Drugs / D07001
D07001
Trials 2
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 2/31 trial | ||||||
| Phase 2/3 | NCT05065957 | Mar 2022 → Jul 2026 overdue | biliary tract cancer | InnoPharmax Inc. | Recruiting | No outcome recorded |
| Phase 31 trial | ||||||
| Phase 3 | NCT06622057 | Jun 2026 → Dec 2028 expected | biliary tract cancer | InnoPharmax Inc. | Recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 9
| Date | Issuer | Release |
|---|---|---|
| 2026-01-05 | InnoPharmax Inc. | Regulatory InnoPharmax Submits Phase II Trial Application for D07001 (GemOral) to TFDA. innopharmax.com ↗
The Company has submitted a new Phase II clinical trial application for its self-developed D07001 soft capsule to the Taiwan Food and Drug Administration (TFDA). |
| 2025-04-10 | InnoPharmax Inc. | Results Completion of Stage 1 in the Phase II/III Clinical Trial of D07001 Softgel Capsules for Advanced Biliary Tract Cancer. innopharmax.com ↗
Data indicate that D07001 softgel capsules, at the maximum tolerated dose (MTD), can be safely combined with Xeloda or TS-1, supporting dose selection for subsequent studies. |
| 2024-12-10 | InnoPharmax Inc. | Regulatory InnoPharmax Advances D07001 to Phase III for Cholangiocarcinoma. innopharmax.com ↗
Therefore, the Company is permitted to proceed with the Phase III clinical trial. |
| 2024-11-08 | InnoPharmax Inc. | Regulatory InnoPharmax Submits Phase III Trial Application for D07001 to US FDA. innopharmax.com ↗
The Company has submitted an application to the U.S. Food and Drug Administration (US FDA) to conduct a Phase III (pivotal) clinical trial for its investigational orphan drug, D07001, indicated for the treatment of cholangiocarcinoma. |
| 2024-06-21 | InnoPharmax Inc. | Regulatory Orphan drug designated D07001 heading to global phase 3 pivotal study. innopharmax.com ↗
On May 31, 2024, Innopharmax obtained US FDA preliminary go-ahead for the IND application of phase 3 clinical trial of new drug D07001, for the indication in late stage Biliary Tract Cancer (BTC). |
| 2021-10-04 | InnoPharmax Inc. | Regulatory D07001 (GemOral) Phase II/III clinical trial in humans for advanced bile duct cancer (Project No. INNO-GO-05) has been approved innopharmax.com ↗
D07001 (GemOral) Phase II/III clinical trial in humans for advanced bile duct cancer (Project No. INNO-GO-05) has been approved by Taiwan Food and Drug Administration (TFDA). |
| 2020-07-10 | InnoPharmax Inc. | Results D07001 phase Ib/II clinical trial for anti-cancer treatment has completed and the result are as expected. innopharmax.com ↗
D07001 phase Ib/II clinical trial for anti-cancer treatment has completed and the result are as expected. |
| 2016-01-27 | InnoPharmax Inc. | Regulatory InnoPharmax Receives FDA Orphan Drug Designation for Gemcitabine in the Treatment of Cholangiocarcinoma innopharmax.com ↗
InnoPharmax Inc. announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation to gemcitabine for the treatment of cholangiocarcinoma. |
| 2011-09-19 | InnoPharmax Inc. | Regulatory InnoPharmax Inc. Receives US FDA IND Approval to Begin Clinical Trials of Gemcitabine Hydrochloride Oral Formulation innopharmax.com ↗
InnoPharmax Inc. announced that the U.S. Food and Drug Administration (FDA) approved its Investigational New Drug (IND) application for Gemcitabine Hydrochloride Oral Formulation (D07001-F4). |
All press releases naming this drug 17 releases
Evidence & citations 4 cited values
Every value below carries the sentence it was read from. 2 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | D07001 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT06622057 ↗ |
| Known as | D07001-softgel capsules | “D07001-softgel capsules: 3 times per week (on Days 1, 3, 5, 8, 10, 12, 15, 17, and 19 of a 21-day cycle, 9 doses per cycle).” NCT05065957 ↗ |
| Known as | gemcitabine | “D07001-softgel capsule is an oral gemcitabine.” NCT06622057 ↗ |
| Route | Oral | “eligible patients will be assigned to receive oral D07001-softgel” NCT05065957 ↗ |