hexaminolevulinate

also known as HAL · Hexvix · Cysview · hexaminolevulinate hydrochloride · Cysview kit · HAL hydrochloride · hexaminolaevulinate · Hexaminolevulinate HCL · +4 more

Small molecule

Regulatory milestones approvals, filings & regulatory actions · 6 recorded

Milestone	Jurisdiction	Brand	Indication	Date	Sentence it was read from
Filed urinary bladder anterior wall cancer 4 milestones
Filed	China (NMPA)	Hexvix	urinary bladder anterior wall cancer	2023-11-29	“National Medical Products Administration (NMPA) accepted the new drug application (NDA) for Hexvix ® (APL-1706) in China.” photocure.com ↗
Filed	Other	Hexvix	urinary bladder anterior wall cancer	2021-05-18	“Instituto de Salud Pública de Chile that the Marketing Authorization Application (“MAA”) for Hexvix ® has been accepted for regulatory review.” photocure.com ↗
Filed	US (FDA)	Cysview	urinary bladder anterior wall cancer	2017-08-16	“filed a supplemental new drug application (sNDA) with the U.S. Food and Drug Administration (FDA) for BLC (TM) with Cysview ®” photocure.com ↗ “FDA accepted for review and granted priority review status to the sNDA for Cysview” photocure.com ↗
Filed	Other	Hexvix	urinary bladder anterior wall cancer	2015-09-04	“Juno Pharmaceuticals, has filed a marketing authorization application (MAA) for the registration of Hexvix in Australia.” photocure.com ↗
Approved Indication not stated 2 milestones
Label expansion	US (FDA)	CYSVIEW KIT	—	2018-02-15	fda.gov ↗
Approved	US (FDA)	CYSVIEW KIT	—	2010-05-28	fda.gov ↗

Trials 17

today

US approved 2010

NCT07669363 · Ph 2 NCT05962541 · Ph 4 NCT06525571 · Ph 3 NCT05600322 · Ph 3 NCT04484415 · Ph 3 NCT03272659 · Ph 2 NCT03058705 · not/applicable NCT02560584 · Ph 3 NCT02367547 · Ph 1/2 NCT01551407 · Ph 2 NCT01282515 · Ph 2/3 NCT01256424 · Ph 2 NCT01344902 · Ph 1/2 NCT00785694 · Ph 4 NCT00285701 · Ph 1/2 NCT00233402 · Ph 3 NCT00052637 · Ph 3

200120022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027202820292030

Phase	Registry id	Dates	Indication	Sponsor	Status	Outcome
Phase 1/23 trials
Phase 1/2	NCT02367547	Mar 2015 → Sep 2018	basal cell carcinoma	Joint Authority for Päijät-Häme Social and Health Care	Unknown	No outcome recorded
Phase 1/2	NCT01344902	Feb → Oct 2009	colon carcinoma	Photocure	Terminated	No outcome recorded
Phase 1/2	NCT00285701	Jul 2006 → Nov 2007	colorectal cancer	Photocure	Completed	No outcome recorded
Phase 24 trials
Phase 2	NCT07669363	Jul 2026 → Jun 2029 expected	cervical intraepithelial neoplasia, human papilloma virus infection	Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University	Not yet recruiting	No outcome recorded
Phase 2	NCT03272659	Apr → Dec 2018	colorectal cancer	Dr. Te Vuong	Withdrawn	No outcome recorded
Phase 2	NCT01551407	Dec 2011 → Jun 2012	urinary bladder cancer	Photocure	Terminated	No outcome recorded
Phase 2	NCT01256424	Apr 2011 → Sep 2012	cervical intraepithelial neoplasia	Photocure	Completed	No outcome recorded
Phase 2/31 trial
Phase 2/3	NCT01282515	Aug 2011 → Oct 2014	lichen planus	Oslo University Hospital	Completed	No outcome recorded
Phase 36 trials · 3 met primary
Phase 3	NCT06525571	Dec 2024 → Jan 2027 expected	urinary bladder cancer	Johns Hopkins University	Recruiting	No outcome recorded
Phase 3	NCT05600322	Nov 2022 → Jul 2023	urinary bladder cancer	Photocure	Completed	Met primary
Phase 3	NCT04484415	Nov 2020 → Dec 2023	cervical intraepithelial neoplasia grade 2/3	Asieris Pharmaceuticals	Unknown	No outcome recorded
Phase 3	NCT02560584	Oct 2015 → Apr 2017	urinary bladder cancer	Photocure	Completed	Met primary
Phase 3	NCT00233402	Jan 2005 → Jul 2008	urinary bladder cancer	Photocure	Completed	Met primary
Phase 3	NCT00052637	Sep 2001 → May 2002	urinary bladder cancer	Photocure	Completed	No outcome recorded
Phase 42 trials
Phase 4	NCT05962541	Dec 2025 → Dec 2028 expected	non-invasive bladder urothelial carcinoma	University of Roma La Sapienza	Recruiting	No outcome recorded
Phase 4	NCT00785694	Dec 2008 → Aug 2011	urinary bladder cancer	GE Healthcare	Withdrawn	No outcome recorded
Phase not applicable1 trial
—	NCT03058705	Nov 2017 → Jul 2018	urinary bladder cancer	Edward Messing	Completed	No outcome recorded
Comparator or background therapy4 trials
Phase 1	NCT01050309 Comparator	Nov → Dec 2009	—	Photocure	Completed	No outcome recorded
Phase 1/2	NCT00369018 Comparator	Aug 2006 → Jul 2009	dysplasia of cervix	Photocure	Completed	No outcome recorded
Phase 2	NCT00708942 Comparator	Jan 2009 → Jan 2012	cervical intraepithelial neoplasia	Photocure	Terminated	No outcome recorded Stop: Enrollment
Phase 3	NCT00412971 Comparator	Apr 2005 → Oct 2008	urinary bladder cancer	Photocure	Completed	No outcome recorded

News releases announcing trial results or a regulatory action · 95

Date	Issuer	Release
2026-10-09	Photocure	Results New publication modelling Bladder Cancer Recurrence and Progression Using the Blue Light Cystoscopy with Cysview Registry photocure.com ↗ On multivariable analysis, HGTa (HR 1.60) and HGT1 (HR 1.94) tumors were associated with increased risk of recurrence.
2026-08-11	Photocure	Results Cost neutrality of BLC versus WLC in a real-world setting demonstrated by new OPTUM study in the U.S. photocure.com ↗ During the baseline period, prior to index cystoscopy, BLC patients had higher prevalence of CIS detection than WLC per reimbursement claims.
2026-02-27	Photocure	Regulatory Photocure partner Asieris announces that EMA has accepted Marketing Authorization Application for CEVIRA in Europe photocure.com ↗
2026-01-12	Photocure	Results New publication of Hexvix trial data from China: blue light cystoscopy with Hexvix significantly improves the detection of bladder cancer using modern HD equipment photocure.com ↗ Compared with WLC, the proportion of patients with additional bladder cancer lesions detected by BLC was 43.3% (p＜0.0001).
2025-04-29	Photocure	Results Bladder Cancer presentations at AUA2025: Blue Light Cystoscopy improves risk stratification and informed decision making photocure.com ↗ A total of 201 (7%) patients had at least one malignant lesion detected exclusively by BLC while having a negative WLC.
2025-03-14	Photocure	Results New BRAVO Study Publication Reinforces Clinical Benefits of BLC in Reducing Risk of Bladder Cancer Recurrence photocure.com ↗ Results of the real-world evidence study show that BLC was associated with a statistically significant 38% reduction in risk of recurrence compared to white light cystoscopy (WLC) use alone in a predominantly high-risk NMIBC patient cohort.
2025-02-17	Photocure	Results Bladder Cancer: Upstaging and risk mitigation with Blue Light Cystoscopy in NMIBC featured at ASCO GU 2025 photocure.com ↗ A total of 201 (7%) patients had at least one malignant lesion detected exclusively by BLC while having a negative WLC.
2024-11-05	Photocure	Regulatory Photocure Partner Asieris announces Marketing Approval by the National Medical Products Administration for Hexvix in China photocure.com ↗ Jiangsu Yahong Meditech Co., Ltd (hereinafter referred to as the "Company") has received the "Drug Registration Certificate" issued by the National Medical Products Administration, approving the marketing of the company's APL-1706 (Hexaminolevulinate Hydrochloride For Intravesical Solution).
2024-08-30	Photocure	Results New publication: blue light cystoscopy shows potential to facilitate the diagnosis of CIS in the upper urinary tract photocure.com ↗ The article describes the first upper tract blue light cystoscopy during which the physicians were able to diagnose upper tract carcinoma in situ (CIS).
2024-05-12	Photocure	Regulatory Photocure Partner Asieris announces New Drug Application acceptance for regulatory review of Cevira in China photocure.com ↗ Photocure ASA (OSE: PHO), the Bladder Cancer Company, announces that its partner Asieris Pharmaceuticals (SSE: 688176) communicated today that the National Medical Products Administration (NMPA) has accepted its new drug application (NDA) for the regulatory review of Cevira ® (APL-1702, Hexaminolevulinate Hydrochloride Ointment Photodynamic Therapy System) for potential marketing authorization in China.
2024-05-07	Photocure	Results Bladder Cancer: Long-Term Benefits of Blue Light Cystoscopy and Enhanced Detection with HD Technology Unveiled at AUA 2024 photocure.com ↗ The results of this study confirm that BLC use is associated with positive and statistically significant impacts on these outcomes.
2024-03-28	Photocure	Results New Publication: Racial Difference in Detection Rate of Bladder Cancer Using Blue Light Cystoscopy photocure.com ↗ The sensitivity of WLC, BLC, and the combination of both for any malignant lesion was 88.7%, 95.8% and 99%, respectively, in the total cohort (P<0.001).
2024-03-22	Photocure	Regulatory Canadian Health Authorities approve updated and expanded label for Cysview photocure.com ↗ Photocure ASA (OSE: PHO), the Bladder Cancer Company, announces the reception of the Note of Compliance from Health Canada this week, approving the updated Product Monograph for Cysview ® in Canada.
2024-01-29	Photocure	Results Photocure Partner Asieris presented clinical trial and real-world data on Hexvix in China at ASCO GU 2024 photocure.com ↗ Both the RCT and RWS confirmed that Blue Light Cystoscopy with Hexvix demonstrated superior detection of bladder cancer in the Chinese population compared to WLC, especially in the CIS population, with good tolerability.
2023-11-29	Photocure	Regulatory Photocure Partner Asieris announces New Drug Application acceptance for regulatory review of Hexvix in China photocure.com ↗ Photocure ASA (OSE: PHO), the Bladder Cancer Company, announces that its partner Asieris Pharmaceuticals (SSE: 688176) communicated today that the National Medical Products Administration (NMPA) accepted the new drug application (NDA) for Hexvix ® (APL-1706) in China.
2023-11-06	Photocure	Results New publication: immunological impact of Blue Light Cystoscopy with hexaminolevulinate in bladder cancer photocure.com ↗ The findings suggest that BLC-guided TURBT with the metabolic photosensitizer HAL which has a preferential tumor accumulation alters the expression of immune cells of both the adaptive and innate immune system compared to WLC-guided TURBT.
2023-10-12	Photocure	Results Positive Results for Hexvix Phase III Clinical Trial in China Presented at the SIU 2023 Congress photocure.com ↗ Press Release – Oslo, Norway, October 12, 2023: Photocure ASA (OSE: PHO), the Bladder Cancer Company, announces that its partner Asieris Pharmaceuticals (SSE: 688176) has today unveiled the results of its Hexvix ® (APL-1706) Phase III clinical trial in China.
2023-08-11	Photocure	Results Photocure Partner Asieris confirms Hexvix Phase III clinical trial in China meets endpoint photocure.com ↗
2023-05-11	Photocure	Results New publication reinforces the clinical benefits of Blue Light Cystoscopy demonstrating an improvement in detection of CIS photocure.com ↗ It demonstrates how Blue Light Cystoscopy (BLC ® ) detected significantly more CIS (41.2% vs 11.8%, p=0.0491) compared to white light cystoscopy (WLC) with 5.8% upstaged to muscle invasive bladder cancer.
2023-05-04	Photocure	Results New Publication: clinical data demonstrates reduced risk of recurrence in non-muscle invasive bladder cancer with the use of BLC photocure.com ↗ The data demonstrated a significant decrease in the risk of recurrence and prolonged time to recurrence following Blue Light cystoscopy (BLC ® ) with Cysview ® compared to White Light cystoscopy (WLC) alone.
2023-05-02	Photocure	Results Photocure: Nordic registry clinical data and multiple scientific programs at AUA 2023 Congress reinforce the benefits of Blue Light Cystoscopy photocure.com ↗ The study results showed that flexible blue light cystoscopy with Hexvix ® /Cysview ® , as an adjunct to white light cystoscopy for surveillance of NMIBC, improves the detection of malignant lesions.
2023-03-14	Photocure	Results Photocure: New data presented at EAU 2023 highlight the effects of blue light cystoscopy in bladder cancer photocure.com ↗ Preliminary findings suggest that BLC-guided TURBT changes the expression of immune cells of both the adaptive and innate immune system compared to WLC-guided TURBT.
2023-02-20	Photocure	Results Clinical data presented at ASCO GU demonstrates reduced risk of recurrence in non-muscle invasive bladder cancer with the use of BLC photocure.com ↗ The clinical data demonstrated a significant decrease in the risk of recurrence & longer time to recurrence following Blue Light cystoscopy (BLC ® ) with Cysview ® compared to White Light cystoscopy (WLC) alone.
2023-01-03	Photocure	Results New study publication reinforces the clinical benefits of Blue Light Cystoscopy in the ASC setting; supports ongoing initiatives to further improve reimbursement photocure.com ↗ In the published clinical and health economic model, use of BLC resulted in the identification of 5 additional NMIBC recurrences compared to white light cystoscopy alone.
2022-12-15	Photocure	Results Bladder Cancer: New Meta-analysis photocure.com ↗ The analysis shows favorable outcomes on recurrence, recurrence free survival and progression for blue light (HAL-guided) cystoscopy compared to white light cystoscopy.
2022-12-05	Photocure	Results New Evidence: Positive Impact of Blue Light Cystoscopy on Recurrence in Bladder Cancer Presented at the Annual SUO Meeting photocure.com ↗ The overall risk of recurrence was significantly lower following BLC compared to WLC alone (Hazard Ratio (HR) 0.33; 95% Confidence Interval (CI) 0.28-0.40, p-value=0<.0001).
2022-10-04	Photocure	Results Data presented at the International Bladder Cancer Network (IBCN) meeting demonstrate a reduction in the risk of recurrence with the use of BLC photocure.com ↗
2022-09-20	Photocure	Results New study demonstrates that tumor removal in the outpatient setting is as good as TURBT under general anesthesia photocure.com ↗ Laser III results demonstrate the non-inferiority of outpatient laser-mediated destruction of bladder tumors in conjunction with blue light cystoscopy (BLC ® ) and Hexvix ® versus inpatient BLC TURBT* under general anesthesia.
2022-03-11	Photocure	Regulatory Photocure Partner Asieris announces CDE Approval for Hexvix Clinical Real-World Evidence Study in China photocure.com ↗ Asieris announced today that the Hainan Provincial Medical Products Administration, in accordance with advice from the National Medical Products Administration Center for Drug Evaluation (CDE), has approved the inclusion of Hexvix in the clinical real-world evidence pilot study.
2022-02-28	Photocure	Results Photocure Announces the Publication of Pre-Clinical Study Results Supporting the Anti-tumor Effect of Hexaminolevulinate with Blue Light in Bladder Cancer model photocure.com ↗
2022-02-11	Photocure	Regulatory Photocure Partner Asieris announces Approval to conduct a Phase III Clinical Trial for Hexvix in China photocure.com ↗
2021-10-29	Photocure	Results Full publication from U.S. registry now available, investigating utility of Blue Light Cystoscopy after bladder cancer treatment with BCG photocure.com ↗ Detection of recurrences with white light only in the same patients would have been 39.4% (n=111/282) instead of 45.0% (n=127/282) with BLC.
2021-10-12	Photocure	Results Full publication from U.S. registry now available, highlighting the Role of Blue Light Cystoscopy in Detecting Invasive Bladder Tumor photocure.com ↗ Of the 3514 lesions (1257 unique patients), 818 (23.2%) lesions were only detected under blue light (BL).
2021-09-15	Photocure	Results Presentations of Blue Light Flexible Cystoscopy Study Results and Bladder Cancer Surgical Techniques featured at AUA 2021 photocure.com ↗ BLFC identified all 23 malignancies, demonstrating 100% sensitivity for cancer detection in this cohort, whereas analysis by cytology identified only 3 of the 23 confirmed malignancies.
2021-08-16	Photocure	Regulatory Photocure announces regulatory approval of Hexvix in Chile photocure.com ↗ Photocure ASA (OSE: PHO), the Bladder Cancer Company, announces that the Marketing Authorization for Hexvix ® in Chile has been granted.
2021-07-13	Photocure	Results Photocure: New data presented at EAU 2021 highlight the effects of blue light cystoscopy on detection and recurrence of bladder cancer photocure.com ↗ In the patients diagnosed with bladder cancer, thirteen BCG-refractory tumors were detected with WL, and 14 additional BCG-refractory tumors were detected with PDD, which lead to a change in management of their NMIBC.
2021-06-23	Photocure	Results New article published in Urologic Oncology: Macro and Microeconomics of Blue Light Cystoscopy with Cysview in Non-Muscle Invasive Bladder Cancer photocure.com ↗ In a simulated facility with 50 newly diagnosed bladder cancer patients, the model illustrates that the additional use of BLC in surveillance identified 9 additional recurrences over two years compared to WLC alone.
2021-06-03	Photocure	Results Bladder Cancer: New study in the U.S. reports on association between smoking and risk of recurrence photocure.com ↗ This analysis of more than 700 patients shows that smoking status was not significantly associated with recurrence in patients with predominantly high-risk recurrent NMIBC managed with photodynamic enhanced cystoscopy.
2021-05-18	Photocure	Regulatory Photocure announces Hexvix regulatory filing accepted for review in Chile with Fast Track designation photocure.com ↗ the Marketing Authorization Application (“MAA”) for Hexvix ® has been accepted for regulatory review.
2020-12-07	Photocure	Results New abstracts on the use of Blue Light Cystoscopy with Cysview presented at SUO photocure.com ↗ The Budget Impact Model supports the favorable cost-benefit of blue light procedures including in the office setting, while reaffirming its superiority in detection of non-muscle-invasive bladder cancer compared to white light alone.
2020-10-16	Photocure	Results New data analysis on Blue Light Cystoscopy efficiency presented at the virtual BLADDR 2020 congress photocure.com ↗ It demonstrates that flexible Blue Light Cystoscopy helped resolve a substantial amount of cases by complete removal on-site or direct referral to intravesical treatment, providing increased efficacy to manage non-muscle-invasive bladder cancer (NMIBC) in the office setting.
2020-05-16	Photocure	Results AUA abstracts further support role for Cysview[®] in the office setting photocure.com ↗ A total of 55 invasive lesions, of the 494 invasive lesions detected, were detected only by blue light cystoscopy.
2019-12-19	Photocure	Results Photocure: Reduced recurrence after flexible Blue Light Cystoscopy with Hexvix® in surveillance ‒ New Publication of study results photocure.com ↗ Use of flexible Blue Light Cystoscopy at the first follow-up after TURBT* reduced the risk of tumor recurrence by 33% compared to white light alone.
2019-12-19	Photocure	Results Photocure: Reduced recurrence after flexible Blue Light Cystoscopy with Hexvix® in surveillance ‒ New Publication of study results photocure.com ↗ Use of flexible Blue Light Cystoscopy at the first follow-up after TURBT* reduced the risk of tumor recurrence by 33% compared to white light alone.
2019-11-18	Photocure	Results Photocure: First trial demonstrating reduced recurrence after flexible Blue Light Cystoscopy with Hexvix[®] in surveillance photocure.com ↗ Throughout the following 8 months after randomization, only 117 patients in the BLC group had at least one tumor recurrence compared to 143 patients in the control group (P= 0.049).
2019-10-28	Photocure	Results Photocure: New data from Hexvix® trials presented at the BLADDR 2019 congress photocure.com ↗ The results of the study indicate for the first time that a treatment effect could be related to immunogenic cell death responses and anti-tumor immune cell activation.
2019-07-05	Photocure	Results Implementing Blue Light Flexible Cystoscopy in Bladder Cancer Surveillance photocure.com ↗ In a clinical study, around 1 in 5 confirmed malignancies were detected only by flexible BLC (p < 0.0001)1 and the introduction of flexible BLC for routine surveillance post-TURBT is supported by consensus among bladder cancer specialists2.
2019-06-11	Photocure	Results HEXVIX® AT NUF 2019: FOCUS ON THE PATIENT EXPERIENCE photocure.com ↗ 10 out of 12 patients described that they experienced emotional and physical support because it was the same nurse who handled all information and assignment before, during and after the BLC with flexible cystoscope procedure.
2019-05-06	Photocure	Results Photocure ASA: Expanded role for Cysview® in treating bladder cancer patients - presented at the 2019 AUA Annual Meeting photocure.com ↗ 75% of patients reported that BLC with Cysview added value to their disease maintenance
2019-04-30	Photocure	Results Photocure - Better patient outcomes for patients who received Hexvix® photocure.com ↗ The 5-year CSS was 90.9% for the BLC group and 73.8% for the WLC group, and 5-year OS was 74.5% and 55.8% for BLC and WLC groups, respectively (p= 0.042, 0.038).
2019-03-19	Photocure	Results Photocure ASA: Hexvix® /Cysview® with Flexible Cystoscopy improves Bladder Cancer detection. Data presented at the EAU congress in Barcelona. photocure.com ↗ Patient Reported Outcomes results from the trial demonstrated a positive patient evaluation of Hexvix® / Cysview® as well as more than 50% willing to pay $100 or more for the procedure.
2019-03-19	Photocure	Results Hexvix® / Cysview® with Flexible Cystoscopy improves Bladder Cancer detection. Data presented at the EAU congress in Barcelona. photocure.com ↗ Patient Reported Outcomes results from the trial demonstrated a positive patient evaluation of Hexvix® / Cysview® as well as more than 50% willing to pay $100 or more for the procedure.
2018-02-16	Photocure	Regulatory Photocure Announces U.S. FDA Approval of New Indications for Blue Light Cystoscopy with Cysview® photocure.com ↗ Oslo, Norway, February 16, 2018 Photocure ASA (OSE: PHO), announced today that the U.S. Food and Drug Administration (FDA) approved its supplemental new drug application (sNDA) to extend the indication for Blue Light Cystoscopy (BLC(TM)) with Cysview ® to include Flexible Cystoscopes, which are used in the ongoing surveillance of patients with bladder cancer.
2017-12-08	Photocure	Results Photocure ASA: Landmark Blue Light Cystoscopy with Cysview® study is published in the Journal of Urology photocure.com ↗ In 20.6 percent of patient's recurrence was seen only with BLC with Cysview and missed with WLC (p<0.0001).
2017-12-01	Photocure	Results Photocure ASA: Blue Light Flexible Cystoscopy with Cysview® Phase 3 study: New data presented at Society of Urological Oncology photocure.com ↗ In addition, an abstract on Patient Reported Outcomes was presented from the same Phase 3 study which demonstrated a positive impact on anxiety.
2017-10-23	Photocure	Results Photocure ASA: BLC(TM) with Cysview®/Hexvix® real World Data presented at the Société Internationale d'Urologie 2017 Annual meeting photocure.com ↗ Data from the registry study, which is the largest US Bladder Cancer Registry Study, showed that BLC with Cysview resulted in an upstaging or upgrading of tumor with change in patient management in 13% of patients.
2017-10-18	Photocure	Regulatory Photocure ASA: FDA grants priority review for Cysview® supplemental New Drug Application (sNDA) photocure.com ↗ Oslo, Norway, October 18, Photocure ASA (OSE: PHO) announced today that the U.S. Food and Drug Administration (FDA) has accepted the supplemental New Drug Application (sNDA) for Cysview ® on a priority review basis.
2017-08-18	Photocure	Results Photocure ASA: Blue Light Cystoscopy with Hexvix® reduces recurrence rate at 3 years in real-life experience study photocure.com ↗ The overall recurrence rates at 3 years were significantly less in patients who received BLC (TM) with Hexvix ® (39.0%) compared to an optimized White Light Cystoscopy (WLC) resection (53.3%; p=0.02).
2017-08-16	Photocure	Regulatory Photocure files supplemental New Drug Application with FDA for Blue Light Cystoscopy (BLC(TM)) with Cysview® photocure.com ↗ Photocure ASA (OSE: PHO) announced today that it has filed a supplemental new drug application (sNDA) with the U.S. Food and Drug Administration (FDA)
2017-07-31	Photocure	Results Photocure ASA: First European study to show that Blue Light Flexible Cystoscopy with Hexvix® can replace conventional follow up of CIS patients photocure.com ↗ The results demonstrate that bladder examinations and biopsies of lesions performed with Blue Light Flexible Cystoscopy in the outpatient setting are equivalent to those performed in the inpatient setting with rigid scopes in the operating room and the patient under general anaesthesia.
2017-07-17	Photocure	Regulatory Photocure ASA : UPDATE ON MEDICARE REIMBURSEMENT FOR BLUE LIGHT CYSTOSCOPY WITH CYSVIEW® photocure.com ↗
2017-05-15	Photocure	Results Photocure ASA: Positive data from Phase 3 US Blue Light Cystoscopy with Cysview® study presented at AUA 2017 meeting in Boston photocure.com ↗
2017-05-12	Photocure	Results Photocure ASA: Phase 3 study investigating Blue Light Flexible Cystoscopy with Cysview® in surveillance setting meets primary endpoint photocure.com ↗ Photocure ASA (Photocure, PHO:OSE), today announced that a Phase 3 trial investigating Blue Light Flexible Cystoscopy (BLFC(TM)) with Cysview®/Hexvix® in the surveillance setting met the study primary end point.
2016-12-05	Photocure	Results Photocure ASA: US registry shows that Blue Light Cystoscopy (BLC) with Cysview®/Hexvix® leads to improved detection and classification of bladder cancer photocure.com ↗ BLCC as an adjunct to white light cystoscopy (WLC) resulted in the detection of an additional 151 lesions and 45 patients uniquely with the addition of blue light.
2016-11-28	Photocure	Results Photocure ASA: Blue Light Cystoscopy (BLC) with Cysview®/Hexvix® decreases the risk of progression and recurrence in bladder cancer photocure.com ↗ This review, which was sponsored by the US Agency for Healthcare Research (AHRQ), concluded that Blue Light Cystoscopy with Cysview ® /Hexvix ® was associated with decreased risk of progression and recurrence of non-muscle invasive bladder cancer versus White Light Cystoscopy alone.
2016-09-28	Photocure	Results Photocure: Repeat use of Blue Light Cystoscopy with Hexvix®/Cysview® shows excellent tolerability photocure.com ↗ Photocure ASA announced today that a study published on-line in the peer reviewed Journal of Urology, shows that there is no significant statistical difference in the frequency or grade of adverse events in patients having one Blue Light Cystoscopy with Cysview ® (BLCC) versus repeat BLCC procedures.
2016-09-12	Photocure	Results Photocure ASA: Data published in World Journal of Urology show that Blue Light Cystoscopy with Hexvix® significantly improves detection of NMIBC photocure.com ↗ The results of this large 30 center study demonstrate that Blue Light Cystoscopy (BLC) with Hexvix significantly improves the detection of NMIBC versus the standard procedure of white light (WLC) alone in routine clinical practice in Germany.
2016-08-24	Photocure	Regulatory Photocure: Hexvix® marketing authorization approval in Australia photocure.com ↗ Photocure ASA (OSE: PHO), announces that its partner and exclusive distributor, Juno Pharmaceuticals Pty Ltd, have received marketing authorization approval (MAA) for Hexvix in Australia.
2016-08-11	Photocure	Regulatory Photocure ASA: CYSVIEW® GRANTED FDA APPROVAL OF NEW PREFILLED SYRINGE PRODUCT PACKAGING photocure.com ↗ Photocure ASA (OSE: PHO), announces today that the U.S. Food & Drug Administration (FDA) has granted approval for an improved and more user-friendly packaging for Cysview.
2016-08-02	Photocure	Results Photocure: New meta-analysis shows that BLC with Hexvix®/Cysview® significantly reduces rate of progression in bladder cancer photocure.com ↗ In this meta-analysis, the rate of progression was significantly lower in patients treated with BLC with Hexvix ® versus WLC alone.
2016-05-09	Photocure	Results Photocure ASA: Positive clinical data on BLC with Cysview®/Hexvix® presented at AUA photocure.com ↗ The addition of BL to standard WLC increased the detection rate by 12% in any papillary lesions and 46% for CIS.
2016-04-26	Photocure	Results Photocure ASA: New analysis shows Hexvix®/Cysview® significantly prolongs time to progression of bladder cancer photocure.com ↗ Using the new IBCG definition, overall time to disease progression was significantly longer in the BLC with Hexvix/Cysview group (p=0.05).
2016-03-14	Photocure	Results Photocure ASA Hexvix® data presented during the European Association of Urology congress photocure.com ↗ Hexvix real world evidence show improved recurrence free survival and health care savings
2015-09-04	Photocure	Regulatory Photocure announces submission of application for Hexvix® marketing authorization in Australia photocure.com ↗ The partnership with Juno Pharmaceuticals is progressing well and we are pleased that they have reached this significant milestone with the filing of the MAA.
2015-03-23	Photocure	Results PHOTOCURE: HEXVIX® BLUE-LIGHT FLEXIBLE CYSTOSCOPY IN THE OUTPATIENT SETTING: PRESENTATION AT EAU ANNUAL MEETING photocure.com ↗ The research, presented as five video case presentations by Dr. Reza Zare, Head of Urology at Bærum Hospital, Norway, shows how Hexvix blue-light flexible cystoscopy achieved high-quality images, with improved visibility of tumors compared with standard white-light flexible cystoscopy alone.
2015-01-29	Photocure	Results Photocure ASA: New data provide evidence that Hexvix® can improve the overall survival in bladder cancer patients photocure.com ↗ These data indicate for the first time that improved patient management with HAL-guided TUR-BT can make a difference in outcomes even for those bladder cancer patients who later progress to advanced disease and require radical cystectomy.
2014-11-04	Photocure	Results Photocure: Cevira® data published in American Journal of Obstetrics & Gynecology photocure.com ↗ Cevira, a novel and easy to use integrated drug-delivery device, demonstrated significant and sustained efficacy in the eradication of oncogenic HPV infections and precancerous lesions in CIN2 patients as compared to placebo.
2014-07-10	Photocure	Results Photocure ASA: Expert Recommendations on the Clinical and Cost Effectiveness of Hexvix® blue-light cystoscopy published in European Urology photocure.com ↗ The panel concluded that Hexvix blue-light cystoscopy is a clinically effective and cost-effective tool for improving NMIBC detection and management, thereby reducing the burden of disease for patients and costs to the healthcare system.
2013-11-06	Photocure	Results Photocure to present data on Cevira® at the Eurogin 2013 Congress, Florence, Italy photocure.com ↗ This was further supported by high clearance of the highest risk oncogenic HPV subtypes 16 and 18 in the CIN2 cohort, of 83% vs 33% at six months.
2013-05-06	Photocure	Results PHOTOCURE: DATA ON HEXVIX®/CYSVIEW® TO BE PRESENTED AT AMERICAN UROLOGICAL ASSOCIATION, SAN DIEGO, USA photocure.com ↗ The data indicate that the greater sensitivity of Hexvix/Cysview PDD allows greater detection of tumors.
2013-03-18	Photocure	Results NEW META-ANALYSIS CONFIRMING THE CLINICAL BENEFIT OF HEXVIX®-GUIDED BLUE LIGHT CYSTOSCOPY PRESENTED AT EUROPEAN ASSOCIATION OF UROLOGY (EAU) CONGRESS, MILAN photocure.com ↗ The meta-analysis, which was conducted on raw data from eight Hexvix prospective studies and included a total of 1,293 patients, confirms previous studies and indicates that Hexvix cystoscopy significantly improves the detection of bladder cancer and reduces the risk of recurrence.
2013-03-11	Photocure	Results POSITIVE CEVIRA® DATA PRESENTED AS LATE BREAKER AT 2013 SOCIETY OF GYNECOLOGIC ONCOLOGY ANNUAL MEETING ON WOMEN'S CANCER photocure.com ↗ Initial three month results from the phase 2b study show that the optimal dose of Cevira, 5%, demonstrated a statistically significant lesion response compared to placebo in patients with precancerous CIN2 lesions, 95% vs 57% respectively, (p<0.01).
2013-02-15	Photocure	Regulatory PHOTOCURE ANNOUNCES EXPANSION OF HEXVIX® INDICATION photocure.com ↗ The approved expanded indication recommends use of Hexvix blue light fluorescence cystoscopy as an adjunct to white light cystoscopy in the diagnosis and management of bladder cancer.
2012-12-05	Photocure	Results PHOTOCURE ANNOUNCES POSITIVE RESULTS OF CEVIRA® STUDY photocure.com ↗ The optimal dose of Cevira, 5%, demonstrated a statistically significant lesion response compared to placebo in patients with precancerous CIN2 lesions, 95% vs 57% respectively, (p<0.01).
2012-05-22	Photocure	Results PHOTOCURE TO PRESENT DATA ON IMPACT OF HEXVIX®/CYSVIEW® ON LONG TERM RECURRENCE RATES AT AMERICAN UROLOGICAL ASSOCIATION ANNUAL MEETING, ATLANTA, USA photocure.com ↗ The data on Hexvix/Cysview, from a long term follow-up study in 551 patients, indicates that Hexvix cystoscopy significantly improves time to recurrence of bladder cancer.
2012-02-24	Photocure	Results Photocure ASA: Data on impact of Hexvix® on long term recurrence rates to be prestented at European Association of Urology (EAU) Congress, Paris photocure.com ↗ The data on Hexvix, from a long term follow-up study in 551 patients, demonstrates that Hexvix cystoscopy significantly improves bladder cancer recurrence free survival.
2011-05-12	Photocure	Results Photocure - Hexvix®/Cysview(TM) demonstrates long term benefit -Results from 5.5 year follow up of recurrence of bladder cancer photocure.com ↗ A statistically significant difference was observed between the recurrence free survival curves, p=0.04.
2011-03-18	Photocure	Results Photocure - British Journal of Urology publishes paper on Hexvix® photocure.com ↗ The results of the trial demonstrate that Hexvix identified lesions (including residual tumors) that were not detected with white light alone in 49% of the patients.
2011-01-26	Photocure	Results Succesfull Phase II results for Cevira photocure.com ↗ The results showed a complete removal of intracervical lesions in over 50% of patients enrolled in the trial.
2010-10-05	Photocure	Results New publication on Hexvix demonstrating that Hexvix guided fluorescence cystoscopy reduces recurrence in patients with non-muscle invasive bladder cancer photocure.com ↗ This publication shows that Hexvix guided fluorescence cystoscopy (Hexvix ® ), as an adjunct to conventional white-light cystoscopy, improves the detection of bladder cancer and reduces the rate of early tumour recurrence, compared with white-light cystoscopy alone.
2010-10-04	Photocure	Results Photocure announces successful Phase II results for Cevira(TM) photocure.com ↗ The preliminary results from a multi-centre placebo controlled Phase II study of 70 patients with mild cervical abnormalities showed a three month response rate of 71% for Cevira(TM) versus 43% in the control group.
2010-01-13	Photocure	Regulatory Photocure - Hexvix® receives reimbursement approval in Germany photocure.com ↗ Photocure ASA (OSE:PHO) today announces that Hexvix ® has received reimbursement of Hexvix in Germany.
2009-12-31	Photocure	Regulatory Photocure received positive response from FDA on the New Drug Application (NDA) for Hexvix® for detection of bladder cancer photocure.com ↗ The Food and Drug Administ ration (FDA) has informed Photocure that the new drug application (NDA) for Hexvix for detection of non-invasive papillary bladder cancer may be approved pending approval of the PMA for the Karl Storz photodynamic diagnosis system and final agreements between Photocure and FDA on labeling, and post-marketing commitments.
2009-12-17	Photocure	Regulatory FDA Advisory Committee voted favourably to Photocures new drug application in USA for Hexvix photocure.com ↗ ODAC recommended Hexvix as an adjunct to white light cystoscopy in the detection of non-muscle invasive papillary cancer of the bladder.
2009-03-19	Photocure	Results FLUORESCENCE CYSTOSCOPY IMPROVES DETECTION AND RESECTION OF PAPILLARY BLADDER CANCER LESIONS AND REDUCES EARLY RECURRENCES photocure.com ↗ A within patient comparison of 278 patients with non-muscle invasive papillary bladder tumors (Ta/T1) randomized to Hexvix cystoscopy and TURB showed that in 16.9% of these patients at least one additional Ta or T1 tumor was detected compared to white light cystoscopy.

All press releases naming this drug 145 releases

Date	Issuer	Release
Show all 145 releases opens the full record — a long page

Evidence & citations 16 cited values

Every value below carries the sentence it was read from. 27 sources stand behind the page.

Field	Value	Cited text
Known as	hexaminolevulinate	“Cevira, an integrated drug-delivery and light-delivery device for hexaminolevulinate photodynamic therapy” PMID 35667715 ↗ Jun 2022 12 “The drug is hexaminolevulinate hydrochloride (HAL) 5% ointment.” NCT07669363 ↗ “hexaminolevulinate (HAL) photodynamic therapy (PDT)” NCT01256424 ↗ NCT00052637 ↗ NCT01344902 ↗ NCT00785694 ↗ NCT00708942 ↗ NCT00285701 ↗ NCT00369018 ↗ NCT02560584 ↗ NCT01282515 ↗ Show 2 more sources
Known as	Cysview	ClinicalTrials.gov intervention name — accepted as the source's own label NCT03272659 ↗ 1 NCT06525571 ↗
Known as	Cysview kit	ChEMBL registry synonym — accepted as the source's own label CHEMBL1201784 ↗
Known as	HAL	“In this study hexaminolevulinate (HAL) will be administered locally as a photosensitiser, using different doses to find the optimal imaging conditions as well as making patient...” NCT00285701 ↗ 8 “This study will explore topical application of methyl aminolevulinate (MAL) and hexaminolevulinate (HAL) of the cervix for photodynamic therapy using red light (630 nm).” NCT00369018 ↗ “Safety of repeat blue light cystoscopy with hexaminolevulinate (HAL) in the management of bladder cancer: Results from a phase III, comparative, multi-center study.” PMID 35750559 ↗ Jun 2022 “using hexaminolaevulinate (HAL: Hexvix®, Photocure, Norway) for photodynamic diagnosis during 12 months of follow-up.” PMID 21414125 ↗ Mar 2011 “Drug: hexaminolevulinate (HAL) Suppository HAL 100 mg for 3-7 hours application” NCT00708942 ↗ “The drug is hexaminolevulinate hydrochloride (HAL) 5% ointment.” NCT07669363 ↗ “selective photosensitizer precursor hexaminolevulinate (HAL)” PMID 18197583 ↗ Jan 2008 “hexaminolevulinate (HAL) photodynamic therapy (PDT)” NCT01256424 ↗ “Drug: hexaminolevulinate (HAL)” NCT01050309 ↗
Known as	HAL hydrochloride	“Patients received 1 or 2 topical treatments of HAL hydrochloride 0.2%, 1%, 5%, and placebo ointment” PMID 25467012 ↗ Oct 2014
Known as	hexaminolaevulinate	“using hexaminolaevulinate (HAL: Hexvix®, Photocure, Norway) for photodynamic diagnosis during 12 months of follow-up.” PMID 21414125 ↗ Mar 2011
Known as	Hexaminolevulinate HCL	ClinicalTrials.gov intervention name — accepted as the source's own label NCT03058705 ↗
Known as	hexaminolevulinate hydrochloride	“The drug is hexaminolevulinate hydrochloride (HAL) 5% ointment.” NCT07669363 ↗ 1 NCT05600322 ↗
Known as	Hexvix	“reconstituted hexyl 5-aminolevulinate (Hexvix®)” NCT00052637 ↗ 3 NCT00233402 ↗ NCT01551407 ↗ NCT00412971 ↗
Known as	Hexyl aminolevulinate hcl	ChEMBL registry synonym — accepted as the source's own label CHEMBL1201784 ↗
Known as	Hexylaminolevulinate	ClinicalTrials.gov intervention name — accepted as the source's own label NCT02367547 ↗
Known as	P-1026	ChEMBL registry synonym — accepted as the source's own label CHEMBL1201784 ↗
Known as	P-1206	ChEMBL registry synonym — accepted as the source's own label CHEMBL1201784 ↗
Modality	Diagnostic / imaging agent	“hexaminolevulinate fluorescence cystoscopy” PMID 20850152 ↗ Sep 2010
Modality	Small molecule	— CHEMBL1201784 ↗
Route	Other	“Patients undergo bladder catheterization and instillation of reconstituted hexyl 5-aminolevulinate (Hexvix®).” NCT00052637 ↗