Drugs / HM30181AK
HM30181AK
also known as
HM30181 · encequidar · HM30181A · HM30181 methanesulfonate · HM30181 methanesulfonate monohydrate
Trials 14
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 111 trials | ||||||
| Phase 1 | NCT07580833 | May → Dec 2026 expected | breast cancer | Health Hope Pharma | Not yet recruiting | No outcome recorded |
| Phase 1 | NCT04993040 | Apr → Dec 2019 | breast carcinoma | Athenex, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT03987685 | Jul 2018 → Jan 2021 | cancer | Athenex, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT02963168 | Apr 2017 → Mar 2020 | cancer | Athenex, Inc. | Unknown | No outcome recorded |
| Phase 1 | NCT02970539 | Dec 2016 → Mar 2019 | esophageal cancer, gastric cancer, gastroesophageal cancer | Athenex, Inc. | Unknown | No outcome recorded |
| Phase 1 | NCT01967043 | Oct 2013 → Feb 2016 | cancer | Kinex Pharmaceuticals Inc. | Completed | No outcome recorded |
| Phase 1 | NCT01463982 | Dec 2010 → Apr 2012 | cancer | Hanmi Pharmaceutical Company Limited | Completed | No outcome recorded |
| Phase 1 | NCT00954304 | Jun → Aug 2009 | — | Hanmi Pharmaceutical Company Limited | Completed | No outcome recorded |
| Phase 1 | NCT00979563 | Jul 2008 → Mar 2010 | high grade malignant neoplasm | Hanmi Pharmaceutical Company Limited | Completed | No outcome recorded |
| Phase 1 | NCT00986843 | Jun 2008 → Feb 2010 | high grade malignant neoplasm | Hanmi Pharmaceutical Company Limited | Completed | No outcome recorded |
| Phase 1 | NCT01491204 | Aug 2006 → Oct 2008 | cancer | Hanmi Pharmaceutical Company Limited | Completed | No outcome recorded |
| Phase 21 trial | ||||||
| Phase 2 | NCT01042379 | Mar 2010 → Dec 2030 expected | HER2 positive breast carcinoma, angiosarcoma, female breast carcinoma, hormone receptor-positive breast cancer +1 | QuantumLeap Healthcare Collaborative | Recruiting | No outcome recorded |
| Phase 32 trials · 1 met primary | ||||||
| Phase 3 | NCT06835400 | Sep 2025 → Apr 2028 expected | breast cancer | Health Hope Pharma | Not yet recruiting | No outcome recorded |
| Phase 3 | NCT02594371 | Dec 2015 → Jul 2019 | breast cancer | Athenex, Inc. | Completed | Met primary |
| Comparator or background therapy4 trials | ||||||
| Phase 1 | NCT03165955 Background | May 2017 → Nov 2018 | breast carcinoma | Health Hope Pharma | Completed | No outcome recorded |
| Phase 1 | NCT02250157 Background | Sep 2014 → Mar 2020 | cancer | Athenex, Inc. | Completed | No outcome recorded |
| Phase 1/2 | NCT01491217 Background | May 2009 → Mar 2012 | gastric cancer | Hanmi Pharmaceutical Company Limited | Unknown | No outcome recorded |
| Phase 2 | NCT04180384 Background | Sep 2015 → Jun 2021 | neoplasm | Athenex, Inc. | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 2
| Date | Issuer | Release |
|---|---|---|
| 2014-11-03 | Hanmi Pharmaceutical Company Limited | Results Hanmi pharmaceuticals and collaborative partner Kinex pharmaceuticals announce preliminary results from a Phase I clinical study (HM-OTE-103) with Oratecan？？ in patients with advanced cancer hanmipharm.com ↗
The MTD of this study was 15mg/m2of irinotecan (as Oratecan) and 1000mg/m2 twice daily of capecitabine. |
| 2014-07-02 | Hanmi Pharmaceutical Company Limited | Results Hanmi pharmaceuticals and collaborative partner Kinex pharmaceuticals report encouraging results on Oraxol for patients with advanced gastric cancer from a phase I/II clinical study hanmipharm.com ↗
43 patients were evaluable for efficacy by RECIST criteria and 21 patients (49%) achieved stable disease or better (duration ranged from 3 to 17 months), including 4 patients (9.3%) who had partial responses (Reduction of tumor burden between 41-52%, duration of partial response 4 - 14 months). |
All press releases naming this drug 2 releases
| Date | Issuer | Release |
|---|---|---|
| 2014-11-03 | Hanmi Pharmaceutical Company Limited | Hanmi pharmaceuticals and collaborative partner Kinex pharmaceuticals announce preliminary results from a Phase I clinical study (HM-OTE-103) with Oratecan？？ in patients with advanced cancer hanmipharm.com ↗ |
| 2014-07-02 | Hanmi Pharmaceutical Company Limited | Hanmi pharmaceuticals and collaborative partner Kinex pharmaceuticals report encouraging results on Oraxol for patients with advanced gastric cancer from a phase I/II clinical study hanmipharm.com ↗ |
Evidence & citations 8 cited values
Every value below carries the sentence it was read from. 18 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | HM30181AK | “Oraxol (Paclitaxel + HM30181AK). Paclitaxel will be supplied as 30 mg capsules and HM30181AK-US will be supplied as 15 mg tablets.” NCT01967043 ↗5“HM30181AK 15 mg tablet + Paclitaxel 10mg, 30mg capsules” NCT01491217 ↗ “HM30181AK Tablet - Fixed dose 15 mg, Day1\~Day5” NCT01463982 ↗ |
| Known as | encequidar | “encequidar (E), a novel P-glycoprotein pump inhibitor, allows oral absorption.” PMID 35858154 ↗ Jul 2022 |
| Known as | HM30181 | “The investigational product (IP) Oratecan is comprised of the approved drug irinotecan with HM30181 methanesulfonate monohydrate (HM30181), a novel p-glycoprotein (P-gp) pump inhibitor.” NCT02250157 ↗4“HM30181 methanesulfonate monohydrate - supplied as 15-mg HM30181AK-US tablets” NCT03165955 ↗ “HM30181 is a drug that helps the body absorb paclitaxel” NCT04180384 ↗ “HM30181 methanesulfonate monohydrate” NCT04993040 ↗ |
| Known as | HM30181 methanesulfonate | “Oraxol is a combination of an oral tablet, HM30181 methanesulfonate, and capsules that contain paclitaxel.” NCT04180384 ↗ |
| Known as | HM30181 methanesulfonate monohydrate | “HM30181 methanesulfonate monohydrate - supplied as 15-mg HM30181AK-US tablets, Paclitaxel - supplied as 30-mg capsules” NCT04993040 ↗ |
| Known as | HM30181A | “Oraxol (Paclitaxel and HM30181A) will be dosed orally. Paclitaxel will be supplied as capsules and HM30181A will be supplied as tablets.” NCT02970539 ↗2“Oral topotecan will be supplied in topotecan capsules and oral HM30181A-US tablets” NCT03987685 ↗ “oral docetaxel + oral HM30181A” NCT02963168 ↗ |
| Action | Inhibit | “HM30181 methanesulfonate monohydrate (HM30181), a novel p-glycoprotein (P-gp) pump inhibitor” NCT02250157 ↗ |
| Route | Oral | “oral administration” NCT00954304 ↗ |