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Last update 07 Feb 2025

Aminolevulinic Acid Hydrochloride

Last update 07 Feb 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-

Mechanism

Photosensitizers

Therapeutic Areas

NeoplasmsInfectious DiseasesNervous System Diseases+ [5]

Active Indication

Carcinoma of urinary bladder, invasiveGlioblastoma MultiformeContrast agents+ [24]

Inactive Indication

Non-Cutaneous MelanomaOnychomycosisRecurrent Malignant Glioma+ [3]

Originator Organization

DUSA Pharmaceuticals, Inc.

Active Organization

SBI Pharmaceuticals Co., Ltd.

NX Development Corp.

Shanghai Fudan Zhangjiang Bio Pharmaceutical Co., Ltd.

+ [15]

Inactive Organization

medac Gesellschaft für klinische Spezialpräparate mbH

Medac SrL

Drug Highest PhaseApproved

First Approval Date

US (03 Dec 1999),

Actinic Keratosis

RegulationFast Track (US), Orphan Drug (US), Orphan Drug (KR), Orphan Drug (JP)

Structure/Sequence

Molecular FormulaC5H10ClNO3

InChIKeyZLHFONARZHCSET-UHFFFAOYSA-N

CAS Registry5451-09-2

Sequence Code 178207

310

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 Mar 2025

Sponsor / Collaborator

Dartmouth-Hitchcock Medical Center

[+1]

NCT06623201

/ Not yet recruitingPhase 1IIT

Blue-Light Photodynamic Therapy and Sonidegib for Multiple Basal Cell Carcinomas

This research study is testing combination Blue-light photodynamic therapy and Sonidegib as a possible treatment for people with multiple basal cell carcinoma lesions.
Basal cell carcinoma lesions are typically treated by freezing the lesion or surgically removing the lesion. These types of treatment can cause scarring. Photodynamic therapy uses light along with a drug applied to the skin to kill the cancer cells and cause them to break apart. The light used can cause the skin to feel warm, but does not cause scarring.

Start Date01 Dec 2024

Sponsor / Collaborator-

NCT06678867

/ Not yet recruitingPhase 2IIT

A Phase II Multicentre Trial for the Use of 5-ALA Paediatric Patients with High Grade Brain Tumours

The aim of the study is to examine the safety and feasibility of using 5-ALA in children who have MRI scans showing an aggressive looking brain tumour. It will also study if 5-ALA can help the surgeon achieve maximal tumour removal and discriminate between normal brain tissue and tumour.
Patients will be between 3-18 years (inclusive) and all patients will receive 5-ALA 3-6 hours prior to resection surgery.

Start Date30 Nov 2024

Sponsor / Collaborator

University College London

[+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

10,884

Literatures (Medical) associated with Aminolevulinic Acid Hydrochloride

01 Apr 2025·MAGNETIC RESONANCE IN MEDICINE

Imaging treatment efficacy of repeated photodynamic therapy in glioblastoma using chemical exchange transfer saturation MRI

Article

Author: Liu, Yang ; Lai, Joseph H. C. ; Chen, Zilin ; Leung, Vivian W. M. ; Huang, Jianpan ; Chan, Kannie W. Y. ; Park, Se Weon ; Hu, Charles

Abstract:

Purpose:

To observe the tumor responses during photodynamic therapy in a murine glioblastoma model using chemical exchange saturation transfer (CEST) MRI and to compare the treatment effectiveness between single photodynamic therapy (sPDT) and repeated PDT (rePDT).

Methods:

After tumor cell implantation in NSG mouse brain (n = 27), mice were subjected to four PDT sessions (rePDT), sPDT after the administration of 5‐aminolevulinic acid 6 h before each session, and a non‐PDT session (control). A 630‐nm LED light was used to effectuate PDT. After 24 h for each PDT session, T2‐weighted and CEST MRI were performed over 7 days.

Results:

We observed that rePDT resulted in a continuous suppression of tumors according to T2‐weighted images; thus, the tumor volume was the smallest among three groups on Day 7. Both CEST contrasts at 3.5 ppm (amide proton transfer, APT) and 3.5 ppm (relayed nuclear Overhauser enhancement, rNOE) in the rePDT group were significantly lower (p < 0.05) than those in the control group starting from Day 5, which corresponds to lower protein and cellularity in tumors in the rePDT group, respectively. CEST contrast decreased by 17.9% at 3.5 ppm and 11.3% at 3.5 ppm for rePDT group. This was validated by histology, where we observed moderate correlations between APT with cell proliferation (R = 0.730, p < 0.01) and cell apoptosis (R = 0.715, p < 0.05) and moderate correlation between rNOE with cellularity (R = 0.796, p < 0.01).

Conclusions:

rePDT has a better effect in tumor growth suppression when compared with sPDT, and CEST could be a robust and noninvasive mean to assess the molecular changes related to treatment efficacy.

01 Apr 2025·Photodiagnosis and Photodynamic Therapy

Pigmented pathological type and depth of follicular extension as predictors of treatment failure in 5-aminolevulinic acid photodynamic therapy for actinic keratosis: A retrospective, matched nested case-control study

Article

Author: Chen, Huyan ; Chen, Lianjun ; Chen, Shujun ; Luan, Jing ; Wu, Wenyu ; Zhu, Qinyuan ; Huang, Qiong

BACKGROUND:

While 5-Aminolevulinic acid photodynamic therapy (ALA-PDT) is widely used to treat actinic keratosis (AK), treatment resistance and recurrence after ALA-PDT remain clinical challenges.

METHODS:

This single-site, retrospective, matched case-control study included 119 patients with histologically confirmed AK to identify clinical and pathological predictors for effectiveness of ALA-PDT. Patients received four consecutive ALA-PDT sessions at intervals of 1 or 2 weeks. Initial complete clearance (ICC) at 3 months and sustained complete clearance (SCC) at 12 months were assessed. Case patients were those with treatment-resistant or recurrent AK, matched with controls based on age, sex, and the treatment date. Baseline characteristics were collected and compared between the case and control groups.

RESULTS:

ICC at 3 months was achieved in 106 out of 119 patients (89.07%), with 65 out of 82 patients (79.27%) maintaining SCC at 12 months. Pigmented AK emerged as an independent predictor of treatment resistance (OR=44.05, p=0.00). Furthermore, follicular extension to the isthmus or deeper was significantly associated with recurrence within 1 year (OR=17.26, p=0.00).

CONCLUSION:

Pigmented AK and AK with follicular extension to the isthmus or deeper may serve as independent predictors of treatment resistance and recurrence, respectively. These findings highlight the importance of these specific features when assessing prognosis and tailoring treatment strategies for individual AK patients.

01 Apr 2025·Photodiagnosis and Photodynamic Therapy

Comparison of photodynamic therapy and LEEP in women of reproductive age with cervical squamous intraepithelial neoplasia 2 (CIN2): A prospective observational study in China

Article

Author: Li, Cheng ; Cui, Qiulin ; Chen, Ming ; Wang, Xuanhui ; He, Mian

BACKGROUND:

Non-invasive treatments, such as 5-Aminolevulinic acid photodynamic therapy (5-ALA-PDT), has gained increasing attention among women with cervical intraepithelial neoplasia grade 2 (CIN2) who have fertility requirements. To compare the effectiveness of 5-ALA-PDT and loop electrosurgical excision procedure (LEEP) in patients with CIN2, we conducted this prospective cohort study in Chinese patients with CIN2.

METHODS:

229 patients with CIN2 were enrolled. They were divided into the PDT Group (n=94) and LEEP Group (n=135) according to the patient's willingness. Patients were evaluated at the 3-, 6-, 12- and 18-month follow-up periods, using cytology, HPV testing, and colposcopy examination.

RESULTS:

At the 3-month follow-up, the rates of disease regression to normal or CIN1 in the PDT group were 76.6% (72/94) and 13.8% (13/94), respectively, whereas in the LEEP group, they were 80.7% (109/135) and 11.1% (15/135), respectively. Logistic regression analysis revealed that the transformation zone type 3 was the only risk factor for both the PDT (OR=3.68; 95% CI, 2.43-5.26; P=0.008) and LEEP groups (OR=2.34; 95% CI, 1.84-4.53; P=0.02). The treatment efficacy in the PDT group increased gradually and peaked at the 18-month follow-up point with disease disappearance and regression rates of 90.4% and 8.5%, respectively. The disease disappearance and regression rates in the LEEP group were highest at the first half year posttreatment, with disease disappearance and regression rates of 87.4% and 12.6%, respectively. The hrHPV-negative rates in the PDT group and LEEP group were the highest at the 18-month follow-up (78.7% and 74.8%). There was no significant difference in the disappearance or regression rates between the two groups at the follow-up points (P > 0.05).

CONCLUSIONS:

Our study revealed that both 5-ALA PDT therapy and LEEP were highly effective at treating CIN2. 5-ALA-PDT, as a non-invasive treatment, could be an effective option for CIN2 patients with fertility preservation needs.

News (Medical) associated with Aminolevulinic Acid Hydrochloride

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

23 Dec 2024

·www.globenewswire.com

Biofrontera Inc. Announces 100 RhodoLED® XL Machines Now Placed in US Market

Biofrontera started commercial distribution of the RhodoLED XL in June 2024 and has seen rapid uptake in the US market since launch.The RhodoLED XL is approved by the FDA in combination with Ameluz® (aminolevulinic acid hydrochloride) topical gel, 10% for photodynamic therapy (PDT) of actinic keratoses of mild-to-moderate severity on the face and scalp.Biofrontera’s RhodoLED XL and BF-RhodoLED lamps deliver red light energy using long-lasting light-emitting diode (LED) arrays. WOBURN, Mass., Dec. 23, 2024 (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 100th commercial RhodoLED® XL Lamp has now been installed in the US market. The RhodoLED XL was approved by the FDA for use in combination with Ameluz® in 2022 and was launched in June of this year. Since then, it has seen rapid adoption by offices who had previously used Ameluz and those who are new to the product, with 100 now being installed since launch. The main difference between the company’s existing BF-RhodoLED lamp and the new RhodoLED XL is the number of LED panels which allows a larger surface area to be illuminated during a single PDT treatment with Ameluz®. “We are delighted that the RhodoLED XL Lamp has had such an enthusiastic reaction from dermatologists who perform PDT, with more than 10% of offices using Ameluz already installing one” said Dr Hermann Luebbert, CEO and Chairman of Biofrontera Inc. “It is remarkable to have placed this many in such a short span of time post launch, and our customers have been very complimentary about the level of service we have delivered both in the lead up to installation, and with the training and support afterwards,” he continued. After a three-month evaluation of the RhodoLED XL, Dr. Aaron Hoover of Front Range Dermatology, Colorado was so impressed with its performance that his practice decided to purchase not one but two units, including the 100th installed RhodoLED XL lamp. “We were thoroughly impressed by the lamp’s robust yet elegant design, as well as its exceptional maneuverability and adjustability, which made it ideal for Photodynamic Therapy (PDT) treatments in our offices,” Dr. Hoover explained. “The larger illumination area has significantly increased our patient throughput while also enhancing the overall quality of care and patient experience.” Dr. Hoover also noted the high level of satisfaction among both staff and patients with the outcomes of using Ameluz PDT in conjunction with the RhodoLED XL. “Additionally, the Biofrontera team made the purchase and transition to the XL an entirely seamless process for us,” he added. “We were pleased to receive FDA approval for the use of up to 3 tubes of Ameluz® in one treatment in October of this year” stated Dr Luebbert. “With this capability and the larger illumination area of the RhodoLED XL our physicians can now treat a larger surface area on the face and scalp at one time which is efficient for the office and convenient for their patients” he concluded. 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.21. https://www.skincancer.org/skin-cancer-information/basal-cell-carcinoma/2. https://www.skincancer.org/skin-cancer-information/actinic-keratosis/ 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 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 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

Drug Approval

03 Dec 2024

·www.accesswire.com

Biofrontera Inc. to Present at The Benchmark Company's Upcoming Discovery One-on-One Investor Conference

WOBURN, MA / ACCESSWIRE / December 3, 2024 / Biofrontera Inc. (Nasdaq:BFRI) ("Biofrontera" or the "Company"), a biopharmaceutical company specializing in the development and commercialization of photodynamic therapy (PDT), today announced it will be presenting at The Benchmark Company's 13th Annual Discovery One-on-One Investor Conference to be held Wednesday, December 11th, 2024 at the New York Athletic Club in New York City.The conference offers emerging growth and dynamic publicly traded companies access to institutional and individual investors in a unique one-on-one format during which Biofrontera will be participating in one-on-one meetings with investors and analysts throughout the day.To schedule a one-on-one meeting with Biofrontera, you may submit your request online via the registration link provided. To register for the conference, please visit https://www.meetmax.com/sched/event_112571/investor_reg_new.html?attendee_role_id=INVESTORAbout 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 Actinic Keratosis (AK), pre-cancerous skin lesions which may progress to invasive skin cancers1. 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.1 - https://www.skincancer.org/skin-cancer-information/actinic-keratosis/About The Benchmark CompanyThe Benchmark Company is an institutionally focused, research driven, sales trading and investment banking firm. It was founded in 1988 and are headquartered in New York City. Its focus is on fostering the long-term success of corporate clients through raising capital, providing strategic advisory services, generating insightful research, and developing institutional sponsorship by leveraging the firm's sales, trading, and equity research capabilities. https://www.benchmarkcompany.com.Contacts Investor RelationsAndrew Barwicki1-516-662-9461[email protected]Forward-Looking StatementsCertain statements in this press release may constitute "forward-looking statements" within the meaning of the United States Private Securities Litigation Reform Act of 1995. These statements include, but are not limited to, statements relating to the Company's revenue guidance, business and marketing strategy, revenue growth, sales force productivity, growth strategy, liquidity and cash flow, potential to expand the label of Ameluz®, available market opportunities for Ameluz®, ongoing clinical trials, educational outreach efforts, and other statements that are not historical facts. The words "intends," "may," "will," "plans," "expects," "anticipates," "projects," "predicts," "estimates," "aims," "believes," "hopes," "potential", "target", "goal", "assume", "would", "could" or similar words are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. 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, our reliance on sales of products we license from other companies as our sole source of revenue; the success of our competitors in developing generic topical dermatological products that successfully compete with our licensed products; the success of our principal licensed product, Ameluz®; the ability of the Company's licensors to establish and maintain relationships with contract manufacturers that are able to supply the Company with enough of the licensed products to meet our demand; the ability of our licensors or their manufacturing partners to supply the licensed products that we market in sufficient quantities and at acceptable quality and cost levels, and to fully comply with current good manufacturing practice or other applicable manufacturing regulations; the ability of our licensors to successfully defend or enforce patents related to our licensed products; the availability of insurance coverage and medical expense reimbursement for our licensed products; the impact of legislative and regulatory changes; competition from other pharmaceutical and medical device companies and existing treatments, such as simple curettage and cryotherapy; the Company's ability to achieve and sustain profitability; the Company's ability to obtain additional financing as needed to implement its growth strategy; the Company's ability to retain and hire key personnel; and other factors that may be disclosed in the Company's filings with the Securities and Exchange Commission ("SEC"), which can be obtained on the SEC 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 undertake 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.SOURCE: Biofrontera Inc.

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	JP	SBI Pharmaceuticals Co., Ltd.	27 Sep 2017
Glioblastoma Multiforme	AU	Specialised Therapeutics Glio Pty Ltd	07 Nov 2013
Contrast agents	JP	Nobelpharma Co., Ltd.	25 Mar 2013
Basal Cell Carcinoma	EU	Biofrontera Bioscience GmbH	13 Dec 2011
Basal Cell Carcinoma	IS	Biofrontera Bioscience GmbH	13 Dec 2011
Basal Cell Carcinoma	LI	Biofrontera Bioscience GmbH	13 Dec 2011
Basal Cell Carcinoma	NO	Biofrontera Bioscience GmbH	13 Dec 2011
Glioma	EU	Photonamic GmbH & Co. KG	07 Sep 2007
Glioma	IS	Photonamic GmbH & Co. KG	07 Sep 2007
Glioma	LI	Photonamic GmbH & Co. KG	07 Sep 2007
Glioma	NO	Photonamic GmbH & Co. KG	07 Sep 2007
Condylomata Acuminata	CN	Shanghai Fudan Zhangjiang Bio Pharmaceutical Co., Ltd.	14 Feb 2007
Actinic Keratosis	US	DUSA Pharmaceuticals, Inc.	03 Dec 1999
Actinic Keratosis	US	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	CN	Shanghai Fudan Zhangjiang Bio Pharmaceutical Co., Ltd.	20 Jan 2025
Ovarian Epithelial Carcinoma	Phase 3	US	NX Development Corp.	30 May 2024
Recurrent ovarian cancer	Phase 3	US	NX Development Corp.	30 May 2024
Breast Cancer	Phase 3	US	Sbi Alapharma Canada, Inc.	27 Apr 2021
Carcinoma	Phase 3	US	Sbi Alapharma Canada, Inc.	27 Apr 2021
Meningioma	Phase 3	US	NX Development Corp.	28 Oct 2020
Meningioma	Phase 3	AT	NX Development Corp.	28 Oct 2020
Meningioma	Phase 3	DE	NX Development Corp.	28 Oct 2020
Superficial basal cell carcinoma	Phase 3	US	Biofrontera Bioscience GmbH	25 Sep 2018
Malignant glioma of brain	Phase 3	JP	Nobelpharma Co., Ltd.	01 Aug 2010

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


TMOD-04 (SNO2024)	Phase 1	-	8	Sonodynamic Therapy with 5-ALA HCL Oral Solution and CV-01	rldefbossx(oknvapfcbq) = qwbwitwduk nmwixscpxp (hlxsczyhfg )	Positive	11 Nov 2024
				5-ALA HCL oral solution (Control Group)	rldefbossx(oknvapfcbq) = jeendudnaf nmwixscpxp (hlxsczyhfg )
NCT01128218 (Phase 2 Sensitivity and Selectivity Study, Pubmed \| Oper Neurosurg (Hagerstown))	Phase 2	Recurrent Glioblastoma	31	High-dose 5-ALA (>40 mg/kg)	sjugbpasqy(codzkractc) = vdkapltndc sbssltgtmq (hlghvjhfci ) View more	Positive	11 Nov 2024
				Low/standard dose 5-ALA (<30 mg/kg)	sjugbpasqy(codzkractc) = cejyaerncs sbssltgtmq (hlghvjhfci ) View more
NCT03573401 (ALA-BCC-CT013, GlobeNewswire) Manual	Phase 3	Basal Cell Carcinoma	187	Ameluz®-PDT	jycaqcskhn(xaswlvcrrg) = ltjmgspzan zqobboxfqu (dageafwyzq ) View more	Positive	31 Oct 2024
				Placebo-PDT	jycaqcskhn(xaswlvcrrg) = ilndmxrgnp zqobboxfqu (dageafwyzq ) View more
P10.22.B (EANO2024)	Not Applicable	Glioma	163	5-ALA (Fluorescent Gliomas)	cvrcbbezxo(mzgbxizppn) = xppugrhizl rqtkigqyjz (ipbcfgqkgj ) 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)	webisjwmbe(yemyipgkan) = rmdmiyembb nczedxjbvm (gqkuylzvei ) View more	Negative	17 Oct 2024
				5-aminolevulinic acid (5-ALA) (Focal residual 5-ALA)	webisjwmbe(yemyipgkan) = tkinsaourm nczedxjbvm (gqkuylzvei ) 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)	wvisuqvnuu(degtkpfzcg) = recerqvzat phaaazzzyx (ulhzaogjia ) View more	Positive	01 Jul 2024
NCT03327831 (CTgov)	Phase 4	Actinic Keratosis	30	Aminolevulinic Acid	eebztprdav(uxdbifxlll) = fftxcnbepx rbsygljgtp (sqflbbxcrl, ttttfituiz - nuoyhzlbts) View more	-	27 Jun 2024
MP77-20 (AUA2024)	Not Applicable	Non-Muscle Invasive Bladder Neoplasms	33	Fluorescence cystoscopy using oral 5-aminolevulinic acid (ALA)	earkuzwyeb(dxwbkwmbbp) = bebvcndhsi fvjvilclsr (ilyoqrlnvd ) View more	Positive	01 May 2024
				5-aminolevulinic acid (White-light endoscopy)	earkuzwyeb(dxwbkwmbbp) = cjvcmfzrkh fvjvilclsr (ilyoqrlnvd ) View more
PD30-02 (AUA2024)	Not Applicable	Bladder Cancer	302	Fluorescence cystoscopy using oral 5-aminolevulinic acid (ALA)	rfaurcmdyn(rxcnkeucpw) = szgpigpkxh kkwixlsujx (nmiugpwvlo ) View more	Negative	01 May 2024
				5-AMINOLEVULINIC ACID (White light cystoscopy)	rfaurcmdyn(rxcnkeucpw) = tuunlqcsbx kkwixlsujx (nmiugpwvlo ) View more

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Aminolevulinic Acid Hydrochloride

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