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 Aug 2026

Sponsor / Collaborator

University of Pittsburgh

[+4]

NCT07225621

/ RecruitingPhase 2

Multi-Center, Randomized, Double-Blind, Placebo-Controlled Trial Comparing Standard of Care Adjuvant Temozolomide With or Without 5-Aminolevulinic Acid (5-ALA) With Concomitant Low Intensity Diffuse Ultrasound (LIDU) Sonodynamic Therapy (SDT) System In Patients With Newly Diagnosed Glioblastoma After Completion of Chemoradiotherapy

The purpose of this research is to test an investigational device using ultrasound along with an investigational drug to see if it is useful in treating glioblastoma following standard of care therapy surgery and chemoradiation. This study is evaluating an experimental treatment for glioblastoma that uses an investigational drug (5-ALA) combined with a non-invasive ultrasound device (LIDU) to target tumor cells. Patients meeting the entry requirements to be in the study, will be equally randomly assigned to receive the study device plus the active study drug plus active ultrasound, or to a "sham" procedure where the ultrasound is not being activated and the study drug is a placebo (looks the same but does not contain active drug). Neither the patient or the investigator will know who is in the active group or not. Both groups will continue to receive the standard therapy of oral Temozolomide.

Start Date01 Jan 2026

Sponsor / Collaborator

Alpheus Medical, Inc.

ChiCTR2500115337

/ Not yet recruitingPhase 4IIT

Melatonin Administration for Alleviating Clinical Symptoms of Burning Mouth Syndrome: An Open-Label, Randomised Controlled Trial

Start Date31 Dec 2025

Sponsor / Collaborator

West China Stomatological Hospital of Sichuan University

100 Clinical Results associated with Aminolevulinic Acid Hydrochloride

100 Translational Medicine associated with Aminolevulinic Acid Hydrochloride

100 Patents (Medical) associated with Aminolevulinic Acid Hydrochloride

6,734

Literatures (Medical) associated with Aminolevulinic Acid Hydrochloride

01 Mar 2026·FREE RADICAL BIOLOGY AND MEDICINE

Genetic traits and diet triggering the iron-induced hepatic model of the idiopathic disorder sporadic porphyria cutanea tarda

Article

Author: Gant, Timothy W ; Vagany, Viktoria ; Davies, Reginald ; Robinson, Susan ; Smith, Andrew G

Metabolic disorders can be the consequence of external factors and individual susceptibility. Sporadic porphyria cutanea tarda (sPCT) is an idiopathic disorder of liver heme synthesis exhibiting inhibition of uroporphyrinogen decarboxylase, characterised by dermal and hepatic deposition of uroporphyrins from oxidation of sensitive uroporphyrinogens (uroporphyria). sPCT is associated with alcohol, estrogenic drugs, HIV and hepatitis C, as well as a poorly understood influence of iron. Hexachlorobenzene (HCB) and reputably 2,3,7,8-tetrachlorodibenzo-p-dioxin (TCDD) cause a similar disorder. The hepatic aspects modelled in susceptible rodents in response to HCB and TCDD are potentiated by iron. Importantly, iron overload alone eventually causes hepatic uroporphyria in genetically susceptible mice. To determine whether this genetic susceptibility to iron toxicity is the consequence of a single genetic variant or is multigenic, a low power F2 intercross cross from sensitive SWR and resistant DBA/2 strains was used to detect chromosomal quantitative trait loci (QTL) associated with uroporphyria development enhanced by the heme precursor 5-aminolevulinic acid (5-ALA). Multiple QTL contributed to the development of uroporphyria. Differential gene expressions comparing mice of parent strains and the F2 extremes of resistance and susceptibility suggested possible contributions associated with QTL. Positions of QTL and the confidence regions were compared with those observed previously for uroporphyria induced more rapidly by TCDD in iron-loaded mice and showed overlapping but not identical loci. A difference in uroporphyric response to iron loading occurred with another sensitive strain, C57BL/10ScSn, whether maintained on one of two well-defined, but similar, same source commercial diets. Uroporphyria developed with a nutritionally enhanced diet rather than a lean maintenance diet. One common observation with uroporphyria was decreased expression of Glul for glutamine synthetase. The findings illustrate the interaction of polygenic factors, external factors and diet in models of idiopathic human disorders such as sPCT.

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 ; Yu, Zichen ; Xu, Qingyang ; 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.

01 Mar 2026·AGEING RESEARCH REVIEWS

RNA G-quadruplexes mediated protein aggregation in neurodegenerative diseases

Review

Author: Tan, Eng King ; Zhou, Zhi Dong ; Liu, Mei ; Liu, Yan ; Guan, Tu Chen ; Mu, Yu Guan ; Zeng, Li ; Wu, Yun-Cheng

RNA G-quadruplexes (rG4s) are stable secondary structures formed by guanine-rich RNA sequences that have emerged as critical regulators of RNA metabolism. The rG4s are widespread in both coding and noncoding RNAs and have been implicated in regulating multiple post-transcriptional processes, including RNA stability, splicing, polyadenylation, nuclear export, localization, and translation. Recent findings reveal that rG4s play pathological roles in neurodegenerative diseases (NDs), including Alzheimer's disease (AD) and Parkinson's disease (PD). The rG4s function in stress granule dynamics, aberrant phase separation, and the nucleation of pathological protein assemblies, which is implicated in protein co-aggregation and pathological protein aggregation in NDs. Here, we provide an integrated synthesis of how rG4s influence protein aggregation through biophysical, cellular, and molecular mechanisms, with particular emphasis on rG4-driven perturbations of phase separation and aggregation pathways. The rG4s relevant disease pathogenesis, biomarker development, and therapeutic interventions in NDs are discussed. Furthermore, we highlight emerging translational opportunities, including the potential of rG4-targeting small molecules such as 5-aminolevulinic acid (5-ALA) and other modulators, which may open new avenues for combating neurodegeneration.

121

News (Medical) associated with Aminolevulinic Acid Hydrochloride

13 Jan 2026

·www.globenewswire.com

Biofrontera Inc. Announces Record Preliminary Fourth Quarter 2025 Revenues between $17.0 Million and $17.5 Million, Representing Approximately 35% Year-Over-Year Growth

Fourth quarter results represent highest quarterly revenue in Company’s historyQ4 year-over-year growth of 35% to 39% driven by sales execution of Ameluz®Full year 2025 revenues also expected to show double-digit growth of 11% to 13% WOBURN, Mass., Jan. 13, 2026 (GLOBE NEWSWIRE) -- Biofrontera Inc. (Nasdaq: BFRI) (“Biofrontera” or the “Company”), a leader in photodynamic therapy (PDT) development and commercialization, today announced preliminary unaudited revenue results for the fourth quarter ended December 31, 2025. Fourth quarter revenues are expected to be between $17.0 million and $17.5 million, representing the highest quarterly revenue in the Company’s history. For the full year 2025, revenues are expected to be in the range of $41.5 million to $42.0 million, reflecting year-over-year growth of approximately 11% to 13%. The Company expects to report complete fourth quarter and full year 2025 financial results in March 2026. Hermann Luebbert, Chief Executive Officer and Chairman of Biofrontera, commented “We are very pleased with our fourth quarter performance which was driven by strong execution across the business, continued growth of Ameluz® PDT and the pricing adjustment introduced in December. Customer adoption and engagement remained strong throughout the quarter, supporting record quarterly revenue performance, validating our strategic approach and setting us up for even stronger momentum throughout 2026. Just as exciting, our recent transformational transaction with Biofrontera AG meaningfully improves our gross margin profile and further strengthens our financial foundation. We’ve never been more energized about the year ahead, and we’re confident that our innovative products, operational excellence, and unwavering commitment to customers will drive continued, sustainable growth.” Results for the quarter and year ended December 31, 2025, have not been finalized and are subject to our financial statement closing procedures. As such, the preliminary unaudited figures described in this press release are subject to change, and actual results may differ. Biofrontera expects to report final, complete fourth quarter and full year financial results for 2025 in March 2026. Details concerning that announcement and conference call will be provided in the coming weeks. Biofrontera management will present at the Lytham Partners Healthcare Investor Summit on January 15, 2026. About Biofrontera Inc. Biofrontera 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, 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/ 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 preliminary financial results, revenue growth, commercial opportunities and the commercial success of its products, 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: 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; 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 products; changes in the practices of healthcare providers, including any changes to the coverage, reimbursement and pricing for procedures using the Company’s 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 RelationsLytham PartnersBen Shamsianshamsian@lythampartners.com646-829-9701

Financial Statement

11 Jan 2026

·www.globenewswire.com

Biofrontera Inc. Announces Data Base Locks for Two Clinical Studies Supporting Key Data and Regulatory Milestones

Database locks for studies on actinic keratosis (AK) and acne vulgaris achieved on January 5, 2026 Data generated will support key regulatory milestones for Ameluz PDT in both indications AK and acne are the two most commonly diagnosed skin disorders in the US1 Jan. 08, 2026 -- Biofrontera Inc. (Nasdaq: BFRI) (“Biofrontera” or the “Company”), a biopharmaceutical company specializing in the development and commercialization of photodynamic therapy (PDT), today announced the successful database lock of two clinical studies evaluating Ameluz® PDT, marking an important milestone ahead of several anticipated data and regulatory events in 2026. The databases for the treatment phase of the Company’s Phase 3 clinical study evaluating Ameluz® PDT for the treatment of actinic keratosis (AK) on the extremities, neck and trunk as well as its Phase 2 clinical study evaluating the treatment of moderate to severe acne vulgaris were successfully locked on January 5, 2026. All data from participants that is collected throughout each study is captured in a specific database. Locking the database enables unblinding and statistical analysis of the study results in accordance with the pre-specified study endpoints. Biofrontera expects data for both studies to be available in February of this year. Actinic keratosis and acne vulgaris are the two skin disorders most commonly diagnosed by dermatologists in the US1, with tens of millions of patients impacted. “Despite the prevalence of AK and acne vulgaris, a large unmet need still exists for the treatment of these common skin conditions. An in-office treatment could significantly improve the compliance rate compared to other therapies for each of these disorders. Growing concerns about antibiotic resistance, systemic safety, and treatment burden have led dermatologists to look at different approaches to prolonged oral antibiotic and isotretinoin use for the treatment of acne2. Together with the large number of AKs appearing on areas of the body other than the face and scalp we believe these two indications have the potential to increase the use of Ameluz PDT substantially if approved,” commented Prof. Hermann Luebbert, Biofrontera’s CEO. Pending positive outcomes of the Phase 3 AK study, the company plans to submit a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) in Summer of 2026 to expand the approved use of Ameluz® PDT for AK beyond the face and scalp. Results from the Phase 2 acne vulgaris study are expected to be presented to the FDA in early Q3 2026 and are intended to provide the basis of a future Phase 3 program, with the goal of achieving approval for Ameluz® PDT in this indication. Together with the submission in December 2025 of the Company’s sNDA for the treatment of superficial Basal Cell Carcinoma (sBCC) with Ameluz® PDT, these milestones support Biofrontera’s strategy to expand the clinical utility of its PDT platform and advance additional growth opportunities. References Peck et al., J Invest Dermatol; Vol 142; (8), S60 Del Rosso JQ et al., J Clin & Aesthet Dermatol. 2019; 12(6):30-41; Habeshian KA, Cohen BA. Current Issues in the Treatment of Acne Vulgaris. Pediatrics. 2020 May;145(Suppl 2):S225-S230; Leyden JJ, J Eur Acad Dermatol Venereol. 2001;15 Suppl 3:51-5. https://investors.biofrontera-us.com/full-news/?qm-storyId=7016033192978791 https://investors.biofrontera-us.com/full-news/?qm-storyId=7994141858240250). 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.5 5. https://www.skincancer.org/skin-cancer-information/actinic-keratosis/ Acne vulgaris is the most common skin condition in the United States, affecting an estimated 50 million people each year¹. Although often associated with adolescence, it persists into adulthood, impacting approximately 40% of adults². The condition ranges from mild blackheads and whiteheads to severe inflammatory forms such as nodules and cysts, which can cause permanent scarring and have profound effects on mental health and self-esteem³. Current U.S. guidelines recommend topical therapies, oral antibiotics, and isotretinoin for moderate to severe acne⁴. However, these treatments are frequently limited by significant systemic side effects, driving demand for safer and more effective alternatives. The U.S. acne treatment market, valued at $5.7 billion in 2024 and projected to grow at a 5.3% CAGR, reflects this unmet need⁵. More than 55% of spending is currently directed to oral antibiotics and isotretinoin⁶, underscoring the reliance on systemic therapies and the opportunity for novel treatment approaches. 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. The content above comes from the network. if any infringement, please contact us to modify.

Clinical Result

18 Dec 2025

·www.globenewswire.com

Biofrontera Inc. Completes Transfer of Ameluz® and RhodoLED® FDA approval and Associated Intellectual Property Portfolio

• Ameluz® and RhodoLED® New Drug Application (NDA) and Investigational New Drug Application (IND) have successfully been transferred to Biofrontera Inc.• Assignment to Biofrontera Inc. of 11 granted US patents, 10 pending US patent applications and various trademarks associated with Ameluz® and the RhodoLED® Lamp Series has been applied for registration with the relevant authorities, including the US Patent Office (USPTO)• In addition, 19 international patent applications and/or registered designs for RhodoLED® lamps outside of the US were acquired and registration of the transfer has been initiated WOBURN, Mass., Dec. 18, 2025 (GLOBE NEWSWIRE) -- Biofrontera Inc. (Nasdaq: BFRI) (“Biofrontera” or the “Company”), a leader in photodynamic therapy (PDT) development and commercialization, today announced the completion of the transfer of the FDA approvals for Ameluz® and the RhodoLED® Lamp Series, including the NDA and the Investigational New Drug Application (IND), to Biofrontera. In addition, the Company has completed all necessary filings to transfer all US and some international intellectual property associated with Ameluz® and the RhodoLED® Lamp Series, including 11 granted US patents, 10 US patent applications, and 19 patent filings or registered designs outside of the US. The registration of the assignment to Biofrontera of all associated trademarks has also been initiated. These asset transfers were secured, in part, by an $11.0 million investment recently reported by the Company. With the NDA and IND transfers effective as of December 17, 2025, Biofrontera now assumes full control of the Ameluz® NDA and IND, enabling the Company to manage ongoing and future clinical development activities independently, and to take full responsibility for all aspects of manufacturing and marketing Ameluz® and the RhodoLED® lamps in the US. The patent and trademark transfers further strengthen Biofrontera’s intellectual property portfolio and market position in the US. “This achievement represents the next important milestone in the transformative arrangement we initiated in June 2025,” said Dr. Hermann Luebbert, CEO and Chairman of Biofrontera. “By consolidating control of Ameluz’s US regulatory filings and its robust patent portfolio, we are positioned to drive operational efficiencies, optimize R&D expenditures, swiftly pursue new indications, and continue refining our RhodoLED® lamp platform — to meet and exceed the evolving needs of clinicians and patients.” About Biofrontera Inc. Biofrontera 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, 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. References1 https://www.skincancer.org/skin-cancer-information/actinic-keratosis/ 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 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; 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 products; changes in the practices of healthcare providers, including any changes to the coverage, reimbursement and pricing for procedures using the Company’s 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 RelationsBen Shamsian646-829-9701shamsian@lythampartners.com

NDA

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.

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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.

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Indication	Highest Phase	Country/Location	Organization	Date
Superficial basal cell carcinoma	NDA/BLA	United States	Biofrontera AG	02 Dec 2025
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

Clinical Result

Indication

Phase

Evaluation

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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)	rmnhxszvkb = clejysnxxy wcxfptuxbw (fjzwmfkqun, twoykvpzpp - ibyxmoqbfy) View more	-	23 Oct 2025
				Red light illumination+Topical aminolevulinate (10% ALA gel) (Regimen B)	rmnhxszvkb = uajdknsvxd wcxfptuxbw (fjzwmfkqun, nntffmzptm - uujglduopr) View more
NCT04815083 (CTgov)	Phase 3	Breast Ductal Carcinoma \| Ductal Carcinoma \| Invasive Lobular Breast Carcinoma ... View more	57	PD G 506 A	ctstswdtwi(rzyrekqufb) = dzpruegiei umxjwubona (uqkvrofelj, pvmxckydoh - uwwmsbtyfg) View more	-	03 Sep 2025
NCT05101798 (CTgov)	Phase 2	Skull Base Neoplasms \| Head and Neck Neoplasms	7	5-Aminolevulinic acid Hydrochloride	uovmjexnsi = jzxnopyflu qdhtrhtlqa (jpiobmkmuc, veuntepvnl - hjecoxxadn) View more	-	28 Jul 2025
NCT03573401 (ALA-BCC-CT013, CTgov)	Phase 3	Superficial basal cell carcinoma	187	ALA (BF-200 ALA)	irkmxlexya = mbxcedzwwi spczogitua (rretnfoufu, qcdjyninsc - nowwopsdhe) View more	-	29 Apr 2025
				Placebo Photodynamic therapy (PDT) (vehicle to BF-200 ALA containing no active ingredient) (Vehicle)	irkmxlexya = huewunynvd spczogitua (rretnfoufu, mvbkluzosm - cstovvplun) 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)	gnvjfvugxc(jnxdrpmsmh) = sswvcytgxb uqrmffofxl (cutlqxywqh ) View more	Positive	11 Nov 2024
				Low/standard dose 5-ALA (<30 mg/kg)	gnvjfvugxc(jnxdrpmsmh) = yqtxnvgewr uqrmffofxl (cutlqxywqh ) View more
TMOD-04 (SNO2024)	Phase 1	-	8	Sonodynamic Therapy with 5-ALA HCL Oral Solution and CV-01	ysliqhycre(pzirclgshq) = ppoikcjgqs gxqveuftcd (msaomqrlcb )	Positive	11 Nov 2024
				5-ALA HCL oral solution (Control Group)	ysliqhycre(pzirclgshq) = hgunlipsda gxqveuftcd (msaomqrlcb )
NCT03573401 (ALA-BCC-CT013, GlobeNewswire) Manual	Phase 3	Basal Cell Carcinoma	187	Ameluz®-PDT	bcelqtvjzu(jlbncxoxbf) = dkoykjijrq olkgxkwjbt (eeuzsxjjfp ) View more	Positive	31 Oct 2024
				Placebo-PDT	bcelqtvjzu(jlbncxoxbf) = unvecmcuuc olkgxkwjbt (eeuzsxjjfp ) 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)	fsmfzzfzag(qxzenlmzfs) = ouygtbkish dytbrdmqiu (kjqlrnijct ) View more	Negative	17 Oct 2024
				5-aminolevulinic acid (5-ALA) (Focal residual 5-ALA)	fsmfzzfzag(qxzenlmzfs) = rxdhyaeeoj dytbrdmqiu (kjqlrnijct ) View more
NCT05060237 (CTgov)	Phase 1	Actinic Keratosis	112	5-ALA (5-aminolevulinic acid)	fljhdxnjws = jswzutofja ociagvonym (teblrfqrxh, bcoerutjpe - sewrnbkvaa) 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)	sbusrvklcv(gyrocvcufk) = ihiciwzckb llkdqgtjtu (lkwvzpqdyx ) View more	Positive	01 Jul 2024

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Synapse data is also accessible to external entities via APIs or data packages. Empower better decisions with the latest in pharmaceutical intelligence.

Bio

Bio Sequences Search & Analysis

Chemical

Chemical Structures Search & Analysis