An open-label, single dose, dose finding, exploratory phase II trial of FG001 (an optical imaging agent) for intraoperative visualization of inadequate margins in subjects with oral squamous cell carcinoma.

开始日期2025-04-14

申办/合作机构

FluoGuide A/S

NCT06684795

/ Recruiting临床2期IIT

An Open-label, Non-randomized, Single Dose, Phase II Trial of FG001 (an Optical Imaging Agent) for Localization of Meningiomas or Presumed Low-Grade Gliomas Scheduled for Neurosurgery

In neurosurgery both the diffusely infiltrated gliomas of the brain as well as the border towards healthy tissue in the meninges is a challenge. For the high-grade contrast enhanced gliomas fluorescent drugs like Gliolan have been used in several years and proved its clinical value. For non-contrast enhanced gliomas, like low-grade glioma, no such drug exist. The transition zone towards healthy non-tumor cell infiltrated brain in such low-grade gliomas is extremely difficult but for these patients their prognosis depends on the amount of non-healthy tissue left behind. Also, in benign tumors as meningioma the complete resection including infiltrated meninges is of importance for the cure of the disease. None of the existing fluorescent drug is useful or approved for these tumors.. Hence a medicinal product that will fulfil the criteria for a safe and reliable fluorescent drug to guide the surgery to the boundaries of the infiltration with tumor cells is highly warranted.

开始日期2024-05-01

申办/合作机构

Rigshospitalet

100 项与 FG-001 相关的临床结果

登录后查看更多信息

100 项与 FG-001 相关的转化医学

登录后查看更多信息

100 项与 FG-001 相关的专利（医药）

登录后查看更多信息

项与 FG-001 相关的文献（医药）

2025-12-01·NEUROSURGERY

Novel Urokinase-Type Plasminogen Activator Receptor-Targeting Optical Imaging Agent ICG-Glu-Glu-AE105 for Visualization of Malignant Glioma During Surgery: First-in-Human Study in 35 Patients with Brain Cancer

Article

作者: Skjøth-Rasmussen, Jane ; Sølling, Christine ; Kryspin Sørensen, Martin ; Ginsborg, Sara ; Kjaer, Andreas ; Azam, Aleena ; Scheie, David ; Winther Kristensen, Bjarne ; Juhl, Karina ; Larsen, Carl Christian

BACKGROUND AND OBJECTIVES::

Glioblastoma is an aggressive form of brain cancer for which surgery is the keystone in treatment before oncological treatment. Improving surgical resection without jeopardizing the outcome is eminent, and a fluorescent drug to aid surgical outcome is warranted. To evaluate the safety and the efficacy of a novel urokinase-type Plasminogen Activator Receptor-targeting near-infrared optical imaging agent, ICG-Glu-Glu-AE105 (FG001), in patients with malignant glioma (glioblastoma).

METHODS::

First-in-human phase I dose escalation and time elaboration study in 35 patients undergoing surgery for glioblastoma. The tumor-to-background ratio (TBR) was measured on near-infrared images as an objective measure of image contrast. Biopsies were taken during surgery from areas with and without fluorescence (FG001) and compared with pathology as reference. Efficacy was evaluated as sensitivity and specificity of FG001 to detect tumor tissue. The study was conducted with close safety monitoring.

RESULTS::

Administration of FG001 at a dose of 36 mg, 12 to 17 hours before surgery, resulted in optimal image contrast between tumor and normal brain tissue, with a mean TBR of 3.6. A high sensitivity (79%) and specificity (100%) for the detection of tumor tissue was found. Safety monitoring during the study identified only a few related adverse events, all of which were of mild grade.

CONCLUSION::

FG001 was found to be safe and well tolerated in the patients included in the study. The optimal dose of FG001 was selected on the basis of videos taken during the surgery and the measured TBR values. A dose of 36 mg administered 16 hours (mean) before the surgery showed the best contrast (TBR values) and optimal visualization of the tumor delineation. Histology demonstrated good sensitivity of FG001.

2025-08-02·ChemMedChem

Novel 4,5‐Dihydrothiazole‐Phenylpiperazine Derivatives: Synthesis, Docking Studies and Pharmacological Evaluation as Serotonergic Agents

Article

作者: Santagada, Vincenzo ; Sparaco, Rosa ; Kędzierska, Ewa ; Capasso, Raffaele ; Corvino, Angela ; Gawel, Kinga ; Gibuła‐Tarłowska, Ewa ; Caliendo, Giuseppe ; Lesniak, Anna ; Magli, Elisa ; Kaczor, Agnieszka A. ; Karkoszka, Natalia ; Biała, Grażyna ; Bielenica, Anna ; Severino, Beatrice ; Andreozzi, Giorgia ; Kotlińska, Jolanta H. ; Fiorino, Ferdinando ; Semenko, Nataliia

The synthesis of a new series of long‐chain arylpiperazine as serotoninergic ligands (FG 1‐18) is described. The combination of structural elements including heterocyclic nucleus, propyl chain, and 4,5‐dihydrothiazol‐2‐ylphenylpiperazines leads to the preparation of different derivatives tested for their affinity toward 5‐HT1A, 5‐HT2A, and 5‐HT2C receptors. The compounds with better affinity and selectivity binding profiles toward 5‐HT1A and 5‐HT2C (FG‐1, FG‐4, FG‐5, FG‐6, FG‐7, FG‐8, and FG‐18) are selected for further in vivo assays to determine their functional activity. Finally, to rationalize the obtained results, molecular docking studies are performed. The results of pharmacological studies show that compounds FG‐1, FG‐5, FG‐8, and FG‐6 exert antidepressant‐like effects, and FG‐1, FG‐18, FG‐6, and FG‐7 reveal also significant anxiolytic properties. Among the developed derivatives, the most promising compounds seem to be FG‐1, which exhibit antidepressant, anxiolytic, and anticonvulsant properties, FG‐7 and FG‐18 that show features as anxiolytic combine to a pro‐cognitive property and notable affinity and selectivity for 5‐HT2C receptor, respectively.

2025-01-01·Theranostics

Optical molecular imaging in oral- and oropharyngeal squamous cell carcinoma using a novel uPAR-targeting near-infrared imaging agent FG001 (ICG-glu-glu-AE105): An explorative phase II clinical trial

Article

作者: Kiss, Katalin ; Kjaer, Andreas ; von Buchwald, Christian ; Straede, Karina ; Poulsen, Anne ; Rubek, Nicklas ; Lawaetz, Mads ; Hahn, Christoffer Holst ; Lelkaitis, Giedrius ; Christensen, Anders ; Paaske, Natasja ; Wessel, Irene ; Andersen, Amanda Oester

Background: In oral and oropharyngeal squamous cell carcinoma (OSCC, OPSCC), frequent inadequate surgical margins highlight the importance of precise intraoperative identification and delineation of cancerous tissue for improving patient outcomes. Methods: A prospective, open-label, single-center, single dose, exploratory phase II clinical trial (EudraCT 2022-001361-12) to assess the efficacy of the novel uPAR-targeting near-infrared imaging agent, FG001, for intraoperative detection of OSCC and OPSCC. Macroscopic tumor detection was quantified with sensitivity and intraoperative tumor-to-background ratio (TBR). Microscopic tumor-specificity was assessed by analysis of morphological co-localization between tumor tissue, uPAR-expression, and optical signal. Blood samples were collected up to 44 hours post-injection to further characterize the pharmacokinetic profile of the agent. The trial was conducted with close safety monitoring. Results: Sixteen patients undergoing primary surgical resection were systemically administered 36 mg (n = 4), 16 mg (n = 8), or 4 mg (n = 4) of FG001 the evening prior to surgery. Intraoperatively, using a near-infrared imaging system, real-time optical imaging successfully identified all 16 tumors (sensitivity: 100%, mean TBR: 2.99 range: 2.02 - 3.95), and tumor-specificity was confirmed by histology. Clinical neck metastasis was detected with optical imaging. The maximal plasma concentrations were measured after 1 hour, and the half-life of FG001 was 12 hours. No drug-related or serious adverse events were observed. Conclusions: FG001 holds great potential for optical molecular imaging of OSCC and OPSCC. Further trials are warranted to explore FG001 for intraoperative margin delineation and as a decision-making tool.

项与 FG-001 相关的新闻（医药）

2026-02-25

·BioSpace

FluoGuide A/S Publishes Annual Report For The Fiscal Year 2025

COPENHAGEN, DK / ACCESS Newswire / February 25, 2026 / FluoGuide A/S ("FluoGuide" or the "Company")(STO:FLUO) hereby publishes its annual report for the fiscal year 2025. The annual report, including the auditor's report is attached as a PDF and is also available on FluoGuide's website under ‘Financial reports'. Following a year of significant clinical and regulatory progress in 2025, FluoGuide has reached a key inflection point in 2026. With the IND now cleared by FDA, we have further de-risked our lead program and established a well-defined regulatory pathway toward U.S. approval. Our mission remains unchanged: to maximize outcomes in cancer surgery, and we are now well positioned to advance FG001 toward registration." - Morten Albrechtsen, CEO of FluoGuide. Clinical progress across multiple indications During 2025, FluoGuide advanced FG001 across multiple clinical programs. The Company received CTA approval and enrolled the first patient in its Phase II trial (CT-005) in head and neck cancer, while clinical data in high-grade glioma were published in Neurosurgery. Positive interim results from an investigator-initiated brain tumor trial were also presented at EANS, CNS and EANO. Regulatory advancement During the year, FluoGuide received positive FDA feedback supporting the continued development of FG001. Following the reporting period, the Company submitted an Investigational New Drug (IND) application to initiate the first U.S. registration trial. The IND has afterwards recieved green light from FDA. Strategic collaborations In 2025, FluoGuide entered collaboration agreements with Olympus, a world-leading MedTech company in endoscopic imaging, and ZEISS, a global leader in surgical microscopy, supporting the continued clinical and technological development of FG001. Strengthened financial position During the year, FluoGuide completed a directed share issue of SEK 104 million, securing funding to support the continued clinical development of FG001 and enabling progression toward late-stage clinical activities. Organization and leadership During 2025, FluoGuide strengthened its leadership organization to support clinical development and regulatory execution, including the appointment of a Chief Operating Officer and the election of a new Board member with experience in strategic business development. FINANCIAL HIGHLIGHTS KEY FIGURES 2025 2024 DKK thousand Income statement Other operating income 220 385 Other external expenses -23,980 -17,709 Staff expenses -15,504 -15,259 Depreciation and amortization -558 -456 Income/(Loss) before interest and tax (EBIT) -39,822 -33,040 Net financial items -5,137 -1,419 Income/(Loss) before tax -44,959 -34,459 Tax on income for the year 5,500 5,500 Net result for the year -39,459 -28,959 Balance sheet Non-current assets 1,548 1,877 Current assets 86,744 26,503 Total assets 88,292 28,380 Equity 54,528 23,067 Non-current liabilities 28,038 395 Current liabilities 5,727 4,918 Cash flow statement Cash and cash equivalents 48,785 18,608 Cash flow from: Operating activities -36,957 -29,152 Investing activities -29,904 -987 Financing activities 97,038 27,080 The period's cash flow 30,176 -3,059 Key ratios Equity share (solvency ratio) 62% 81% Earnings per share (DKK) -2.81 -2.23 LOOKING AHEAD - 2026 MILESTONES In H1 enrol first patient in the U.S. for the Phase 2 clinical trial (CT-006) with FG001 in HGG supporting registration In H1 initiate enrolment of the remaining 10 patients with presumable low-grade-glioma (investigator-initiated trial) and in H2 interim result from the clinical trial In H1 interim result of the first 15 patients in the Phase 2 clinical trial (CT-005) in head and neck cancer (CT-005) In H2 enrol the next cohort of 10 patients in the Phase 2 trial (CT-005) for FG001 in head and neck cancer In H2 presentation of a FluoGuide brain tumor plan In H2 to determine the optimization use of FG001 and the laser system in pre-clinical models and to present a plan for further development During the year FluoGuide anticipates entering an additional non-exclusive strategic partnership PRESENTATION In connection with the annual report publication, CEO Morten Albrechtsen and CFO Ole Larsen will participate in a live webcast, hosted by Biostock, on February 25, 2026, at 14.00 CET . Please login to the webcast via the following link: A recorded version of the presentation will be available on FluoGuide's website under Investor Presentations after the webcast has concluded. For further information, please contact: Morten Albrechtsen, CEO FluoGuide A/S Phone: +45 24 25 62 66 E-mail: ma@fluoguide.com Certified Adviser: Svensk Kapitalmarknadsgranskning AB Website: About FluoGuide FluoGuide lights up cancer to maximize surgical outcomes in oncology. FluoGuide's lead product, FG001, is designed to improve surgical precision by lighting up cancer intraoperatively. The improved precision has a dual benefit - it reduces both the frequency of local recurrence post-surgery and lessens surgical sequelae. Ultimately, the improved precision enhances the likelihood of complete cure and lower healthcare costs. FluoGuide has demonstrated that FG001 is both effective and well tolerated in several phase II clinical trials. The lead indications of FG001 are aggressive brain cancer (glioblastoma) and oral head and neck cancer. FluoGuide has entered partnerships with leading MedTech companies with the aim of accelerating development and commercialization. FluoGuide is listed on Nasdaq First North Sweden under the ticker "FLUO". For more information on FG001 or FluoGuide's uPAR technology platform, please visit our home page Attachments FluoGuide Annual Report 2025 SOURCE: FluoGuide A/S View the original press release on ACCESS Newswire

临床2期临床结果财报

2026-02-25

·fluoguide.com

FluoGuide A/S publishes interim report for Q4 2025

“In 2025, FluoGuide achieved several defining milestones that significantly advanced FG001 toward late-stage clinical development and established a clear regulatory pathway toward U.S. approval. The positive clinical data, strengthened organization, successful financing, and strategic collaboration with ZEISS collectively mark our transition from early clinical validation to execution toward registration and future commercialization. As we enter 2026, our focus is clear: advancing FG001 into registration studies and bringing innovative fluorescence-guided surgery closer to patients and surgeons worldwide.” – Morten Albrechtsen, CEO of FluoGuide Clinical progress strengthens FG001 foundation In the fourth quarter, the Company reported positive interim results from an investigator-initiated FG001 trial in meningioma and low-grade glioma. The results were presented at EANS, CNS and EANO. Organization and leadership During Q4 2025, FluoGuide strengthened its leadership organization to support clinical development and regulatory execution, including the appointment of a Chief Operating Officer and the election of a new Board member with experience in strategic business development. Strengthened financial position During the quarter, FluoGuide completed a directed share issue of SEK 104 million, securing funding to support the continued clinical development of FG001 and enabling progression toward late-stage clinical activities. Strategic collaboration with ZEISS In November 2025, FluoGuide entered into a collaboration agreement with ZEISS, a global leader in surgical microscopy. The collaboration supports the integration of FG001 within advanced surgical visualization workflows and represents an important step toward future clinical adoption. Advancing toward U.S. registration Following the end of the reporting period, FluoGuide submitted an Investigational New Drug (IND) application for FG001. The IND has afterwards been cleared by FDA. The clearance represents a key regulatory milestone, establishing a clear pathway toward U.S. registration, with initiation of the first registration trial expected in Q2 2026. Financial results and share information FluoGuide had no revenue Q4 2025 and posted a net loss of DKK 13,090 thousand (Q4 2024: a loss of DKK 8.741 thousand). FluoGuide had no revenue in 2025 and posted a net loss of DKK 39,459 thousand (2024: a net loss of DKK 28,959 thousand). As of December 31, 2025, FluoGuide’s share capital amounted to 1,634,931.30 divided into 16,349,313 shares of nominal value SEK 0.10 each. Highlights during Q4: Completed a directed share issue of SEK 104 million Strengthened leadership to advance clinical program and regulatory approval strategy Collaboration agreement signed with ZEISS, a world-leading company in surgical microscopy Highlights after Q4: The Company submits an IND for FG001, to initiate first U.S. registration trial FDA clears the IND which represents a key regulatory milestone for FluoGuide and marks the transition of FG001 to late-clinical development, advancing the program toward U.S. registration. Initiation of the first registration trial remains on track, with enrollment of the first patient expected in Q2 2026.

财报高管变更引进/卖出临床申请

2026-02-25

·BioSpace

FluoGuide A/S Publishes Interim Report For Q4 2025

COPENHAGEN, DK / ACCESS Newswire / February 25, 2026 / Fluoguide A/S ("FluoGuide" or the "Company")(STO:FLUO) today releases its results for the period 1 January 2025 - 31 December 2025. The Q4 report is available as attached document to this press release and on FluoGuide's website. "In 2025, FluoGuide achieved several defining milestones that significantly advanced FG001 toward late-stage clinical development and established a clear regulatory pathway toward U.S. approval. The positive clinical data, strengthened organization, successful financing, and strategic collaboration with ZEISS collectively mark our transition from early clinical validation to execution toward registration and future commercialization. As we enter 2026, our focus is clear: advancing FG001 into registration studies and bringing innovative fluorescence-guided surgery closer to patients and surgeons worldwide." - Morten Albrechtsen, CEO of FluoGuide. Clinical progress strengthens FG001 foundation In the fourth quarter, the Company reported positive interim results from an investigator-initiated FG001 trial in meningioma and low-grade glioma. The results were presented at EANS, CNS and EANO. Organization and leadership During Q4 2025, FluoGuide strengthened its leadership organization to support clinical development and regulatory execution, including the appointment of a Chief Operating Officer and the election of a new Board member with experience in strategic business development. Strengthened financial position During the quarter, FluoGuide completed a directed share issue of SEK 104 million, securing funding to support the continued clinical development of FG001 and enabling progression toward late-stage clinical activities. Strategic collaboration with ZEISS In November 2025, FluoGuide entered into a collaboration agreement with ZEISS, a global leader in surgical microscopy. The collaboration supports the integration of FG001 within advanced surgical visualization workflows and represents an important step toward future clinical adoption. Advancing toward U.S. registration Following the end of the reporting period, FluoGuide submitted an Investigational New Drug (IND) application for FG001. The IND has afterwards been cleared by FDA. The clearance represents a key regulatory milestone, establishing a clear pathway toward U.S. registration, with initiation of the first registration trial expected in Q2 2026. Financial results and share information FluoGuide had no revenue Q4 2025 and posted a net loss of DKK 13,090 thousand (Q4 2024: a loss of DKK 8.741 thousand). FluoGuide had no revenue in 2025 and posted a net loss of DKK 39,459 thousand (2024: a net loss of DKK 28,959 thousand). As of December 31, 2025, FluoGuide's share capital amounted to 1,634,931.30 divided into 16,349,313 shares of nominal value SEK 0.10 each. KEY FIGURES Q4 2025 Q4 2024 2025 2024 DKK thousand 01-Oct-25 01-Oct-24 01-Jan-25 01-Jan-24 31-Dec-25 31-Dec-24 31-Dec-25 31-Dec-24 Income statement Other operating income 54 -642 220 385 Other external expenses -6,336 -5,467 -23,980 -17,709 Staff expenses -4,837 -3,805 -15,504 -15,259 Depreciation and amortization -135 -134 -558 -456 Income/(Loss) before interest and tax (EBIT) -11,253 -10,048 -39,822 -33,040 Net financial items -2,166 -143 -5,137 -1,419 Income/(Loss) before tax -13,420 -10,191 -44,959 -34,459 Tax on income 330 1,450 5,500 5,500 Net result -13,090 -8,741 -39,459 -28,959 Balance sheet Non-current assets 1,548 1,877 1,548 1,877 Current assets 86,744 26,503 86,744 26,503 Total assets 88,292 28,380 88,292 28,380 Equity 54,528 23,067 54,528 23,067 Non-current liabilities 28,038 395 623 0 Current liabilities 5,727 4,918 5,727 4,918 Cash flow statement Cash and cash equivalents 48,785 18,608 48,785 18,608 Cash flow from: Operating activities -5,032 -1,476 -36,957 -29,152 Investing activities -30,015 -20 -29,904 -987 Financing activities 70,137 -53 97,038 27,080 The period's cash flow 35,089 -1,548 30,176 -3,059 Key ratios Equity share (solvency ratio) 62% 81% 62% 81% Earnings per share (DKK) -0.85 -0.64 -2.81 -2.23 Highlights during Q4: Completed a directed share issue of SEK 104 million Strengthened leadership to advance clinical program and regulatory approval strategy Collaboration agreement signed with ZEISS, a world-leading company in surgical microscopy Highlights after Q4: The Company submits an IND for FG001, to initiate first U.S. registration trial FDA clears the IND which represents a key regulatory milestone for FluoGuide and marks the transition of FG001 to late-clinical development, advancing the program toward U.S. registration. Initiation of the first registration trial remains on track, with enrollment of the first patient expected in Q2 2026. For further information, please contact: Morten Albrechtsen, CEO FluoGuide A/S Phone: +45 24 25 62 66 E-mail: ma@fluoguide.com Certified Adviser: Svensk Kapitalmarknadsgranskning AB Website: About FluoGuide FluoGuide lights up cancer to maximize surgical outcomes in oncology. FluoGuide's lead product, FG001, is designed to improve surgical precision by lighting up cancer intraoperatively. The improved precision has a dual benefit - it reduces both the frequency of local recurrence post-surgery and lessens surgical sequelae. Ultimately, the improved precision enhances the likelihood of complete cure and lower healthcare costs. FluoGuide has demonstrated that FG001 is both effective and well tolerated in several phase II clinical trials. The lead indications of FG001 are aggressive brain cancer (glioblastoma) and oral head and neck cancer. FluoGuide has entered partnerships with leading MedTech companies with the aim of accelerating development and commercialization. FluoGuide is listed on Nasdaq First North Sweden under the ticker "FLUO". For more information on FG001 or FluoGuide's uPAR technology platform, please visit our home page Attachments FluoGuide Q4 2025 SOURCE: FluoGuide A/S View the original press release on ACCESS Newswire

临床2期临床结果财报高管变更引进/卖出

100 项与 FG-001 相关的药物交易

登录后查看更多信息

研发状态

10 条进展最快的记录,

后查看更多信息

适应症	最高研发状态	国家/地区	公司	日期
头颈部肿瘤	临床2期	丹麦	FluoGuide A/S	2022-01-30
高级别胶质瘤	临床2期	丹麦	FluoGuide A/S	2022-01-30
非小细胞肺癌	临床2期	丹麦	FluoGuide A/S	2022-01-30

登录后查看更多信息

临床结果

适应症

分期

评价

查看全部结果

研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


Pubmed 人工标引	临床1期	脑恶性胶质瘤 \| 脑癌	35	FG001	艱衊夢淵衊齋獵製衊獵(繭鹽製鏇齋膚鑰鑰膚遞) = 膚憲範構窪餘製窪構淵淵醖醖餘糧膚製餘製積 (鬱構蓋積衊壓鏇蓋鬱廠 ) 更多	积极	2025-06-03
FG001-CT-001 (Corporate Publications) 人工标引	临床2期	高级别胶质瘤	24	FG001	築襯餘齋簾顧顧網繭醖(憲願網鏇艱遞觸醖簾選) = 膚獵膚壓膚簾願構餘獵壓窪選廠鏇選構鏇築鬱 (壓鑰壓齋夢餘構選鑰繭 ) 达到更多	积极	2023-11-13
FG001-CT-001 (Corporate Publications) 人工标引	临床2期	高级别胶质瘤	24	5-ALA	築襯餘齋簾顧顧網繭醖(憲願網鏇艱遞觸醖簾選) = 遞廠壓鬱簾築願蓋簾餘壓窪選廠鏇選構鏇築鬱 (壓鑰壓齋夢餘構選鑰繭 ) 达到	积极	2023-11-13
PipelineReview 人工标引	临床2期	头颈部肿瘤	16	FG001	網築簾獵遞顧憲選鑰醖(鏇範遞淵糧範網襯糧壓) = 願襯製構願構選夢膚獵膚襯選選膚願構夢憲積 (鑰製築築餘遞鹽夢鏇襯 )	积极	2023-11-06