Innovation Summit (OIS) in the U.S. hanall.com ↗
At this event, we announced the safety and excellent efficacy of HL036 on inhibition of corneal damage and alleviation of dry eye symptom that were confirmed in the phase 2 clinical trial conducted in the U.S. |
| 2018-10-01 | HanAll BioPharma Co., Ltd. | Regulatory HanAll’s HL036 eye drops for dry eye syndrome treatment was approved of phase 2 clinical trial IND in China hanall.com ↗
HL036(Chinese code: HBM9036), which HanAll BioPharma licensed out to a Chinese company, Harbour Biomed, was approved of phase 2 clinical trial IND in China by the National Medical Products Administration(NMPA) of China. |
| 2018-06-25 | HanAll BioPharma Co., Ltd. | Regulatory HanAll Biopharma’s HL036 was Approved of its International Nonproprietary Name (INN) by the World Health Organization(WHO) hanall.com ↗
HanAll Biopharma(CO-CEO Seung-kook Park and Jae-chun Yun) announced on the 22nd that WHO approved the INN of HL036. |
| 2018-05-29 | HanAll BioPharma Co., Ltd. | Results HanAll Biopharma and Daewoong Pharmaceutical Announced the Result of Phase 2 Clinical Trial of HL036(a new drug for dry eye syndrome) in the U.S. hanall.com ↗
HanAll Biopharma and Daewoong Pharmaceutical today announced the topline results of phase 2 clinical trial in the U.S. of HL036, a new bio drug for dry eye syndrome, which has been jointly developed by them. |
| 2018-05-29 | HanAll BioPharma Co., Ltd. | Results HanAll Biopharma and Daewoong Pharmaceutical Announced the Result of Phase 2 Clinical Trial of HL036(a new drug for dry eye syndrome) in the U.S. hanall.com ↗
HanAll Biopharma and Daewoong Pharmaceutical today announced the topline results of phase 2 clinical trial in the U.S. of HL036, a new bio drug for dry eye syndrome, which has been jointly developed by them. |
| 2015-11-19 | HanAll BioPharma Co., Ltd. | Regulatory HanAll Biopharma, Approved for Clinical Trial Phase 1 of HL036, New Medicine for Dry Eye Disease hanall.com ↗
HanAll Biopharma(CO-CEO Seung-kook Park and Jae-chun Yun) has announced that the company has received the approval for the clinical trial phase 1 on ‘HL036’, the new medicine for dry eye disease, by the Ministry of Food and Drug Safety on November 19. |
| 2015-02-23 | HanAll BioPharma Co., Ltd. | Regulatory HanAll Biopharma, Applied the Clinical Trial Phase 1 for New Medicine of Dry Eye Diseases hanall.com ↗
HanAll Biopharma(CO-CEO Seong-uk Kim and Seung-kook Park) has announced that the company has submitted the application for the approval of clinical trial phase 1 clinical study plan of investigational new drug (IND) on new medicine ‘HL036’ of dry eye disease to the Ministry of Food and Drug Safety on February 23. |
All press releases naming this drug 13 releases
Evidence & citations 2 cited values
Every value below carries the sentence it was read from. 3 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | HL036 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT02717208 ↗ |
| Route | Topical | “as topical ophthalmic drops” NCT03334539 ↗ |