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Last update 09 May 2025

Aminolevulinic Acid Hydrochloride

Last update 09 May 2025

Overview

R&D Status

Clinical Result

Translational Medicine

Overview

Basic Info

Drug Type

Small molecule drug

Synonyms

5-ALA HCl, 5-aminolevulinic acid (ALA), 5-aminolevulinic acid hydrochloride

+ [28]

Target-

Action-

Mechanism

Photosensitizers

Therapeutic Areas

NeoplasmsInfectious DiseasesNervous System Diseases+ [6]

Active Indication

Carcinoma of urinary bladder, invasiveGlioblastoma MultiformeContrast agents+ [31]

Inactive Indication

Basal Cell Nevus SyndromeNon-Cutaneous MelanomaOnychomycosis+ [4]

Originator Organization

DUSA Pharmaceuticals, Inc.

Active Organization

Tohoku UniversityPhotonamic GmbH & Co. KG

NX Development Corp.

+ [14]

Inactive Organization

medac Gesellschaft für klinische Spezialpräparate mbH

DUSA Pharmaceuticals, Inc.

License Organization

+ [6]

Drug Highest PhaseApproved

First Approval Date

United States (03 Dec 1999),

Actinic Keratosis

RegulationFast Track (United States), Orphan Drug (United States), Orphan Drug (Japan), Orphan Drug (South Korea)

Structure/Sequence

Molecular FormulaC5H10ClNO3

InChIKeyZLHFONARZHCSET-UHFFFAOYSA-N

CAS Registry5451-09-2

Sequence Code 178207

307

Clinical Trials associated with Aminolevulinic Acid Hydrochloride

NCT06777511

/ Not yet recruitingNot ApplicableIIT

Advancing Antimicrobial Photodynamic Therapy to Prevent Infection in Osseointegrated Prosthesis Patients

This will be a prospective observational trial enrolling 20 patients with osseointegrated prostheses. Participants will be recruited from the orthopaedic outpatient clinic at Walter Reed National Military Medical Center in Bethesda, MD.
All eligible consenting patients will undergo daily stoma management per standard of care.
Patients will integrate antimicrobial photodynamic therapy into their stoma management program. The first treatment will take place in the orthopaedic clinic. All others will take place at home. Topical 5-ALA will be applied to the metal at the penetration site. After 2 hours, the light delivery device will be utilized and light will be administered for 15 minutes.
Data collection: After obtaining informed consent, study personnel will record injury-specific variables, surgery-specific variables, other variables related to their hospital course, demographic variables as well as comorbidities on the study case report forms (CRFs). They will obtain this information directly from the participant, from the participant's medical record, and the participant's treating orthopaedic surgeon or other health care providers. Baseline data collection points include participant characteristics and amputation details such as age, sex, comorbidities, highest education level achieved, social support, initial reason for amputation, type of amputation and all surgical dates. Study participants will be followed at 1 and 2 weeks after initiation of PDT treatment. To ensure research participant safety, serious adverse events (SAEs) will be documented and promptly submitted to the local IRB as per the required reporting processes.
Follow-up: Study participants will be followed at 1 week and 2 weeks.

Start Date01 Aug 2025

Sponsor / Collaborator

Dartmouth-Hitchcock Medical Center

[+1]

NCT06907485

/ Not yet recruitingPhase 2IIT

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 Jun 2025

Sponsor / Collaborator

University of Pittsburgh

[+4]

NCT06876038

/ Not yet recruitingPhase 2IIT

A Comprehensive Platform for Low-cost Screening and Image-guided Photodynamic Therapy (PDT) Treatment of Pre-malignant and Malignant Oral Lesions in Low-resource Setting

The primary goal of this study is to see if photodynamic therapy (PDT) is effective for treatment of lesions in the oral cavity which have high risk of becoming oral cancer. PDT treatment uses a drug, called a photosensitizer, which makes the diseased cells become light-sensitive such that they are destroyed when laser light is delivered to the target lesion. In this study a new handheld device, called SITOS (a "Screen, Image and Treat Optical System), is used. The ability of this device to simultaneously visualize the inside of the mouth and deliver laser light to the target site will be evaluated. The main questions this study seeks to answer are:
* Can this treatment completely cure oral potentially malignant lesions (OPML) without need for surgery?
* Do lesions recur after PDT treatment?
* Is the SITOS device easy to use for the doctor and comfortable for the patient, both as an oral imaging device and as a treatment device?

Start Date01 May 2025

Sponsor / Collaborator

University of Massachusetts Boston

[+4]

100 Clinical Results associated with Aminolevulinic Acid Hydrochloride

100 Translational Medicine associated with Aminolevulinic Acid Hydrochloride

100 Patents (Medical) associated with Aminolevulinic Acid Hydrochloride

10,252

Literatures (Medical) associated with Aminolevulinic Acid Hydrochloride

01 Dec 2025·CHILDS NERVOUS SYSTEM

5-Aminolevulinic acid (5-ALA) in paediatric brain tumour surgery—a systematic review and exploration of fluorophore alternatives

Review

Author: Kanodia, Charvi ; Kaliaperumal, Chandrasekaran ; Yahya, Qalisya Binti ; Liistro, Marianna ; Collins, Victoria G

PURPOSE:

Paediatric brain tumours represent the most common solid malignancies in children, with extent of resection being a critical prognostic factor. Fluorescence-guided surgery using 5-aminolevulinic acid (5-ALA) is well-established for adult high-grade gliomas, but its efficacy and safety in paediatric populations remain unclear. This systematic review evaluates the utility of 5-ALA fluorescence-guided surgery in paediatric brain tumours and explores alternative fluorophores.

METHODS:

A systematic review was conducted according to PRISMA guidelines, analysing studies from MEDLINE and EMBASE published up to October 2024. Data on patient demographics, tumour fluorescence patterns, surgical outcomes, and adverse effects were extracted. Statistical analyses assessed fluorescence differences across tumour types and administration parameters.

RESULTS:

Twenty-three studies, including 281 paediatric patients (mean age, 10 years), were analysed. The most common tumours included pilocytic astrocytomas (n = 45), medulloblastomas (n = 45), glioblastomas (n = 35), and ependymomas (n = 27). Strong fluorescence was observed more frequently in high-grade gliomas compared to low-grade gliomas (p < 0.00001), non-glioma tumours (p < 0.00001), and high-grade non-glioma tumours (p = 0.000485). Adverse effects were mostly transient; rare complications included transaminitis and dermatologic reactions.

CONCLUSION:

5-ALA fluorescence-guided surgery shows promise in the resection of high-grade gliomas in paediatric patients, improving intraoperative visualisation. However, limited fluorescence in low-grade and non-glioma tumours underscores the need for tumour-specific approaches. Emerging alternatives, such as fluorescein sodium and tozuleristide, offer potential advantages. Future research should focus on optimising 5-ALA dosing, refining timing protocols, and conducting robust prospective trials to establish efficacy and safety in paediatric populations.

01 Aug 2025·BIORESOURCE TECHNOLOGY

Light/dark cycles and iron supplementation to enhance the simultaneous production of polyhydroxyalkanoates, 5-aminolevulinic acid, coenzyme Q10, and pigments through photofermentation

Article

Author: Montiel-Corona, Virginia ; Buitrón, Germán

This study aimed to obtain 5-aminolevulinic acid (5-ALA), Coenzyme Q₁₀ (CoQ₁₀), polyhydroxyalkanoates (PHA), carotenoids, and bacteriochlorophylls (Bchl) through the photofermentation of residual wine lees. Light/dark cycles and iron supplementation were evaluated. Under 12-hour light/dark cycles, the production of 5-ALA, CoQ₁₀, carotenoids, and Bchl increased by 1.7, 2.8, 1.7, and 2.4 times, respectively, compared to the continuous illumination control, while PHA production decreased from 511 to 445 mg/L. Combining light/dark cycles with iron supplementation enhanced the biomass production rate. The CoQ₁₀ content increased by 4.9 times (reaching 8.8 mg/g-dw), carotenoids by 3.7 times (6.4 mg/g-dw), and Bchl by 6.4 times (17.9 mg/g-dw) compared to the control treatment, while maintaining 5-ALA at 5.3 µmol/L and PHA at 377 mg/L. The combination of light/dark cycles and iron provides a triple benefit: increased production of value-added substances, enhanced biomass production rate, and improved organic matter removal, making it an attractive option for winery effluent treatment and valorization.

01 Jul 2025·JOURNAL OF COLLOID AND INTERFACE SCIENCE

H2O2/O2 Self-Supplied Nanoplateform for amplifying oxidative stress to Accelerate Photodynamic/Chemodynamic therapy Cycles

Article

Author: Li, Yong ; Lv, Longhao ; Xi, Jianying ; Liu, Fangfang ; Liu, Jinliang ; Tang, Zhengshuai

Photodynamic (PDT) and chemodynamic therapies (CDT) relying on reactive oxygen species-mediated treatments mainly face various challenges of hypoxia, endogenous hydrogen peroxide (H₂O₂) deficiency, and glutathione (GSH) overexpression in the tumor microenvironment. Herein, we propose a novel strategy using a core-shell structured nanocomposite, UCNP@mSiO₂@5-ALA-CaO₂-Cu(UA@CC). The strategy centers on upconverting NPs and then utilizes mesoporous silica loaded with 5-aminolevulinic acid (5-ALA) to maximize the enrichment of protoporphyrin IX (Pph IX), an intra-tumor photosensitizer. Then in the acidic tumor microenvironment (TME), CaO₂ in the outer layer reacts with H₂O to form O₂, H₂O₂ and Ca²⁺, and the released H₂O₂ serves as an auxiliary "fuel" to induce acceleration of the Fenton-like (Cu²⁺) reaction and inactivation of the antioxidant GSH enzyme, thus enhancing the tumor cells' Catalysis. Furthermore, under the excitation of a 980 nm laser, 5-ALA-mediated PDT and Cu⁺-based CDT were initiated. Through interconnected processes of Ca²⁺ overload, self-supply of H₂O₂/O₂, and enhanced GSH depletion, an accelerated cycling strategy for combined PDT/CDT therapy was established, resulting in amplified oxidative stress and anti-tumor capabilities, which was validated in cancer cells and melanoma mouse models.

News (Medical) associated with Aminolevulinic Acid Hydrochloride

18 Mar 2025

·www.globenewswire.com

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

First US Phase 3 study of Photodynamic Therapy (PDT) to include neck, trunk and extremitiesProtocol involves one or two PDT treatments using 1-3 tubes of Ameluz® or vehicle gel over a surface area of up to 240 cm2Treatment phase expected to be complete by Q3 2025 WOBURN, Mass., March 18, 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 the enrollment of the final patient in its Phase 3 clinical trial evaluating Ameluz® (aminolevulinic acid hydrochloride) for the treatment of mild to moderate actinic keratoses (AKs) on the extremities, neck and trunk. Actinic keratosis is a common skin condition found on sun-exposed areas of the body, and if left untreated, may progress to squamous cell carcinoma. Expanding field treatment options for AKs beyond the face and scalp would address a critical unmet need in dermatology. This trial is a multicenter, randomized, double-blind study comparing Ameluz® with vehicle in the field-directed treatment of actinic keratoses (AK) located on the extremities, neck and trunk with PDT using a RhodoLED lamp (BF-RhodoLED® XL or BF-RhodoLED®). It is designed to assess the safety and efficacy of Ameluz® PDT following the application of 1-3 tubes of product over a surface area (continuous or in patches) of approximately 80, 160 or 240cm2. Patients receive one PDT treatment with either Ameluz® or vehicle gel, and a second one at 12 weeks if at least one AK lesion remains. They are then followed up for approximately one year after the last PDT treatment. The study enrolled 172 patients who received either Ameluz® or vehicle gel in a ratio of 4:1. “We are thrilled to reach this pivotal stage in our clinical program,” said Dr. Hermann Luebbert, CEO and Chairman of Biofrontera Inc. “The successful enrollment of our last patient brings us one step closer to potentially offering an effective treatment option for patients with actinic keratoses on the extremities, neck and trunk. It marks a significant step in expanding the indications for Ameluz® and further demonstrates our commitment to the development of PDT.” Dr. Nathalie Zeitouni, Mohs surgeon and principal investigator at Medical Dermatology Specialists, Professor of Dermatology at the University of Arizona COM Phoenix, discussed the potential impact of the study. “Ameluz® PDT has already proven to be a valuable option for the treatment of AKs on the face and scalp. We see many patients who have these lesions on other areas of the body, and the possibility of expanding the use of Ameluz® to treat those areas is promising for both physicians and for our patients. I look forward to seeing the results of this study." With enrollment complete, Biofrontera anticipates finishing the treatment phase of the study by September, 2025 and the follow-up phase by Q2 2026. Pending positive outcomes, the company plans to submit a supplemental New Drug Application (sNDA) to the Food and Drug Administration (FDA) in the second half of 2026. 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.3 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 the clinical development strategy for Ameluz®, ongoing clinical trials and the future impact of such trials on the market for Ameluz®, 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 RelationsAndrew Barwicki1-516-662-9461ir@bfri.com

Phase 3Clinical Result

25 Feb 2025

·www.prnewswire.com

Alpheus Medical Publishes Promising Early Clinical Results of Sonodynamic Therapy for the Treatment of Newly Diagnosed Glioblastomas

CHANHASSEN, Minn., Feb. 25, 2025 /PRNewswire/ -- Alpheus Medical, Inc., a private, clinical-stage oncology company pioneering sonodynamic therapy (SDT) for the treatment of solid body cancers, today announced the publication of a study in the Journal of Neuro-Oncology showcasing its proprietary SDT treatment in three patients with newly diagnosed glioblastomas that were not candidates for gross total tumor resection. The study reported no adverse effects with an immediate positive imaging and histopathological response indicating cancer cell death, with no impact on healthy brain tissue, after a single dose of SDT. The Company shared that it expects to begin a randomized control trial in patients with newly diagnosed glioblastoma later this year. Continue Reading "The early clinical results are very encouraging for advancing treatment options in patients with newly diagnosed glioblastoma, a disease with few effective therapies," commented Walter Stummer, Professor and Director of the Department of Neurosurgery of the University Hospital Münster, Germany, and the senior author of the study. "Sonodynamic therapy's ability to selectively induce immediate tumor cell death while sparing healthy brain tissue is unprecedented. Additionally, its diffuse nature allows treatment across the entire hemisphere, including the peripheral invasive zone and beyond, a major challenge in neuro-oncology. These factors suggest that SDT could be a significant breakthrough in glioblastoma treatment." "SDT's ability to selectively induce immediate tumor cell death while sparing healthy brain tissue is unprecedented." Post this Alpheus Medical's novel SDT therapy delivers low-intensity diffuse ultrasound (LIDU™) combined with oral 5-aminolevulinic acid (5-ALA) to selectively target and destroy cancer cells across the entire brain hemisphere. This non-invasive treatment, performed without the need for imaging or sedation, offers a revolutionary new approach to cancer care in an outpatient setting. This news builds on the previously presented first-in-human positive results from the Company's Phase 1/2 trial in recurrent, high-grade glioma patients, a population with very short survival expectancy. The open-label, multicenter study demonstrated a greater than twofold increase in median overall survival and a threefold improvement in progression-free survival for patients treated with SDT, underscoring its potential as a transformative therapy for this aggressive disease. About Alpheus Medical, Inc. Alpheus Medical is a private, clinical-stage oncology company revolutionizing the treatment of solid body cancers with its pioneering sonodynamic therapy (SDT) platform that combines Low-Intensity Diffuse Ultrasound (LIDUTM) with the sensitizing agent, oral 5-aminolevulinic acid (5-ALA). The company's proprietary, non-invasive technology is designed to selectively target and destroy cancer cells in the brain while preserving healthy tissue. Alpheus Medical collaborates with global neuro-oncology leaders and receives support from Brightedge, the impact investment and innovation arm of the American Cancer Society, and the Brain Tumor Investment Fund, a subsidiary of the National Brain Tumor Society. Learn more at . SOURCE Alpheus Medical WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Clinical ResultASCO

08 Jan 2025

·www.globenewswire.com

Biofrontera Inc. Announces Achievement of Key Milestone In Phase 3 Study Of Ameluz®-Photodynamic Therapy (PDT) In The Treatment Of Superficial Basal Cell Carcinoma (sBCC)

Last patient completed 1 year follow-up of study ALA-BCC-CT013 in December 2024.Data from follow-up will be included in FDA submission, expected in Q3 2025.Biofrontera announced highly statistically significant results for all primary and secondary endpoints (p <0.0001) in October 2024.BCC, of which sBCC is a subgroup, is the most common skin cancer in the US with more than 3 million cases each year1. WOBURN, Mass., Jan. 08, 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 a key milestone in its Phase 3 study of the use of Ameluz and RhodoLED PDT in the treatment of sBCC (ALA-BCC-CT013) was met with the last patient completing the 1 year follow-up visit in December of 2024. The double-blind, randomized, placebo-controlled, multi-center study evaluated safety and efficacy in 187 patients with one or more clinically and histologically confirmed superficial BCCs. They each received one cycle of two PDT treatments (either Ameluz® -PDT or placebo-PDT) 1-2 weeks apart. Lesions that were not completely resolved after 3 months were retreated. The FDA has advised Biofrontera to submit the sNDA with one-year follow-up data. While 1-year data will support the FDA submission, the superficial BCC lesions will in total be followed up for five years. Long-term follow-up studies are often required by the FDA for dermatology product submissions, in particular for skin cancers, and they are important in trials enrolling sBCC patients due to the risk of local recurrence, or subsequent additional skin cancer development. “We were delighted with the highly statistically significant results for the primary and secondary endpoints that we communicated last year”, stated Dr Hermann Luebbert, CEO and Chairman of Biofrontera Inc. “The completion of the 1-year follow-up is a crucial milestone in our path to an FDA submission in 2025 and potentially expanding our label to the treatment of a cutaneous malignancy. It demonstrates our continued investment in PDT and supports our vision of partnering with the dermatology community to improve patient care” he concluded. “We routinely use PDT in our institution for the treatment of actinic keratoses” commented Dr Shane Chapman, Chair of the Department of Dermatology at Dartmouth Hitchcock Medical Center and the Geisel School of Medicine at Dartmouth, and an investigator for ALA-BCC-CT013. “We were impressed with the results of the 12-week data and I look forward to being able to offer Ameluz-PDT as a treatment option for my patients with sBCC”. About Basal Cell Carcinoma BCC is the most common form of skin cancer and the most frequently occurring form of all cancers. In the U.S. alone, an estimated 3.6 million cases are diagnosed each year, a subset of which is superficial basal cell carcinoma. BCCs arise from abnormal, uncontrolled growth of basal cells at the bottom of the epidermis. They rarely spread beyond the original tumor site but, if untreated, can become locally invasive, grow wide and deep into the skin, and destroy skin, tissue and bone. 1 https://www.skincancer.org/skin-cancer-information/basal-cell-carcinoma/ 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 Twitter. 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 the clinical development strategy for Ameluz®, ongoing clinical trials and the future impact of such trials on the market for Ameluz®, 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 RelationsAndrew Barwicki1-516-662-9461ir@bfri.com

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
Breast Cancer	Phase 3	United States	Sbi Alapharma Canada, Inc.	27 Apr 2021
Carcinoma	Phase 3	United States	Sbi Alapharma Canada, Inc.	27 Apr 2021
Meningioma	Phase 3	United States	NX Development Corp.	28 Oct 2020
Meningioma	Phase 3	Austria	NX Development Corp.	28 Oct 2020
Meningioma	Phase 3	Germany	NX Development Corp.	28 Oct 2020
Superficial basal cell carcinoma	Phase 3	United States	Biofrontera Bioscience GmbH	25 Sep 2018
Malignant glioma of brain	Phase 3	Japan	Nobelpharma Co., Ltd.	01 Aug 2010

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03573401 (ALA-BCC-CT013, CTgov)	Phase 3	Superficial basal cell carcinoma	187	ALA (BF-200 ALA)	vubfawluzr = zyqdkibhhs weqizfwhhb (iubauzfpim, haotblcwtb - ranensuhyw) View more	-	29 Apr 2025
				Placebo Photodynamic therapy (PDT) (vehicle to BF-200 ALA containing no active ingredient) (Vehicle)	vubfawluzr = ftmeovszww weqizfwhhb (iubauzfpim, bxvlklxbmn - hzzkppgbce) 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)	bwrhgapwcq(rtinzpxxzv) = pdarwudzfi toxucgdgmm (altxmofxeu ) View more	Positive	11 Nov 2024
				Low/standard dose 5-ALA (<30 mg/kg)	bwrhgapwcq(rtinzpxxzv) = fzbqjvttoh toxucgdgmm (altxmofxeu ) View more
TMOD-04 (SNO2024)	Phase 1	-	8	Sonodynamic Therapy with 5-ALA HCL Oral Solution and CV-01	xdqvmfykfr(ovqxjjqikc) = zfwnmubxxj imkrzgwcou (fbqdyehnwy )	Positive	11 Nov 2024
				5-ALA HCL oral solution (Control Group)	xdqvmfykfr(ovqxjjqikc) = hrwhggpadw imkrzgwcou (fbqdyehnwy )
NCT03573401 (ALA-BCC-CT013, GlobeNewswire) Manual	Phase 3	Basal Cell Carcinoma	187	Ameluz®-PDT	ismlvzumwk(mvtzvjinmg) = jabjjajziv bahoroyrmd (ftqldvggdt ) View more	Positive	31 Oct 2024
				Placebo-PDT	ismlvzumwk(mvtzvjinmg) = aazofqxqgg bahoroyrmd (ftqldvggdt ) View more
P10.22.B (EANO2024)	Not Applicable	Glioma	163	5-ALA (Fluorescent Gliomas)	ddhwrruxrm(tpvyrriltu) = nmlezfmthz mrjvnaavak (rmiabzjped ) View more	Positive	17 Oct 2024
P18.53.A (EANO2024)	Not Applicable	Glioblastoma Adjuvant 5-aminolevulinic acid (5-ALA) positive	23	5-aminolevulinic acid (5-ALA) (No residual 5-ALA)	bpgyhvqhio(iiavgvbtnu) = wicpznntyd zanrszlhxf (rwubdfwkbr ) View more	Negative	17 Oct 2024
				5-aminolevulinic acid (5-ALA) (Focal residual 5-ALA)	bpgyhvqhio(iiavgvbtnu) = jvrtspzeug zanrszlhxf (rwubdfwkbr ) View more
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)	ztdblhqxja(ebrxgxjgpn) = snbaydgpmw stqxzthpml (odmdcbyctf ) View more	Positive	01 Jul 2024
NCT03327831 (CTgov)	Phase 4	Actinic Keratosis	30	Aminolevulinic Acid	ydkdmgrotf(golrtsxrnv) = auxugbcygo aegmbzqoyg (cihawwihsj, jmmnqihguc - eiqbnwhers) View more	-	27 Jun 2024
MP77-20 (AUA2024)	Not Applicable	Non-Muscle Invasive Bladder Neoplasms	33	Fluorescence cystoscopy using oral 5-aminolevulinic acid (ALA)	nexpxenerf(pejrypknuj) = rwoueguegt neujuejeoj (icrmwohwmu ) View more	Positive	01 May 2024
				5-aminolevulinic acid (White-light endoscopy)	nexpxenerf(pejrypknuj) = fkpvxguhnu neujuejeoj (icrmwohwmu ) View more

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