Drugs / FG001
Trials 2
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 2 | NCT07609472 | Jun 2026 → Jul 2028 expected | high grade astrocytic tumor | FluoGuide A/S | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT06684795 | May 2024 → Jun 2026 | low grade glioma, meningioma | Rigshospitalet, Denmark | Unknown | No outcome recorded |
News releases announcing trial results or a regulatory action · 37
| Date | Issuer | Release |
|---|---|---|
| 2026-06-29 | FluoGuide A/S | Results FluoGuide announces positive results from Phase 2 oral head and neck cancer trial fluoguide.com ↗
FluoGuide A/S (“FluoGuide” or the “Company”), a biotech company maximizing surgical outcomes in oncology by lighting up cancer, today announced positive results from the first part of its ongoing FG001-CT-005 Phase 2 trial evaluating FG001 for surgical guidance in patients with oral head and neck cancer. |
| 2026-04-10 | FluoGuide A/S | Results Positive interim results from an investigator-initiated study of FG001 in meningioma and low-grade glioma surgery, re-presented at SNOG fluoguide.com ↗
The interim data from the investigator-initiated clinical study of FG001 used in surgery of patients with meningioma and presumed low grade glioma (pLGG) have precisely been presented at international conferences: |
| 2026-03-18 | FluoGuide A/S | Regulatory FluoGuide receives FDA Fast Track Designation for FG001 in high-grade glioma fluoguide.com ↗
FluoGuide A/S (“FluoGuide” or the “Company”), a biotech company maximizing surgical outcomes in oncology by lighting up cancer, announces that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to FG001 as an intraoperative imaging agent to guide surgical resection of high-grade glioma. |
| 2026-02-20 | FluoGuide A/S | Regulatory FDA clears FluoGuide’s IND for FG001 in High-Grade Glioma; U.S. clinical trial remains on track fluoguide.com ↗
the U.S. Food and Drug Administration (FDA) has informed the Company that it can proceed with the proposed clinical investigation for FG001. |
| 2026-01-21 | FluoGuide A/S | Regulatory FluoGuide submits an IND for FG001, to initiate first U.S. registration trial fluoguide.com ↗
FluoGuide A/S (“FluoGuide” or the “Company”), a biotech company maximizing surgical outcomes in oncology by lighting up cancer, today announced that it has submitted an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) for FG001. |
| 2025-10-06 | FluoGuide A/S | Results Positive interim results from an investigator-initiated study of FG001 in meningioma and low-grade glioma surgery, presented at EANS fluoguide.com ↗
The interim analysis included 10 patients with meningioma. |
| 2025-09-16 | FluoGuide A/S | Regulatory FluoGuide receives positive FDA feedback on FG001 in high-grade glioma fluoguide.com ↗
FluoGuide received FDA alignment on its U.S. high-grade glioma (HGG) Phase 2 clinical trial design and key elements of its future Phase 3 clinical program. |
| 2025-06-10 | FluoGuide A/S | Results FG001 clinical data in High-Grade Glioma is now published in Neurosurgery fluoguide.com ↗
FluoGuide A/S ("FluoGuide" or the "Company"), a clinical-stage biotech company focused on precision cancer surgery, is pleased to announce its compelling phase I clinical data with FG001 has been published in Neurosurgery. |
| 2025-01-15 | FluoGuide A/S | Regulatory FluoGuide A/S receives approval for phase II trial in head and neck cancer fluoguide.com ↗
The Phase II Clinical Trial Application (CTA) for FG001 in head and neck cancer, announced on October 7, 2024, has been granted approval under the new European process by the Dutch Central Committee on Research Involving Human Subjects and the Medical Ethical Committee of the University Medical Center Groningen. |
| 2024-11-19 | FluoGuide A/S | Results Publication of positive phase II clinical data for FG001 in patients with head and neck cancer fluoguide.com ↗
The trial included 16 patients diagnosed with oral or oropharyngeal squamous cell carcinoma undergoing surgery |
| 2024-10-07 | FluoGuide A/S | Regulatory FluoGuide A/S submits Clinical Trial Application for phase II trial in head and neck cancer fluoguide.com ↗
FluoGuide A/S (“FluoGuide” or the “Company”), a biothech company specializing in precision cancer surgery, today announced the submission of the Clinical Trial Application (CTA) for phase II trial in head and neck cancer (oral squamous cell carcinoma cancer). |
| 2023-11-13 | FluoGuide A/S | Results FluoGuide announces FG001 meets primary endpoint in phase llb trial in aggressive brain cancer fluoguide.com ↗
FluoGuide A/S (“FluoGuide” or the “Company”), a pioneer in the cutting-edge field of precision cancer surgery, today announced positive topline efficacy and safety results in the phase IIb trial with the lead product FG001 for guiding surgery in aggressive brain cancer (high-grade glioma). |
| 2023-11-06 | FluoGuide A/S | Results FluoGuide confirms positive topline results from phase lla trial of FG001 in head & neck cancer at International Academy of Oral Oncology conference fluoguide.com ↗
These encouraging first clinical results, showing that FG001 was able to light up cancer in all head & neck cancer patients in the trial, indicate it could make a significant difference for operating surgeons and their patients. |
| 2023-10-03 | FluoGuide A/S | Regulatory FluoGuide receives FDA Orphan Drug Designation for FG001 in high-grade glioma fluoguide.com ↗
The FDA's Office of Orphan Products Development grants orphan drug designation to FG001 to support the development of this diagnostic agent for the management of malignant glioma as a rare disorder affecting fewer than 200,000 people in the U.S. |
| 2023-09-07 | FluoGuide A/S | Results Positive interim data from phase lla trial of FG001 in head & neck cancer presented as a case report at the World Molecular Imaging Congress in Prague fluoguide.com ↗
The presentation contains a patient case. |
| 2023-08-29 | FluoGuide A/S | Results FluoGuide reports further positive interim data from phase IIa trial of FG001 in head & neck cancer fluoguide.com ↗
Data show that cancer lit up in all 16 patients treated in the trial so far, including those receiving a low dose of FG001. |
| 2023-06-20 | FluoGuide A/S | Results FluoGuide announces positive interim results from phase IIa trial of FG001 in head & neck cancer fluoguide.com ↗
FG001 was shown to illuminate tumors in all of the patients. |
| 2023-06-07 | FluoGuide A/S | Results FluoGuide announces positive topline results from phase IIa trial of FG001 in lung cancer fluoguide.com ↗ |
| 2023-05-24 | FluoGuide A/S | Results FluoGuide provides update on strong clinical trial progress fluoguide.com ↗
Interim results from the phase IIa trial in lung cancer demonstrate consistent activity of FG001 with light detected in 6 out of 8 patients. |
| 2023-01-09 | FluoGuide A/S | Results FluoGuide releases positive interim result of FG001 in head and neck cancer fluoguide.com ↗
FluoGuide A/S ("FluoGuide" or the "Company") is pleased to announce the positive interim result of FG001 in head and neck cancer that FG001 lights up in 4 out of 4 patients following the interim evaluation of the first four patients dosed in the ongoing explorative phase IIa trial in patients with head and neck squamous cell carcinomas (HNSCC) undergoing surgery. |
| 2022-11-06 | FluoGuide A/S | Results FluoGuide releases positive interim result of FG001-CT002, a phase IIa trial evaluating FG001 in patients with non-small cell lung cancer (NSCLC) undergoing surgery fluoguide.com ↗
FluoGuide A/S (“FluoGuide” or the “Company”) is pleased to announce that FG001 lights up in 5 out of 7 patients in an interim evaluation in the ongoing phase IIa trial in non-small cell lung cancer (NSCLC) |
| 2022-10-03 | FluoGuide A/S | Results The excellent phase I/IIa clinical data of FG001 in aggressive brain cancer was presented at the World Molecular Imaging Congress fluoguide.com ↗ |
| 2022-08-30 | FluoGuide A/S | Regulatory FluoGuide receives permission to start phase IIb trial in aggressive brain cancer fluoguide.com ↗
FluoGuide A/S (“FluoGuide” or the “Company”) is pleased to announce that the company now has received the permission to start the phase IIb clinical trial with FG001. |
| 2022-04-01 | FluoGuide A/S | Results FluoGuide announces positive top line result from the first part of the ongoing clinical phase I/II trial testing the safety and performance of FG001 in lightening up aggressive brain cancer fluoguide.com ↗
The early evidence of efficacy has been demonstrated by strong illumination of brain tumors and histology data has now confirmed that the tissue lighted up is cancer. |
| 2021-11-09 | FluoGuide A/S | Results Publication of a case report showing first promising clinical data on FG001s use in treatment of meningioma brain tumor fluoguide.com ↗
The case report indicates that FG001 may be used in other types of brain tumors than High Grade Glioma and thereby opens new opportunities for the realization of clinical and commercial potential of FG001 |
| 2021-10-08 | FluoGuide A/S | Results FG001 is proven safe in patients undergoing surgery for cancer – a significant milestone for FluoGuide to further advance clinical development in aggressive brain cancer and in a prevalent indication fluoguide.com ↗
FluoGuide A/S (“FluoGuide” or the “Company”) is pleased to announce that FG001 has been concluded to be safe and well tolerated by the dose escalation committee monitoring the ongoing phase I/II clinical trial. |
| 2021-09-14 | FluoGuide A/S | Results FluoGuide proceeds to seventh dose level (36 mg) with FG001 in the ongoing clinical phase I/II trial following continued improvement of tumor illumination with increasing doses fluoguide.com ↗
The data from the sixth dose (24 mg) showed a continued improvement and clear illumination of the tumors in all three patients. |
| 2021-08-26 | FluoGuide A/S | Regulatory FluoGuide announces regulatory approval from Swedish Authorities (MPA and Ethics committee) to commence Phase II clinical trial with FG001 in guiding surgery of high grade glioma in Sweden fluoguide.com ↗
FluoGuide A/S (“FluoGuide” or “the Company”) is pleased to announce that the company has received regulatory approval for expanding the ongoing clinical phase I/II trial to Sweden with FG001. |
| 2021-08-23 | FluoGuide A/S | Results Publication of promising preclinical data on FG001s effect in treatment of cancer fluoguide.com ↗
FluoGuide A/S ("FluoGuide" or the “Company”) is pleased to announce the first publication of preclinical data where the Company’s compound FG001 is used as a photothermal therapy agent for treatment of cancer. |
| 2021-08-17 | FluoGuide A/S | Results FluoGuide proceeds to sixth dose level with FG001 in the ongoing clinical phase I/II trial following strong data from the concluded evening dosing fluoguide.com ↗
FluoGuide A/S (“FluoGuide” or the “Company”) is pleased to report that FG001 was well tolerated, and light was detected in all patients, as anticipated, in the fifth cohort (16 mg) administered the evening before surgery. |
| 2021-05-12 | FluoGuide A/S | Regulatory FluoGuide has received approval to commence with FG001 in evening dosing in the ongoing clinical phase I/II trial in patients with high grade glioma fluoguide.com ↗
FluoGuide A/S (“FluoGuide” or the “Company”) is pleased to announce that the Danish Medicines Agency and Ethical Committee has approved administration of FG001 in the evening before surgery. |
| 2020-09-03 | FluoGuide A/S | Regulatory FluoGuide announces regulatory approval from Danish Medicines Agency to commence Phase I/II clinical trial with FG001 in guiding surgery of high grade glioma including glioblastoma fluoguide.com ↗
FluoGuide A/S (“FluoGuide” or “the Company”) is pleased to announce that the company has received regulatory approval for the first clinical phase I/II trial. |
| 2020-07-06 | FluoGuide A/S | Regulatory FluoGuide A/S submits phase I/II Clinical Trial Application fluoguide.com ↗
FluoGuide A/S (“FluoGuide” or “the Company”) today submitted a Clinical Trial Application for the proof-of-concept clinical phase I/II trial of FG001 for use in guiding surgery of aggressive brain cancer (glioblastoma). |
| 2020-01-15 | FluoGuide A/S | Results Excellent result of FluoGuide’s FG001 guiding surgical removal of cancer is published fluoguide.com ↗
FluoGuide can announce that data which confirms FG001’s potential in guiding surgical removal of pancreatic cancer has now also been published in peer reviewed journal. |
| 2019-09-07 | FluoGuide A/S | Results Presentation of data where FG001 demonstrates dose-depended effectiveness in lightening up glioblastoma in a preclinical model fluoguide.com ↗
Today data was presented at World Molecular Imaging Congress 2019 (WMIC) in Montreal, demonstrating dose-dependent FG001 effectiveness in lightening up glioblastoma in a preclinical model. |
| 2019-09-06 | FluoGuide A/S | Results Presentation of data where use of FG001 demonstrates improved surgical outcome in metastatic pancreatic cancer compared to standard surgery using only white light fluoguide.com ↗
Today data was presented at World Molecular Imaging Congress 2019 (WMIC) in Montreal, demonstrating how FG001 for in vivo fluorescent guidance improved surgical resection of metastatic pancreatic cancer in comparison with traditional white light surgery. |
| 2019-08-12 | FluoGuide A/S | Results FG001 again demonstrates strong data in guiding glioblastoma surgery – accepted for presentation at the World Molecular Imaging Congress 2019 fluoguide.com ↗
FluoGuide A/S ("FluoGuide") today announces that new data confirms FG001’s potential in guiding surgical removal of glioblastoma. |
All press releases naming this drug 70 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 | FG001 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT06684795 ↗ |
| Known as | ICG-Glu-Glu-AE105 | “The drug FG001 (ICG-Glu-Glu-AE105), a uPAR-targeting fluorescent drug, has been tested in patients with high-grade glioma as part of a First-in-human clinical trial and...” NCT06684795 ↗ |
| Modality | Diagnostic / imaging agent | “FG001 (an Optical Imaging Agent)” NCT06684795 ↗ |
| Route | Intravenous | “single intravenous injection” NCT06684795 ↗ |