Drugs / Antroquinonol
Trials 9
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial | ||||||
| Phase 1 | NCT01134016 | Dec 2010 → Jun 2013 | non-small cell lung carcinoma | Golden Biotechnology Corporation | Completed | No outcome recorded |
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT03310632 | Dec 2017 → Dec 2023 | pancreatic neoplasm | Golden Biotechnology Corporation | Completed | No outcome recorded |
| Phase 27 trials | ||||||
| Phase 2 | NCT03823352 | Feb 2019 → Dec 2020 | acute myeloid leukemia | Golden Biotechnology Corporation | Completed | No outcome recorded |
| Phase 2 | NCT04112147 | Aug 2018 → Jun 2020 | chronic hepatitis B virus infection | Cheng-Chung Wei | Unknown | No outcome recorded |
| Phase 2 | NCT03625102 | Aug 2018 → Jun 2023 | chronic hepatitis B virus infection | Golden Biotechnology Corporation | Completed | No outcome recorded |
| Phase 2 | NCT04110873 | Jul 2018 → Jun 2019 | atopic eczema | Chung Shan Medical University | Terminated | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT03622463 | Jul 2018 → Jul 2019 | atopic eczema | Golden Biotechnology Corporation | Completed | No outcome recorded |
| Phase 2 | NCT02719028 | May 2016 → Sep 2018 | hyperlipidemia | Golden Biotechnology Corporation | Completed | No outcome recorded |
| Phase 2 | NCT02047344 | Oct 2013 → Dec 2018 | non-small cell lung carcinoma | Golden Biotechnology Corporation | Completed | No outcome recorded |
| Comparator or background therapy1 trial | ||||||
| Phase 2 | NCT04523181 Comparator | Oct 2020 → Dec 2021 | COVID-19 | Golden Biotechnology Corporation | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 10
| Date | Issuer | Release |
|---|---|---|
| 2026-02-09 | Golden Biotechnology Corporation | Regulatory Golden Biotech Announces IND May Proceed with Phase III Trial of Antroquinonol (Hocena) in First-Line Metastatic Pancreatic Cancer goldenbiotech.com ↗
The US FDA has reviewed the submission and issued no Clinical Hold, clearing the path for trial initiation |
| 2025-12-31 | Golden Biotechnology Corporation | Regulatory Dec 31, 2025 Golden Biotech Receives CRO Notification of FDA Acceptance of Phase III IND Application for Antroquinonol (Hocena) in Metastatic Pancreatic Cancer goldenbiotech.com ↗
Golden Biotechnology Corp. (TPEx 4132) ("GoldenBiotech", GBC) announced that it has received notification from its contract research organization (CRO) that the Investigational New Drug (IND) application for the small-molecule drug Antroquinonol (Hocena) has been submitted to and accepted by the U.S. Food and Drug Administration (FDA) for review. |
| 2024-01-19 | Golden Biotechnology Corporation | Results ASCO GI 2024: Golden Biotech's Antroquinonol Shows Significantly Prolonged Survival in Untreated Metastatic Pancreatic Cancer Patients (Yahoo Finance) goldenbiotech.com ↗
The trial showed a positive median overall survival (mOS) of 14.1 months, which is a substantial increase compared to 8.5 months mOS observed in the standard of care Phase III clinical study (nab-paclitaxel + gemcitabine). |
| 2023-05-08 | Golden Biotechnology Corporation | Results Golden Biotech Announces Positive Results with Longer Survival Compared with Standard Treatments from Interim Analysis of Phase 2 Trial for Antroquinonol as 1st Line Treatment for Stage 4 Metastatic Pancreatic Cancer goldenbiotech.com ↗
Golden Biotechnology Corp. (TPEX 4132) ("GoldenBiotech", GBC), an advanced biopharmaceutical drug development company, announces the release of positive interim results from its Phase II clinical trial of Antroquinonol (HOCENA®) in combination with the standard of care (SOC) nab-paclitaxel + gemcitabine for first-line treatment of metastatic pancreatic cancer. |
| 2022-07-07 | Golden Biotechnology Corporation | Regulatory GoldenBiotech Received FDA AoR of its Pre-EUA Meeting Request for COVID-19 Trial Drug Antroquinonol goldenbiotech.com ↗
This Pre-EUA Meeting Request is for the application of the new drug Antroquinonol which completed the clinical trial (IND149841) targeting to hospitalized patients with mild to moderate Covid-19 pneumonia. |
| 2022-05-27 | Golden Biotechnology Corporation | Regulatory FDA Approves GoldenBiotech's IND Application of Antroquinonol for Phase II Trial on Relapsed Acute Myeloid Leukemia (AML) goldenbiotech.com ↗
On May 27, 2022, Golden Biotechnology Corp. received a letter of approval via CRO from the US Food and Drug Administration (US FDA) with IND NO: 157917. |
| 2021-08-30 | Golden Biotechnology Corporation | Regulatory GoldenBiotech’s Oral COVID-19 New Drug Trial of Antroquinonol Got Green Light from the FDA to Extend Recruiting Severe COVID-19 Patients goldenbiotech.com ↗ |
| 2021-07-02 | Golden Biotechnology Corporation | Regulatory GoldenBiotech HOCENA Granted Compassionate Use by the TFDA for Treatment of Covid-19 Patients goldenbiotech.com ↗
Golden Biotechnology Corp.(TPEx:4132) (“GoldenBiotech”, GBC), a leading Taiwanese biopharmaceutical company, announces that its investigational new drug HOCENA(antroquinonol) has been granted the ” Compassionate Use ” on July 1st by Taiwan FDA to be used in the treatment of mild to moderate Covid-19 patients in the applied hospital. |
| 2021-06-03 | Golden Biotechnology Corporation | Results Covid-19 Trial_GoldenBiotech New Drug Antroquinonol Passed 2nd DMC Review in the USA goldenbiotech.com ↗
Golden Biotechnology Corp.(TPEx:4132)(“GoldenBiotech”, GBC), a leading Taiwanese biopharmaceutical company, announces that its investigational new drug HOCENA(antroquinonol) has passed the second DMC review in the USA |
| 2021-04-07 | Golden Biotechnology Corporation | Results GoldenBiotech Presents Outstanding Results of Potential Treatment for Relapsed AML in ASCO 2021 goldenbiotech.com ↗
Here, the results from our phase IIa trial demonstrate the safety, tolerability, and activity of Antroquinonol in patients with relapsed AML. |
All press releases naming this drug 13 releases
Evidence & citations 8 cited values
Every value below carries the sentence it was read from. 11 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Antroquinonol | ClinicalTrials.gov intervention name — accepted as the source's own label NCT03823352 ↗ |
| Known as | Antroquinonol a | ChEMBL registry synonym — accepted as the source's own label CHEMBL3235620 ↗ |
| Known as | Hocena | “Antroquinonol (Hocena) 50mg/capsule.” NCT03625102 ↗ |
| Known as | J3.387.174K | ChEMBL registry synonym — accepted as the source's own label CHEMBL3235620 ↗ |
| Action | Inhibit | “antroquinonol (a cytochrome P450 [CYP]3A4/CYP2C8 inhibitor)” NCT03310632 ↗ |
| Modality | Small molecule | “Antroquinonol, a novel cyclohexenone compound, is a purified compound from extract of Antrodia camphorata.” NCT01134016 ↗ |
| Route | Oral | “Antroquinonol was taken orally” NCT01134016 ↗ |
| Target | CYP2C8 | “antroquinonol (a cytochrome P450 [CYP]3A4/CYP2C8 inhibitor)” NCT03310632 ↗ |