A Multicenter Study to Assess the Feasibility of Gleolan (ALA / Aminolevulinic Acid HCl) in Pediatric Brain Tumor Patients After Delayed Administration

This clinical trial focuses on pediatric patients aged 2 up to 18 years of age with a new or recurrent pediatric brain tumor, suspected to be either a high-grade or low-grade glioma, and scheduled for surgical removal. 5-aminolevulinic acid (5-ALA) is FDA-approved for improving brain tumor visualization in adults during surgery through fluorescence, enabling more complete removal of the tumor. This study aims to evaluate the feasibility of administering 5-ALA to pediatric brain tumor patients and to assess the quality of tumor fluorescence during surgery in this patient population.
For the clinical trial, the patient will orally ingest 5-ALA 6 to 12 hours before brain surgery. All study participants will be provided standard medical care for removal of the brain tumor. All children enrolled in the study will be closely monitored prior to, during, and after surgery to ensure there are no reactions to the study drug. 5-ALA can make the patient more sensitive to sunlight and direct indoor lighting, referred to as photosensitivity, and can cause a sunburn-type reaction. It is for this reason that patients will be kept in subdued light conditions for 48 hours following surgery. Study participation starts once the patient is enrolled in the study until 6-month post-surgery.

Start Date01 Dec 2025

Sponsor / Collaborator

University of Pittsburgh

[+4]

NCT07038278

/ Not yet recruitingEarly Phase 1IIT

5-AminoLevulinic Acid Aided Resection Margins in Sarcoma (5-ALARMS)

The goal of this study is to learn if the intervention using a fluorescent agent 5-Aminolevulinic acid (5-ALA) to aid in the surgical approach to visualize the soft-tissue sarcoma (STS) during surgical resection. 5-ALA goes through the blood stream and into the tumor tissue allowing it to light up when the surgeon uses a special light in the operating room. The technique is called 5-ALA fluorescence-guided surgery (FGS). The main question aims to answer if 5-ALA provide intraoperative fluorescent visualization of soft-tissue sarcoma versus surrounding tissue and demonstrate the efficacy of tumor and surgical margin resections by a gross and histological analysis of fluorescing and non-fluorescing samples immediately after removal. Participants will be asked to orally administer 5-ALA three to four hours prior to surgery in preoperative area.

Start Date01 Dec 2025

Sponsor / Collaborator

University of Colorado Denver

[+1]

NCT07201376

/ Not yet recruitingNot ApplicableIIT

Tissue Oxygen Imager

The primary objective of this study is the evaluation of the efficacy of the tissue oxygen imager based on PpIX DF in differentiating benign skin growth from non-melanoma skin cancer (NMSC).

Start Date01 Nov 2025

Sponsor / Collaborator

Dartmouth-Hitchcock Medical Center

[+1]

100 Clinical Results associated with Aminolevulinic Acid Hydrochloride

100 Translational Medicine associated with Aminolevulinic Acid Hydrochloride

100 Patents (Medical) associated with Aminolevulinic Acid Hydrochloride

7,874

Literatures (Medical) associated with Aminolevulinic Acid Hydrochloride

01 Mar 2026·Synthetic and Systems Biotechnology

Systems metabolic engineering of dual pathways with stage-specific activation for high-level 5-aminolevulinic acid production in Escherichia coli

Article

Author: Li, Changgeng ; Shi, Tang'en ; Liu, Yanghao ; Xu, Qingyang ; Yu, Zichen ; Zhao, Siyu ; Chen, Zhichao ; Miao, Yu ; Li, Lanxiao ; Ma, Ling

5-Aminolevulinic acid (5-ALA) is an important non-proteinogenic amino acid with wide applications in agriculture and medicine. To achieve high-level microbial production, this study established a dual-pathway reconstruction strategy in Escherichia coli by integrating the endogenous C5 pathway with an inducible exogenous C4 pathway. Multi-copy overexpression of gltX, hemA, and hemL, combined with enhanced glutamate supply and the introduction of a non-oxidative glycolysis pathway, effectively increased the C5 pathway flux and carbon efficiency, while product toxicity was significantly alleviated by strengthening efflux mechanisms and oxidative stress tolerance. A quorum sensing-based regulatory system was employed to dynamically regulate hemB expression, thereby balancing cell growth and 5-ALA biosynthesis, and a controlled glycine feeding strategy specifically activated the C4 pathway during the later fermentation stage, forming a stage-specific dynamic activation mechanism. Promoter regulation of sucC/sucD expression and enhanced endogenous PLP biosynthesis further stabilized the C4 flux. Fed-batch fermentation in a 5 L bioreactor resulted in a final 5-ALA titer of 37.34 g/L, demonstrating the industrial potential of this systems metabolic engineering strategy combining dual pathways and stage-specific activation control.

31 Dec 2025·JOURNAL OF DERMATOLOGICAL TREATMENT

Efficacy analysis of 5-aminolevulinic acid photodynamic therapy for vulvar lichen sclerosus in women of childbearing age

Article

Author: Zhu, Dongning ; Shi, Chunyu ; Jia, Yu ; Dang, Yanling ; Shang, Qian ; Yang, Lijuan

OBJECTIVE:

To investigate the efficacy and long-term durability of 5-aminolevulinic acid photodynamic therapy (ALA-PDT) in treating vulvar lichen sclerosus (VLS) in women of childbearing age.

METHODS:

Fifty-five patients with VLS who had failed long-term repeated pharmacological treatments (mean disease duration: 3.6 ± 1.4 years)were enrolled. All participants underwent four sessions of ALA-PDT. Follow-up evaluations were conducted for six months after treatment. Outcomes were assessed using the Cattaneo clinical symptom and sign score and the Dermatology Life Quality Index (DLQI) questionnaire at baseline, after four treatments, and at 3-6 months post-treatment.

RESULTS:

At the 6-month follow-up, efficacy rates were 81.8% for pruritus relief, 67.3% for skin elasticity restoration, 63.6% for skin color improvement, and 72.7% for lesion area reduction. Pain was the only reported adverse reaction during treatment.

CONCLUSION:

20% ALA-PDT is a safe, effective, and durable therapeutic option for VLS with minimal side effects. Notably, it provides a viable alternative for patients unresponsive to conventional therapies.

01 Dec 2025·JOURNAL OF NEURO-ONCOLOGY

Photodynamic therapy for glioblastoma: a narrative review

Review

Author: Huq, Sakibul ; Hadjipanayis, Constantinos ; Colan, Jhair ; Frederico, Stephen C ; Rentzeperis, Frederika ; Price, Gabrielle

PURPOSE:

Glioblastoma (GBM) remains one of the most aggressive primary brain tumors with poor survival outcomes and a lack of approved therapies. A promising novel approach for GBM is the application of photodynamic therapy (PDT), a localized, light-activated treatment using tumor-selective photosensitizers. This narrative review describes the mechanisms, delivery systems, photosensitizers, and available evidence regarding the potential of PDT as a novel therapeutic approach for GBM.

METHODS:

A comprehensive review of the preclinical and clinical literature was conducted on the role of PDT for GBM. Special emphasis was placed on PDT's mechanisms of action, immunomodulatory effects, delivery systems, and combinatorial potential with other treatment regimens. All clinical trials on this topic were reviewed and described.

RESULTS:

PDT exerts tumor-specific cytotoxic effects via reactive oxygen species generation, vascular disruption, and immune activation. Photosensitizers such as 5-aminolevulinic acid (5-ALA), chlorins, and phthalocyanines demonstrate selective accumulation in glioma cells and enhance treatment precision. Preclinical studies demonstrate that PDT can induce apoptosis, improve blood-brain barrier permeability, and synergize with existing chemotherapeutics. Early-phase clinical trials, including the INDYGO and talaporfin sodium-based studies, report promising safety profiles and extended survival in newly diagnosed and recurrent GBM patients.

CONCLUSION:

PDT offers a novel targeted approach for improving local control of GBM. With continued innovation in photosensitizer design, delivery technologies, and combinatorial strategies, PDT holds promise as a viable therapeutic adjunct in GBM treatment. Further clinical validation through randomized controlled trials is warranted to establish its efficacy and gain regulatory approval with the eventual goal of integration into standard neuro-oncology practice.

113

News (Medical) associated with Aminolevulinic Acid Hydrochloride

24 Oct 2025

·www.globenewswire.com

Biofrontera Inc. Closes Purchase of All Ameluz® and RhodoLED® US Assets from Biofrontera AG

Biofrontera Inc. acquires full U.S. rights to Ameluz® and RhodoLED®, including New Drug Application and associated patents, from former parent Biofrontera AG. New earnout structure reduces payment rate to 12%–15% of U.S. net sales from 25%–35%. Closing releases final $2.5 million of $11 million financing led by existing investors Rosalind Advisors and AIGH Capital Management, which is expected to fund Biofrontera Inc. to profitability. Oct. 23, 2025 -- Biofrontera Inc. (Nasdaq: BFRI) (“Biofrontera” or the “Company”), a biopharmaceutical company specializing in the development and commercialization of photodynamic therapy (PDT), today announced the closing of its restructuring and asset purchase agreement with its former parent company, Biofrontera AG. Under the transaction, Biofrontera Inc. has acquired all U.S. assets and rights related to Ameluz® and RhodoLED®, including the New Drug Application (NDA), Investigational New Drug Application (IND), manufacturing rights and contracts, all intellectual property, and related personnel. As a result of the transaction, Biofrontera Inc. will now pay a monthly earnout of 12% in years where annual U.S. net sales of Ameluz® are up to $65 million, and 15% in years where U.S. net sales are above that threshold. These payments will cease upon patent expiry. This replaces the prior transfer-pricing model under which the Company paid perpetual 25%–35% of net sales per tube, depending on timing and indication. The new structure reduces overall cost for Biofrontera Inc. and is expected to accelerate the Company’s timeframe to reach break-even. With the completion of this agreement, Biofrontera Inc. now assumes full responsibility for manufacturing, regulatory, quality management, pharmacovigilance, and commercialization of Ameluz® and the RhodoLED® portfolio in the U.S. The Company expects the full transfer of assets and personnel to be completed by late Q4 2025 or early Q1 2026. The transaction was funded through an $11 million investment led by existing investors Rosalind Advisors, Inc. and AIGH Capital Management LLC, $8.5 million of which was funded at the time of term-sheet execution. As part of the transaction, Biofrontera AG has received a 10% post-money equity stake in Biofrontera Inc., aligning long-term interests between the two entities. “This is a transformative transaction that strengthens Biofrontera’s financial and operational profile,” said Dr. Hermann Luebbert, Chief Executive Officer and Chairman of Biofrontera Inc. “The significantly reduced earnout structure is expected to drive meaningful gross margin expansion starting in the fourth quarter of 2025. Coupled with the new capital infusion, this positions us to accelerate Ameluz® growth and advance label expansion into additional indications.” Biofrontera Inc. is a U.S.-based biopharmaceutical company specializing in the development and treatment of dermatological conditions with a focus on PDT. The Company commercializes the drug-device combination Ameluz® with the RhodoLED® lamp series for PDT of Actinic Keratosis, pre-cancerous skin lesions which may progress to invasive skin cancers. The Company performs clinical trials to extend the use of the products to treat non-melanoma skin cancers and moderate to severe acne. The content above comes from the network. if any infringement, please contact us to modify.

License out/in

23 Sep 2025

·www.globenewswire.com

Biofrontera Inc. Engages Lytham Partners to Lead Strategic Investor Relations and Shareholder Communication Program

WOBURN, Mass., Sept. 23, 2025 (GLOBE NEWSWIRE) -- Biofrontera Inc. (Nasdaq: BFRI) (“Biofrontera” or the “Company”), a biopharmaceutical company specializing in the development and commercialization of photodynamic therapy (PDT), has engaged Lytham Partners to lead a strategic investor relations and shareholder communication program. For more than 20 years, Lytham Partners has been one of the country's leading investor relations firms, having created one of the industry's largest and most diverse networks of institutional investors, while creating a framework of best practices in all aspects of corporate and shareholder communications. In addition to their relationships with many of the industry's most respected institutional investors, Lytham Partners has spent the past two decades creating an integrated platform that allows its clients far reaching exposure to investors in a consistent and in-depth format. This platform is matched with a communications and positioning approach that is streamlined throughout press releases, conference calls, investor presentations, corporate profiles, and websites. Dr. Hermann Luebbert, Chief Executive Officer and Chairman of Biofrontera Inc., commented, “Through a series of transformative actions, including restructuring our relationship with our former parent company, acquiring U.S. intellectual property and new drug applications, taking control of manufacturing, and securing $11 million in new funding, we have positioned Biofrontera to achieve meaningful profitability in the quarters ahead. With our foundation strengthened and momentum building, we believe this is the ideal time to engage Lytham Partners to broaden our investor base and ensure our value proposition is fully recognized by the market.” “Biofrontera has made tremendous progress in recent months, establishing a strong foundation to become a leading U.S. specialty dermatology company. By advancing innovative therapies that meet the needs of dermatology professionals and their patients, the Company is focused on expanding its market presence, enhancing its competitive position, and creating meaningful long-term value for shareholders,” said Ben Shamsian, Vice President of Lytham Partners. “We look forward to introducing Biofrontera to our platform of investors, while supporting best practices within their communications program at all levels to keep shareholders apprised of the exciting developments taking place at the Company." To sign up for alerts on Biofrontera, please email or call Ben Shamsian at shamsian@lythampartners.com or 646-829-9701. About Biofrontera Inc. Biofrontera Inc. is a U.S.-based biopharmaceutical company specializing in the development and treatment of dermatological conditions with a focus on PDT. The Company commercializes the drug-device combination Ameluz® with the RhodoLED® lamp series for PDT of AK, pre-cancerous skin lesions which may progress to invasive skin cancers. The Company performs clinical trials to extend the use of the products to treat non-melanoma skin cancers and moderate to severe acne. For more information, visit www.biofrontera-us.com and follow Biofrontera on LinkedIn and X . Forward-Looking Statements Certain statements in this press release may constitute “forward-looking statements” within the meaning of the United States Private Securities Litigation Reform Act of 1995, as amended. These statements include, but are not limited to, statements relating to Biofrontera's commercial opportunities and the commercial success of its licensed products. We have based these forward-looking statements on our current expectations and projections about future events. Nevertheless, actual results or events could differ materially from the plans, intentions and expectations disclosed in, or implied by, the forward-looking statements we make. These risks and uncertainties, many of which are beyond our control, include, but are not limited to: the uncertainties inherent in the initiation and conduct of clinical trials; availability and timing of data from clinical trials; whether results of earlier clinical trials or trials of Ameluz® in combination with BF-RhodoLED and/or RhodoLED XL in different disease indications or product applications will be indicative of the results of ongoing or future trials; uncertainties associated with regulatory review of clinical trials and applications for marketing approvals; the impact of any extraordinary external events; any changes in the Company’s relationship with its licensors; the ability of the Company’s licensors to fulfill their obligations to the Company in a timely manner; the Company’s ability to achieve and sustain profitability; whether the current global disruptions in supply chains will impact the Company’s ability to obtain and distribute its licensed products; changes in the practices of healthcare providers, including any changes to the coverage, reimbursement and pricing for procedures using the Company’s licensed products; whether the market opportunity for Ameluz® in combination with BF- RhodoLED and/or RhodoLED XL is consistent with the Company’s expectations; the Company’s ability to retain and hire key personnel; the sufficiency of cash resources and need for additional financing; and other factors that may be disclosed in the Company’s filings with the Securities and Exchange Commission (the “SEC”), which can be obtained on the SEC’s website at www.sec.gov. Readers are cautioned not to place undue reliance on the forward-looking statements, which speak only as of the date on which they are made and reflect management’s current estimates, projections, expectations and beliefs. The Company does not plan to update any such forward-looking statements and expressly disclaims any duty to update the information contained in this press release except as required by law. Investor Relations Contact Ben ShamsianLytham Partners646-829-9701shamsian@lythampartners.com

16 Sep 2025

·www.globenewswire.com

Biofrontera Inc. Announces Last Patient Out in Phase 3 Study of Ameluz® (aminolevulinic acid HCI) Topical Gel, 10% Photodynamic Therapy (PDT) for the Treatment of Actinic Keratoses (AK) on the Extremities, Neck and Trunk

All 172 patients have now entered the 12-month follow-up phaseTrial involves larger surface areas, building on the approval in October 2024 for use of up to 3 tubes of Ameluz® per treatmentStudy results expected to form the basis of a supplemental New Drug Application (sNDA) planned for submission in Q2 2026 WOBURN, Mass., Sept. 16, 2025 (GLOBE NEWSWIRE) -- Biofrontera Inc. (Nasdaq: BFRI) (“Biofrontera” or the “Company”), a biopharmaceutical company specializing in the development and commercialization of photodynamic therapy (PDT), today announced that the final patient completed the active treatment phase of its Phase 3 clinical trial evaluating Ameluz® (10% 5-aminolevulinic acid hydrochloride gel) PDT for mild to moderate actinic keratoses (AKs) on the extremities, neck and trunk on September 3, 2025. All 172 enrolled patients have now entered the 12-month follow-up phase, expected to conclude in Q2 2026. Actinic keratosis is a common precancerous skin condition found on sun-exposed areas of the body: 58 million US adults have at least one AK lesion1. If left untreated these may progress to cutaneous squamous cell carcinomas, with more than 70% originating from AK lesions2. Expanding treatment options for AKs beyond the face and scalp would therefore address a critical unmet need in dermatology. This Phase 3 study is a multicenter, randomized, double-blind trial designed to evaluate the safety and efficacy of Ameluz® PDT versus vehicle gel in the treatment of actinic keratoses (AKs) on the extremities, neck and trunk. PDT was administered using a RhodoLED® or BF-RhodoLED® XL lamp following application of one to three tubes of either Ameluz® or vehicle to areas of approximately 80, 160 or 240 cm². Patients received a single PDT treatment, with a second one at 12 weeks if residual lesions remained. They are now being followed for 12 months to assess recurrence and new lesion development. In total, 172 subjects were enrolled in the study. “We are delighted to reach this stage in our clinical program,” said Dr. Hermann Luebbert, CEO and Chairman of Biofrontera Inc. “Building on the recent FDA approval for the use of up to 3 tubes of Ameluz® per treatment, today’s milestone marks another step in broadening the label and market potential for this product. Together, these developments reflect Biofrontera’s strategic progress toward leadership in PDT.” Dr. Nathalie Zeitouni, Mohs surgeon and clinical investigator at Medical Dermatology Specialists, Professor of Dermatology at the University of Arizona COM Phoenix and the coordinating investigator in the study, expressed enthusiasm about its’ potential impact. “We frequently see people with AKs on the trunk and extremities, and current treatment options are limited. Expanding the use of Ameluz® PDT to these areas would be a welcome advancement for dermatologists and our patients.” The 12-month follow-up phase is expected to be completed by Q2 2026. Pending positive outcomes, the company plans to submit a supplemental New Drug Application (sNDA) to the Food and Drug Administration (FDA) that same quarter. About Actinic Keratosis AK is the most common pre-cancerous skin lesion caused by chronic sun exposure that may, if left untreated, develop into life-threatening skin cancer called squamous cell carcinoma. AKs typically appear on sun-exposed areas such as the face, bald scalp, arms or the back of the hands. In 2020, approximately 58 million people in the US were affected by AK and 13 million AK treatments were performed.1 About Biofrontera Inc. Biofrontera Inc. is a U.S.-based biopharmaceutical company specializing in the treatment of dermatological conditions with a focus on PDT. The Company commercializes the drug-device combination Ameluz® with the RhodoLED® lamp series for PDT of AK, pre-cancerous skin lesions which may progress to invasive skin cancers. The Company performs clinical trials to extend the use of the products to treat non-melanoma skin cancers and moderate to severe acne. For more information, visit www.biofrontera-us.com and follow Biofrontera on LinkedIn and X. Forward-Looking Statements Certain statements in this press release may constitute “forward-looking statements” within the meaning of the United States Private Securities Litigation Reform Act of 1995, as amended. These statements include, but are not limited to, statements relating to Biofrontera's commercial opportunities and the commercial success of its licensed products. We have based these forward-looking statements on our current expectations and projections about future events. Nevertheless, actual results or events could differ materially from the plans, intentions and expectations disclosed in, or implied by, the forward-looking statements we make. These risks and uncertainties, many of which are beyond our control, include, but are not limited to: the impact of any extraordinary external events; any changes in the Company’s relationship with its licensors; the ability of the Company’s licensors to fulfill their obligations to the Company in a timely manner; the Company’s ability to achieve and sustain profitability; whether the current global disruptions in supply chains will impact the Company’s ability to obtain and distribute its licensed products; changes in the practices of healthcare providers, including any changes to the coverage, reimbursement and pricing for procedures using the Company’s licensed products; the uncertainties inherent in the initiation and conduct of clinical trials; availability and timing of data from clinical trials; whether results of earlier clinical trials or trials of Ameluz ® in combination with BF-RhodoLED and/or RhodoLED XL in different disease indications or product applications will be indicative of the results of ongoing or future trials; uncertainties associated with regulatory review of clinical trials and applications for marketing approvals; whether the market opportunity for Ameluz in combination with BF- RhodoLED and/or RhodoLED XL is consistent with the Company’s expectations; the Company’s ability to retain and hire key personnel; the sufficiency of cash resources and need for additional financing; and other factors that may be disclosed in the Company’s filings with the Securities and Exchange Commission (the “SEC”), which can be obtained on the SEC’s website at www.sec.gov. Readers are cautioned not to place undue reliance on the forward-looking statements, which speak only as of the date on which they are made and reflect management’s current estimates, projections, expectations and beliefs. The Company does not plan to update any such forward-looking statements and expressly disclaims any duty to update the information contained in this press release except as required by law. Contact:Investor RelationsBen Shamsian, Lytham Partners +1-646-829-9701ir@bfri.com References1. Skin Cancer Foundation Actinic Keratosis Overview. https://www.skincancer.org/skin-cancer-information/actinic-keratosis/#:~:text=Actinic%20keratosis%20(AK)%20is%20the,to%20ultraviolet%20(UV)%20radiation2. Thomson et al, Br J Derm, 189 (1): July 2023; e4–e5

Phase 3Clinical Result

100 Deals associated with Aminolevulinic Acid Hydrochloride

External Link

KEGG	Wiki	ATC	Drug Bank
D02908	Aminolevulinic Acid Hydrochloride	L01XD04	DB00855

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
Carcinoma of urinary bladder, invasive	Japan	SBI Pharmaceuticals Co., Ltd.	27 Sep 2017
Glioblastoma Multiforme	Australia	Specialised Therapeutics Glio Pty Ltd	07 Nov 2013
Contrast agents	Japan	Nobelpharma Co., Ltd.	25 Mar 2013
Basal Cell Carcinoma	European Union	Biofrontera Bioscience GmbH	13 Dec 2011
Basal Cell Carcinoma	Iceland	Biofrontera Bioscience GmbH	13 Dec 2011
Basal Cell Carcinoma	Liechtenstein	Biofrontera Bioscience GmbH	13 Dec 2011
Basal Cell Carcinoma	Norway	Biofrontera Bioscience GmbH	13 Dec 2011
Glioma	European Union	Photonamic GmbH & Co. KG	07 Sep 2007
Glioma	Iceland	Photonamic GmbH & Co. KG	07 Sep 2007
Glioma	Liechtenstein	Photonamic GmbH & Co. KG	07 Sep 2007
Glioma	Norway	Photonamic GmbH & Co. KG	07 Sep 2007
Condylomata Acuminata	China	Shanghai Fudan Zhangjiang Bio Pharmaceutical Co., Ltd.	14 Feb 2007
Actinic Keratosis	United States	Sun Pharmaceutical Industries, Inc.	03 Dec 1999

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Non-Muscle Invasive Bladder Neoplasms	Phase 3	China	Shanghai Fudan Zhangjiang Bio Pharmaceutical Co., Ltd.	11 Mar 2025
Ovarian Epithelial Carcinoma	Phase 3	United States	NX Development Corp.	30 May 2024
Recurrent ovarian cancer	Phase 3	United States	NX Development Corp.	30 May 2024
Adenoid Cystic Carcinoma	Phase 3	United States	Sbi Alapharma Canada, Inc.	27 Apr 2021
Breast Cancer	Phase 3	United States	Sbi Alapharma Canada, Inc.	27 Apr 2021
Breast Ductal Carcinoma	Phase 3	United States	Sbi Alapharma Canada, Inc.	27 Apr 2021
Carcinoma	Phase 3	United States	Sbi Alapharma Canada, Inc.	27 Apr 2021
Ductal Carcinoma	Phase 3	United States	Sbi Alapharma Canada, Inc.	27 Apr 2021
Invasive Lobular Breast Carcinoma	Phase 3	United States	Sbi Alapharma Canada, Inc.	27 Apr 2021
Mucinous breast cancer	Phase 3	United States	Sbi Alapharma Canada, Inc.	27 Apr 2021

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT06027619 (CTgov)	Phase 2	Pain \| Actinic Keratosis	30	Red light illumination+Topical aminolevulinate (10% ALA gel) (Regimen A)	qncfnhitie = yxnbtxbrra liudhqwgzj (ndhtlzhqgf, oqzhvhcvem - npmealeion) View more	-	23 Oct 2025
				Red light illumination+Topical aminolevulinate (10% ALA gel) (Regimen B)	qncfnhitie = eswskitena liudhqwgzj (ndhtlzhqgf, tljylnnspq - dsppdeemyd) View more
NCT04815083 (CTgov)	Phase 3	Breast Ductal Carcinoma \| Ductal Carcinoma \| Invasive Lobular Breast Carcinoma ... View more	57	PD G 506 A	wrvbidoczn(ivetcbzurx) = qalnsgybao ndvvirwicc (aruoklfuqt, nirvhdurvi - ddxvxxaaqk) View more	-	03 Sep 2025
NCT05101798 (CTgov)	Phase 2	Skull Base Neoplasms \| Head and Neck Neoplasms	7	5-Aminolevulinic acid Hydrochloride	avfzvqpdhc = xtsiyacnza dwtvnodtei (ydpyfmeqlr, uvsesogjty - ihteixcwiv) View more	-	28 Jul 2025
NCT03573401 (ALA-BCC-CT013, CTgov)	Phase 3	Superficial basal cell carcinoma	187	ALA (BF-200 ALA)	zoiucpetaa = hgxjuwnsum kasxjxglsq (whiabjqnye, iixosbwmfv - fazeznfeib) View more	-	29 Apr 2025
				Placebo Photodynamic therapy (PDT) (vehicle to BF-200 ALA containing no active ingredient) (Vehicle)	zoiucpetaa = pjtxadxzwp kasxjxglsq (whiabjqnye, onisuqrkql - yrvapwfmbx) View more
NCT01128218 (Phase 2 Sensitivity and Selectivity Study, Pubmed \| Oper Neurosurg (Hagerstown))	Phase 2	Recurrent Glioblastoma	31	High-dose 5-ALA (>40 mg/kg)	mrocxiowfw(xhugpaiuxf) = cluhkxefpq zwmujxueoc (lkyrikqhzd ) View more	Positive	11 Nov 2024
				Low/standard dose 5-ALA (<30 mg/kg)	mrocxiowfw(xhugpaiuxf) = xxmpzykzas zwmujxueoc (lkyrikqhzd ) View more
TMOD-04 (SNO2024)	Phase 1	-	8	Sonodynamic Therapy with 5-ALA HCL Oral Solution and CV-01	wrugfkgeak(jhecneibtw) = nzzmhpsaez qzegkqejwt (txhcyrzqea )	Positive	11 Nov 2024
				5-ALA HCL oral solution (Control Group)	wrugfkgeak(jhecneibtw) = gkwqyqkacg qzegkqejwt (txhcyrzqea )
NCT03573401 (ALA-BCC-CT013, GlobeNewswire) Manual	Phase 3	Basal Cell Carcinoma	187	Ameluz®-PDT	igrkzmjgob(klcomlqtzj) = gtctorxckd rgwjnfbbgq (mqcakbdrop ) View more	Positive	31 Oct 2024
				Placebo-PDT	igrkzmjgob(klcomlqtzj) = plyomfaxlc rgwjnfbbgq (mqcakbdrop ) View more
P18.53.A (EANO2024)	Not Applicable	Glioblastoma Adjuvant 5-aminolevulinic acid (5-ALA) positive	23	5-aminolevulinic acid (5-ALA) (No residual 5-ALA)	nncglvddam(fjaarvbgnl) = eoczpwsuuo lltlwxpgdu (dfltlmwqav ) View more	Negative	17 Oct 2024
				5-aminolevulinic acid (5-ALA) (Focal residual 5-ALA)	nncglvddam(fjaarvbgnl) = smrxweslym lltlwxpgdu (dfltlmwqav ) View more
NCT05060237 (CTgov)	Phase 1	Actinic Keratosis	112	5-ALA (5-aminolevulinic acid)	vqhrcyzikx = ooyoszkzqe nyemvtqjxu (xqpnncmczj, euylsqureg - owijqvrdys) View more	-	17 Oct 2024
NCT03048240 (INDYGO, Pubmed \| J Neurooncol)	Not Applicable	Glioblastoma 5-aminolevulinic acid hydrochloride (5-ALA HCl)	-	Intraoperative photodynamic therapy (PDT) with 5-aminolevulinic acid hydrochloride (5-ALA HCl)	xerxaaczkx(yllohsurkm) = dgdeojnyyf eifvooxwxg (nucbgcjxxd ) View more	Positive	01 Jul 2024

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