Non-inferiority, Phase IV, Open-label, Randomized Controlled Trial of Vesical Imaging- Reporting and Data System (VI-RADS) Followed by Primary Photodynamic Trans-urethral Resection of Bladder Tumours (PDD-TURBT) Versus Conventional White-light TURBT Plus Repeated-TURBT (Re-TURBT) in Non-Muscle Invasive Bladder Cancers (NMIBCs) Candidate for Second Look and Resection

Background: In European Association of Urology (EAU) Guidelines, the vast majority of non-muscle-invasive bladder cancers (NMIBCs) undergo a primary transurethral resection of the bladder tumor (TURBT) followed by a repeat TURBT (Re-TURBT). The Re-TURBT is recommended due to the possibility of residual bladder cancer but is unnecessary in many cases by constituting overtreatment. Currently, no diagnostic strategy or predictive tools have been implemented to further stratify who does or does not benefit from Re-TURBT. Recently, an MRI-based Vesical Imaging Reporting and Data System (VI-RADS) score has been developed to stage as to the preoperative probability of muscle invasion, which could potentially exclude those who do not require a Re-TURBT when a primary high-quality resection is delivered. As such, performing TURBT with standard white light (WL) cystoscopy is known to miss many bladder tumours, which may be poorly visible, and a technique known as with photodynamic diagnosis (PDD) results in lower residual tumor and lower early intravesical recurrence rates. PDD is performed using violet light to improve the detection of these lesions not easily visible with WL cystoscopy.
Methods/Aims: The investigators propose an Italian, single-center, phase IV, open-label, non-inferiority, randomized controlled trial, in which participants (n=112) who had already received a mpMRI/VI-RADS score, are randomized to receive PDD-TURBT, no Re-TURBT versus standard of care represented by conventional WL-TURBT followed by WL-Re-TURBT. The primary outcome is proportions of early recurrence in the urinary bladder. Secondary outcomes will include proportions of late BCa recurrence, late disease-free interval, time to progression to MIBC, patient's quality of life assessment, and cost-analysis.
Perspective: The CUT-less trial aims to respond to this unmet need through a non-inferiority randomized clinical study potentially shaping the perspective for a paradigm shift towards a more personalized, socially, and economically sustainable updated NMIBC therapeutic pathway.
Implications: The current clinical trial proposal is aiming to achieve a paradigm shift in the oncological and socio-economical management of urothelial malignancies of the urinary bladder. Our first concern is indeed to guarantee a safe and ground-breaking strategy to manage the pathway of such patients in order to guarantee the non-inferior oncologic safety (and possibly superiority) when compared to the current standard of care.
Additionally, if our hypotheses are confirmed, the investigators will be able to significantly relieve these patients from the oncologic burden of an already invasive and arduous bladder cancer care path. Finally, safely avoiding an unnecessary, expensive surgical procedure will bring significant social and economic benefits to the EU healthcare system and possibly worldwide.

Start Date01 Jan 2025

Sponsor / Collaborator-

NCT06525571

/ RecruitingPhase 3IIT

Outcomes of High-risk Non-muscle Invasive Bladder Cancer Treated With Blue Light Resection

Comparing white-light cystoscopy (WLC) and blue-light cystoscopy (BLC) in TURBT for high risk (HR) non-muscle invasive bladder cancer (NMIBC) patients is crucial to determine the most effective method for reducing residual disease burden and improving recurrence-free survival. Enhanced visualization with BLC may lead to more accurate resections, potentially decreasing recurrence rates and improving long-term outcomes for bladder cancer patients. Patients will be randomized to either WLC TURBT or BLC TURBT, and outcomes will be measured using standard-of-care testing with cystoscopy and cytology, along with minimal residual disease (MRD) burden evaluation using urine next-generation sequencing.

Start Date20 Dec 2024

Sponsor / Collaborator

The Johns Hopkins University

[+1]

NCT05600322

/ CompletedPhase 3

A Prospective, Comparative Within Patient Controlled, Multi-center Study of Hexvix Blue Light Cystoscopy and White Light Cystoscopy in the Detection of Bladder Cancer

A study to compare Hexvix Blue light cstoscopy with standard White light cystoscopy in the detection of bladder cancer.

Start Date03 Nov 2022

Sponsor / Collaborator

Photocure ASA

[+2]

100 Clinical Results associated with Hexaminolevulinate Hydrochloride

100 Translational Medicine associated with Hexaminolevulinate Hydrochloride

100 Patents (Medical) associated with Hexaminolevulinate Hydrochloride

199

Literatures (Medical) associated with Hexaminolevulinate Hydrochloride

01 Feb 2025·Photodiagnosis and Photodynamic Therapy

Long-term outcome of photodynamic therapy with hexyl aminolevulinate, 5-aminolevulinic acid nanoemulsion and methyl aminolevulinate for low-risk Basal Cell Carcinomas

Article

Author: Grönroos, M ; Snellman, E ; Salmivuori, M ; Räsänen, J ; Tani, T ; Neittaanmäki, N

BACKGROUNDNon-surgical treatments are cost-effective options for low-risk basal cell carcinomas (BCCs) i.e. superficial or small nodular BCCs located outside the high-risk locations. Hexyl aminolevulinate (HAL) and 5-aminolevulinic acid nanoemulsion (BF-200 ALA) with enhanced penetration depth enables the use of lower concentrations compared to methylaminolevulinate (MAL) in photodynamic therapy (PDT). We have previously reported comparable short-term efficacies for MAL 16 %, BF-200 ALA 7.8 % and HAL 2 % in PDT of low-risk BCC, and here we report the long-term results.OBJECTIVESThe goal of this trial was to compare long-term outcomes of HAL and BF-200 ALA, compared to MAL in PDT of low-risk BCCs.METHODSNinety-eight histologically verified low-risk BCCs on the trunk or extremities were included and randomized into three arms to receive PDT in two sessions with MAL, BF-200 ALA or HAL. A blinded dermatologist assessed the response, cosmetic outcome, and obtained biopsies for histological verification at three months, one year and five years. Histologically verified non-responsive lesions were excised. Patients' satisfaction with the treatment was also queried.RESULTSAccording to intention-to-treat (ITT) analyses, the cumulative response rate at one year was 90.6 % for MAL, 81.3 % for BF-200 ALA, and 75.8 % for HAL, and correspondingly at five years 71.9 %, 54.6 % and 60.6 %. There were no statistically significant differences between interventions and comparator. The overall cumulative response rate for PDT was 82.5 % at one year and 62.2 % at five, and 48.6 % of the treatment failures were recorded at five years. The recurrent lesions were excised as second line treatment. No aggressive subtypes were reported, with only superficial or nodular growth in the final histopathological report. There were no significant differences in cosmetic outcome or patient satisfaction.CONCLUSIONSThis trial shows that HAL has potential for dermatological PDT. However, the long-term efficacy of PDT in the treatment of low-risk BCCs remains rather low.

01 Nov 2024·Photochemistry and Photobiology

Preclinical evaluation of singlet oxygen‐cleavable prodrugs in combination with protoporphyrin IX‐photodynamic therapy in an orthotopic rat model of non‐muscle‐invasive bladder cancer

Article

Author: You, Youngjae ; Foster, Barbara A. ; Rahman, Kazi Md Mahabubur

AbstractPhotodynamic therapy (PDT) initially employed red light, which caused some patients to experience permanent bladder contractions. PDT using the FDA‐approved drug hexaminolevulinate (HAL), which produces protoporphyrin IX (PpIX) in the tumor, showed some promise but has low efficacy in treating non‐muscle‐invasive bladder cancer (NMIBC). We developed singlet oxygen‐activatable prodrugs of two anticancer drugs, paclitaxel and mitomycin C, to enhance the antitumor effect of PpIX‐PDT without producing systemic side effects, by promoting only local release of the active chemotherapeutic agent. Orthotopic NMIBC model was used to compare the efficacy of prodrugs only, PpIX‐PDT, and prodrugs + PpIX‐PDT. 532 nm laser with a total power of 50 mW for 20 min (60 J, single treatment) was used with HAL and prodrugs. Histology and microscopic methods with image analysis were used to evaluate the tumor staging, antitumor efficacy, and local toxicity. Prodrug + PpIX‐PDT produced superior antitumor efficacy than PpIX‐PDT alone with statistical significance. Both PpIX‐PDT alone and combination therapy resulted in mild damage to the bladder epithelium in the normal bladder area with no apparent damage to the muscle layer. Overall, SO‐cleavable prodrugs improved the antitumor efficacy of PpIX‐PDT without causing severe and permanent damage to the bladder muscle layer.

01 Nov 2024·Photochemistry and Photobiology

Mitochondrial targeting improves the selectivity of singlet‐oxygen cleavable prodrugs in NMIBC treatment

Article

Author: Woo, Sukyung ; Foster, Barbara A. ; Kumbham, Soniya ; You, Youngjae ; Bist, Ganesh ; Rahman, Kazi Md Mahabubur

AbstractMitochondria play an essential role in cancer treatment by providing apoptotic signals. Hexyl aminolevulinate, an FDA‐approved diagnosis for non‐muscle invasive bladder cancer, induces the production of protoporphyrin IX (PpIX) preferentially by mitochondria in cancer cells. Photosensitizer PpIX upon illumination can release active chemotherapy drugs from singlet oxygen‐activatable prodrugs. Prodrugs placed close enough to PpIX formed in mitochondria can improve the antitumor efficiency of PpIX‐PDT. The preferred uptake of prodrugs by cancer cells and tumors can further enhance the selective damage of cancer cells over non‐cancer cells and surrounding normal tissues. Mitochondriotropic prodrugs of anticancer drugs, such as paclitaxel and SN‐38, were synthesized using rhodamine, a mitochondrial‐targeting moiety. In vitro, the mitochondrial targeting helped achieve preferential cellular uptake in cancer cells. In RT112 cells (human bladder cancer cells), intracellular prodrug concentrations were 2–3 times higher than the intracellular prodrug concentrations in BdEC cells (human bladder epithelial cells), after 2 h incubation. In an orthotopic rat bladder tumor model, mitochondria‐targeted prodrugs achieved as much as 34 times higher prodrug diffusion in the tumor area compared to the nontumor bladder area. Overall, mitochondria targeting made prodrugs more effective in targeting cancer cells and tumors over non‐tumor areas, thereby reducing nonspecific toxicity.

News (Medical) associated with Hexaminolevulinate Hydrochloride

13 Nov 2024

·www.prnewswire.com

Photocure ASA: Results for the third quarter of 2024

OSLO, Norway, Nov. 13, 2024 /PRNewswire/ -- Photocure ASA (OSE: PHO) today reported Hexvix®/Cysview® revenues of NOK 120.1 million in the third quarter of 2024 (Q3 2023: NOK 107.3 million), and EBITDA of NOK 5.0 million (NOK 3.3 million) for the Company. Photocure reiterates its 2024 financial guidance and continues to expect consolidated product revenue growth of 6% to 9% in constant currency and positive EBITDA excluding business development expenses. "We delivered solid performance in the third quarter, generating 12% Hexvix/Cysview revenue growth and NOK 5.0 million in EBITDA. Year-to-date, we have reported 9% growth in product revenues. Our business segments in North American and Europe both generated positive contributions during the quarter, and we made progress on key initiatives that we are pursuing to accelerate our growth going forward," says Dan Schneider, President & Chief Executive Officer of Photocure. Photocure reported total group revenues of NOK 120.2 million in the third quarter of 2024 (NOK 107.5 million), and EBITDA* of NOK 5.0 million (NOK 3.3 million), driven by revenue growth in North America and Europe. Hexvix/Cysview revenues ended at NOK 120.1 million in the quarter (Q3 2023: NOK 107.3 million). The EBIT was NOK -2.2 million (NOK -3.9 million) and the cash balance at the end of the period was NOK 291.1 million. At the end of the third quarter of 2024, the installed base of rigid BLC systems in the U.S. was 387, up 13% since Q3 2023. This includes 18 mobile towers owned by ForTec Medical. Photocure estimates that 25 flexible BLC towers remain in the U.S. market. Photocure also entered into a strategic agreement with Richard Wolf GmbH to develop and commercialize a next-generation flexible blue light cystoscope based on Richard Wolf's system blue technology with the goal to reintroduce and grow the use of BLC with Cysview/Hexvix in the surveillance setting. "We are also positioning for the future with our Richard Wolf partnership to develop and commercialize a state-of-the-art flexible high-definition blue light system. This partnership is focused on ensuring that physicians and patients have reliable access to high quality BLC equipment in the surveillance setting. The development project is well underway, with the goal to bring a new flexible BLC system to patients globally as soon as possible. Additionally, the Karl Storz' Citizen's Petition to have BLC equipment reclassified in the U.S. from Class 3 to Class 2 is another significant opportunity that we continue to monitor and pro-actively support," Schneider adds. Photocure believes that the benefits of Blue Light Cystoscopy with Hexvix/Cysview offering superior detection and management of bladder cancer will continue to be adopted and become the standard of care. Photocure reiterates its 2024 guidance and continues to expect consolidated product revenue growth of 6% to 9% in constant currency, positive EBITDA excluding business development expenses, and new and upgraded Saphira™ installations in the U.S. in the range of 55 to 70 towers. "With our business continuing to show steady growth, industry trends in our favor, and a number of initiatives underway that can enable Hexvix/Cysview to grow faster, I believe that Photocure is well-positioned to deliver value to patients and our shareholders in the coming quarters," Schneider concludes. Please find the full financial report and presentation enclosed. EBITDA* and other alternative performance measures (APMs) are defined and reconciled to the IFRS financial statements as a part of the APM section of the third quarter 2024 financial report on page 23. The quarterly report and presentation will be published at 08:00 CET and will be publicly available at . Dan Schneider, CEO and Erik Dahl, CFO, will host a live webcast at 14:00 CET. The presentation will be held in English and questions can be submitted throughout the event. The streaming event is available through The presentation is scheduled to conclude at 14:45 CET. For further information, please contact: Dan Schneider President and CEO Photocure ASA Email: [email protected] Erik Dahl Chief Financial Officer Email: [email protected] David Moskowitz Vice President of Investor Relations Tel: +1 202 280 0888 Email: [email protected] Media and IR enquiries: Geir Bjørlo Corporate Communications (Norway) Tel: +47 91540000 Email: [email protected] About Photocure ASA Photocure: The Bladder Cancer Company delivers transformative solutions to improve the lives of bladder cancer patients. Our unique technology, making cancer cells glow bright pink, has led to better health outcomes for patients worldwide. Photocure is headquartered in Oslo, Norway and listed on the Oslo Stock Exchange (OSE: PHO). For more information, please visit us at , , All trademarks mentioned in this release are protected by law and are registered trademarks of Photocure ASA. This information is considered to be inside information pursuant to the EU Market Abuse Regulation and is subject to the disclosure requirements pursuant to section 5-12 of the Norwegian Securities Trading Act. This stock exchange announcement was published by Tolv Hillestad, Group Controller, Photocure ASA, on 13 November 2024 at 08:00 CET. This information was brought to you by Cision The following files are available for download: SOURCE Photocure WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Financial Statement

30 Sep 2024

·www.prnewswire.com

Photocure Partner Asieris Unveils Cevira (APL-1702) Phase III Subgroup Analysis by Age Groups at the 2024 CSCO Annual Meeting

OSLO, Norway, Sept. 30, 2024 /PRNewswire/ -- Photocure ASA (OSE: PHO) , the Bladder Cancer Company, announces that its partner Asieris Pharmaceuticals (SSE: 688176) communicated that international multicenter Phase III clinical study data for its non-surgical treatment candidate Cevira® (APL-1702) for cervical High-Grade Squamous Intraepithelial Lesion (HSIL) has been published by the 27th Chinese Society of Clinical Oncology (CSCO) Annual Meeting as a poster, focusing on the analysis of different age subgroups regarding the six-month pathological regression rate and HPV clearance rate. This Phase III clinical trial is a prospective, randomized, double blind, placebo controlled, multi-center clinical study, which has reached its primary efficacy endpoint and exhibited good safety. Furthermore, the study results included the pathological regression rate (defined as the proportion of subjects with a pathological regression to CIN1 or normal tissue) at the 6th month across different age subgroups. Both the "≥20 and <30 years" subgroup and the "≥30 and <40 years" subgroup showed an increase of 15% to 20% in the pathological regression rate in the APL-1702 group compared to the placebo control group. No cervical cancer events were reported, suggesting a significant therapeutic potential of APL-1702 in the HSIL population aged 20 to 40 years. Regarding HPV clearance rate, in the "≥20 and <30 years" age group, the APL-1702 group showed enhancements in the overall HPV clearance rate, HPV16-positive clearance rate, and HPV16/18-positive clearance rate compared to the placebo control group. The patients' number in the "<20 years" and "≥40 years" age groups were limited, thus the results in these age groups require a validation study with a larger sample size. Overall, APL-1702 not only facilitates the regression from HSIL to LSIL but also demonstrates the ability to induce clearance of high-risk HPV infections. Read Asieris' full media release here: Note to editors: All trademarks mentioned in this release are protected by law and are registered trademarks of Photocure ASA. This press release may contain product details and information which are not valid, or a product is not accessible, in your country. Please be aware that Photocure does not take any responsibility for accessing such information which may not comply with any legal process, regulation, registration or usage in the country of your origin. About Cevira® Cevira® (APL-1702) is a photodynamic drug-device combination product in development. Based on the principles of photodynamic therapy, the Cevira product aims to use a photosensitizer in combination with light activation to produce a therapeutic effect as a non-surgical treatment of high-grade squamous intraepithelial lesions (HSIL) in patients aged 18 years and above, excluding carcinoma in situ. Photocure developed Cevira through Phase I and Phase II trials, and the global rights for development and commercialization were out-licensed to Asieris Meditech Co., Ltd in 2019. In November 2020 Asieris initiated the phase III clinical trial for APL-1702 (Cevira) which achieved its primary endpoint in September 2023, Clinical trial number: NCT04484415. The new drug application for APL-1702 was accepted by the National Medical Products Administration (NMPA) in May 2024. About Photocure ASA Photocure: The Bladder Cancer Company delivers transformative solutions to improve the lives of bladder cancer patients. Our unique technology, making cancer cells glow bright pink, has led to better health outcomes for patients worldwide. Photocure is headquartered in Oslo, Norway and listed on the Oslo Stock Exchange (OSE: PHO). For more information, please visit us at About Asieris Asieris Pharmaceuticals(688176.SH), founded in March 2010, is a global biopharma company specializing in discovering, developing and commercializing innovative drugs for the treatment of genitourinary tumors and other related diseases. For further information, please contact: Dan Schneider President and CEO Photocure ASA Email: [email protected] Erik Dahl CFO Photocure ASA Tel: +4745055000 Email: [email protected] David Moskowitz Vice President, Investor Relations Photocure ASA Tel: +1 202 280 0888 Email: [email protected] Media and IR enquiries: Geir Bjørlo Corporate Communications (Norway) Tel: +47 91540000 Email: [email protected] This information was brought to you by Cision The following files are available for download: SOURCE Photocure WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Phase 3Phase 2Clinical ResultASCOPhase 1

27 Sep 2024

·www.prnewswire.com

Photocure establishes Named Patient Program to provide access to Hexvix in South Africa

OSLO, Norway, Sept. 27, 2024 /PRNewswire/ -- Photocure ASA (OSE: PHO) , the Bladder Cancer Company, announces that it entered into an agreement with Equity Pharmaceuticals PTY Limited, part of the Clinigen group, in September, to initiate a Named Patient Program (NPP) enabling bladder cancer patients in South Africa to receive blue light cystoscopy (BLC®) with Hexvix®. Named Patient Programs (NPPs) provide access to medicines in response to requests by physicians on behalf of specific, or 'named,' patients when those medicines are not licensed or available in the patients' home country. Photocure's NPP with Equity Pharmaceuticals is designed to ensure that physicians can request Hexvix on behalf of individual patients residing in South Africa, with suspected or recurring bladder tumors. Hexvix blue light cystoscopy is indicated as adjunct to standard white light cystoscopy to contribute to the diagnosis and management of bladder cancer in patients with known or high suspicion of bladder cancer. Equity Pharmaceuticals will administer the NPP, and product sales are anticipated to begin in Q4 2024. "Without this NPP, BLC with Hexvix would not otherwise be available to bladder cancer patients in South Africa. Photocure is committed to ensuring global access to Hexvix as part of its sustainability goals," said Dan Schneider, President and CEO of Photocure. "We see this program as a stepstone to trialing various ways in which Hexvix can be made available to patients and urologists in countries where BLC equipment is already accessible." Note to editors: All trademarks mentioned in this release are protected by law and are registered trademarks of Photocure ASA. This press release may contain product details and information which are not valid, or a product is not accessible, in your country. Please be aware that Photocure does not take any responsibility for accessing such information which may not comply with any legal process, regulation, registration or usage in the country of your origin. About Bladder Cancer Bladder cancer ranks as the 8th most common cancer worldwide – the 5th most common in men – with 1,949,000 prevalent cases (5-year prevalence rate)1a, 6,14,000 new cases and more than 2,20,000 deaths in 2022.1b Approx. 75% of all bladder cancer cases occur in men.1 It has a high recurrence rate with up to 61% in year one and up to 78% over five years.2 Bladder cancer has the highest lifetime treatment costs per patient of all cancers.3 Bladder cancer is a costly, potentially progressive disease for which patients have to undergo multiple cystoscopies due to the high risk of recurrence. There is an urgent need to improve both the diagnosis and the management of bladder cancer for the benefit of patients and healthcare systems alike. Bladder cancer is classified into two types, non-muscle invasive bladder cancer (NMIBC) and muscle-invasive bladder cancer (MIBC), depending on the depth of invasion in the bladder wall. NMIBC remains in the inner layer of cells lining the bladder. These cancers are the most common (75%) of all BC cases and include the subtypes Ta, carcinoma in situ (CIS) and T1 lesions. In MIBC the cancer has grown into deeper layers of the bladder wall. These cancers, including subtypes T2, T3 and T4, are more likely to spread and are harder to treat.4 1 Globocan. a) 5-year prevalence / b) incidence/mortality by population. Available at: , accessed [February 2024]. 2 Babjuk M, et al. Eur Urol. 2019; 76(5): 639-657 3 Sievert KD et al. World J Urol 2009;27:295–300 4 Bladder Cancer. American Cancer Society. About Hexvix®/Cysview® (hexaminolevulinate HCl) Hexvix/Cysview is a drug that preferentially accumulates in cancer cells in the bladder, making them glow bright pink during Blue Light Cystoscopy (BLC®). BLC with Hexvix/Cysview, compared to standard white light cystoscopy alone, improves the detection of tumors and leads to more complete resection, fewer residual tumors, and better management decisions. Cysview is the tradename in the U.S. and Canada, Hexvix is the tradename in all other markets. Photocure is commercializing Cysview/Hexvix directly in the U.S. and Europe and has strategic partnerships for the commercialization of Hexvix/Cysview in China, Chile, Australia, New Zealand and Israel. Please refer to for further information on our commercial partners. About Photocure ASA Photocure: The Bladder Cancer Company delivers transformative solutions to improve the lives of bladder cancer patients. Our unique technology, making cancer cells glow bright pink, has led to better health outcomes for patients worldwide. Photocure is headquartered in Oslo, Norway and listed on the Oslo Stock Exchange (OSE: PHO). For more information, please visit us at , , . About Clinigen Clinigen is a global, specialist pharmaceutical services company focused on providing ethical access to medicines. Its mission is to accelerate access to medicines for patients in every corner of the globe. The Group supports pharmaceutical and biotech companies across the medical product lifecycle, from clinical through to commercial and operates from sites in North America, Europe, Africa and the Asia Pacific. Clinigen has more than 1,000 employees across five continents in 15 countries and provides access in more than 130 countries every year. For more information on Clinigen, please visit . For further information, please contact: Dan Schneider President and CEO Photocure ASA Email: [email protected] Erik Dahl CFO Photocure ASA Tel: +4745055000 Email: [email protected] David Moskowitz Vice President, Investor Relations Photocure ASA Tel: +1 202 280 0888 Email: [email protected] Media and IR enquiries: Geir Bjørlo Corporate Communications (Norway) Tel: +47 91540000 Email: [email protected] This information was brought to you by Cision The following files are available for download: WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

100 Deals associated with Hexaminolevulinate Hydrochloride

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KEGG	Wiki	ATC	Drug Bank
D04436	-	V04CX	DB06261

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Carcinoma in Situ	US	Photocure ASA	15 Feb 2018
Bladder Cancer	SE	Photocure ASA	01 Mar 2005
Diagnostic agents	SE	Photocure ASA	01 Mar 2005

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Squamous Intraepithelial Lesions of the Cervix	NDA/BLA	CN	Trettiosjucorp AB	11 May 2024
Squamous Intraepithelial Lesions of the Cervix	NDA/BLA	CN	Asieris Meditech (Hong Kong) Co Ltd	11 May 2024
Squamous Intraepithelial Lesions of the Cervix	NDA/BLA	CN	Asieris Pharmaceuticals Co., Ltd.	11 May 2024
Bladder Cancer	NDA/BLA	CN	Patheon Italia SpA	29 Nov 2023
Bladder Cancer	NDA/BLA	CN	Photocure ASA	29 Nov 2023
Bladder Cancer	NDA/BLA	CN	Fresenius Kabi Austria GmbH	29 Nov 2023
Non-Muscle Invasive Bladder Neoplasms	Phase 1	CA	Photocure ASA	01 Jan 2005
Non-Muscle Invasive Bladder Neoplasms	Phase 1	US	Photocure ASA	01 Jan 2005
Non-Muscle Invasive Bladder Neoplasms	Phase 1	AT	Photocure ASA	01 Jan 2005
Non-Muscle Invasive Bladder Neoplasms	Phase 1	DE	Photocure ASA	01 Jan 2005

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04484415 (NEWS) Manual	Phase 3	Squamous Intraepithelial Lesions of the Cervix	-	APL-1702	(owlbyvilno) = svvatybswl saxdexfrwz (qhfxvqoach ) View more	Positive	12 Nov 2024
				Placebo	(owlbyvilno) = seqesmvuff saxdexfrwz (qhfxvqoach ) View more
NCT05600322 (CTgov)	Phase 3	Bladder Cancer	158	Richard Wolf Photodynamic Diagnostic Equipment (PDD) system+Hexaminolevulinate Hydrochloride	sybuqaaudl(ybibtylvzo) = ypqcxusqpj lnxcngzurg (jrbqcrcvjw, zjkpxleabe - eakkarffdw) View more	-	03 Oct 2024
Company_Website Manual	Phase 3	Squamous Intraepithelial Lesions of the Cervix	-	APL-1702 (Age ≥20 and <30)	meohbmsnlp(rucslfwqdt) = bmpkxaqpdl gvzpxxedpg (fytpqmahzo ) View more	Positive	29 Sep 2024
				PBO (Age ≥20 and <30)	meohbmsnlp(rucslfwqdt) = fjfdrwtvkt gvzpxxedpg (fytpqmahzo ) View more
Company_Website Manual	Phase 3	Squamous Intraepithelial Lesions of the Cervix	-	APL-1702	(aurksjjwxf) = svpnntkagx qjdorrjufg (zojssvxues ) View more	Positive	17 Sep 2024
				Placebo	(aurksjjwxf) = dcdwccapfm qjdorrjufg (zojssvxues ) View more
NCT04484415 (APRICITY, Biospace) Manual	Phase 3	Squamous Intraepithelial Lesions	402	Cevira (APL-1702)	(rwamsyqflt) = tahuksjduc wjugldqhsa (bvwcouxeui ) View more	Positive	18 Mar 2024
				Placebo	(rwamsyqflt) = vonmwaiuwo wjugldqhsa (bvwcouxeui ) View more
PRNewswire Manual	Phase 3	Squamous Intraepithelial Lesions	402	Cevira (APL-1702)	(ndtgufmmdh) = sukktmncng xhvonwxgmf (yawheofgxg ) View more	Positive	18 Mar 2024
				Placebo	(ndtgufmmdh) = igeskcqwny xhvonwxgmf (yawheofgxg ) View more
NCT03058705 (CTgov)	Not Applicable	Bladder Cancer	10	Near Infrared Fluorescence (NIRF)+Hexaminolevulinate HCL	mdmfjzsxag(kwtoqzlrhz) = dtztdkenmk voivpzesab (aelykxkobj, kxwtpcvjhi - lptfoqwjti) View more	-	19 Aug 2019
MP43-06 (AUA2019)	Not Applicable	Non-Muscle Invasive Bladder Neoplasms	208	Blue light cystoscopy with hexaminolevulinate	gxxdqrfnxs(eyjgjrxkca) = tonbapyjba mpkpsvbcaw (jfyykdivif ) View more	-	01 Apr 2019
NCT02560584 (CTgov)	Phase 3	Bladder Cancer	304	KARL STORZ D-Light C PDD Flexible Videoscope System+Hexaminolevulinate hydrochloride	xgeyhamrek(qldlmityyc) = xquxwedpry uqopdfxbja (mfouzbzeyy, eknccamcrh - zbnffvacdr) View more	-	02 Jul 2018
NCT02560584 \| NCT02660645 (Pubmed \| J Urol)	Phase 3	Bladder Cancer	304	Hexaminolevulinate (Blue light flexible cystoscopy)	kzvqjixnvk(qcfmpxqsxv) = kmqktriarm kpgftdeisr (kukmhmqsec, 17.2 - 55.7) View more	-	01 May 2018
				Hexaminolevulinate (White light flexible cystoscopy)	sqazdewpty(eczrtfcwtr) = odntrrjtwm hejfdgwbgm (eyvdgmomar )

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Hexaminolevulinate Hydrochloride

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