Aminolevulinic Acid
Diagnostic / imaging agent targets HMOX1 via activation
Regulatory milestones approvals, filings & regulatory actions · 6 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed parapharyngeal meningioma 1 milestone | |||||
| Filed | EU (EMA) | Gliolan | parapharyngeal meningioma | 2026-08-24 | “EMA will be evaluating the scientific content of their Type II Variation for Gliolan® (5-aminolevulinic acid hydrochloride, 5-ALA)” photonamic.de ↗ |
| Approved Indication not stated 4 milestones | |||||
| Label expansion | US (FDA) | AMELUZ | — | 2024-10-04 | fda.gov ↗ |
| Label expansions (2) | US (FDA) | LEVULAN | — | 2010-03-12 – 2018-03-06 | fda.gov ↗ |
| Approved | EU (EMA) | Gliolan | — | 2007-09-07 | europa.eu ↗ |
| Approved | US (FDA) | LEVULAN | — | 1999-12-03 | fda.gov ↗ |
Trials 116 · started per year
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 04 trials | ||||||
| Phase 0 | NCT07038278 | Apr 2026 → Nov 2027 expected | soft tissue sarcoma | University of Colorado, Denver | Not yet recruiting | No outcome recorded |
| Phase 0 | NCT07076472 | Aug 2025 → Dec 2026 expected | glioblastoma | Mayo Clinic | Recruiting | No outcome recorded |
| Phase 0 | NCT03281811 | Nov 2017 → Feb 2020 | mycosis fungoides | Mayo Clinic | Completed | No outcome recorded |
| Phase 0 | NCT00663910 | Mar 2008 → Oct 2009 | skin carcinoma | The Cleveland Clinic | Terminated | No outcome recorded |
| Phase 122 trials | ||||||
| Phase 1 | NCT07862647 | Oct 2026 → Oct 2027 expected | glioblastoma | Alpheus Medical, Inc. | Recruiting | No outcome recorded |
| Phase 1 | NCT07756671 | Aug 2026 → Jun 2027 expected | fungal infection of the toenail | The University of Texas Health Science Center, Houston | Active not recruiting | No outcome recorded |
| Phase 1 | NCT07053852 | Jun → Dec 2025 | actinic keratosis, radiation-induced disorder | Sherrif Ibrahim | Completed | No outcome recorded |
| Phase 1 | NCT06665724 | Jan 2025 → Feb 2026 | anaplastic astrocytoma, anaplastic oligodendroglioma, glioblastoma | University of Münster | Completed | No outcome recorded |
| Phase 1 | NCT06623201 | Oct 2024 → Dec 2026 expected | basal cell carcinoma | Nathalie Zeitouni | Recruiting | No outcome recorded |
| Phase 1 | NCT06252727 | Jul 2024 → Feb 2026 | soft tissue sarcoma | University of California, Davis | Withdrawn | No outcome recorded |
| Phase 1 | NCT06039709 | Jan 2024 → Dec 2026 expected | glioblastoma | Shayan Moosa, MD | Recruiting | No outcome recorded |
| Phase 1 | NCT05362409 | Jun 2022 → Dec 2024 | malignant glioma | Alpheus Medical, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT04044898 | Jan → Jul 2021 | acne | Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd. | Completed | No outcome recorded |
| Phase 1 | NCT04381806 | Jul 2020 → Feb 2027 | neoplasm | Fox Chase Cancer Center | Suspended | No outcome recorded |
| Phase 1 | NCT04319159 | Mar → Sep 2020 | actinic keratosis | Biofrontera Bioscience GmbH | Completed | No outcome recorded |
| Phase 1 | NCT02191488 | Jul 2014 → Dec 2025 overdue | brain neoplasm | David W. Roberts | Active not recruiting | No outcome recorded |
| Phase 1 | NCT01502605 | Sep 2012 → May 2015 | astrocytoma (excluding glioblastoma) | Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Terminated | No outcome recorded |
| Phase 1 | NCT01697670 | Sep → Dec 2012 | ulcerative colitis | University of Zurich | Unknown | No outcome recorded |
| Phase 1 | NCT01682811 | Mar 2012 → Oct 2015 | neurofibromatosis type 1 | Harry T Whelan, MD | Completed | No outcome recorded |
| Phase 1 | NCT01611584 | Jun 2010 → Jul 2014 | lung cancer | Dartmouth-Hitchcock Medical Center | Withdrawn | No outcome recorded |
| Phase 1 | NCT01148966 | Jun 2010 → Apr 2012 | adult glioblastoma, anaplastic astrocytoma, anaplastic oligodendroglioma, giant cell glioblastoma +1 | University of Washington | Terminated | No outcome recorded |
| Phase 1 | NCT01689935 | Nov 2009 → Sep 2013 | acne | Massachusetts General Hospital | Completed | No outcome recorded |
| Phase 1 | NCT00978081 | Jan 2009 → Nov 2016 | head and neck cancer, precancerous condition | Abramson Cancer Center at Penn Medicine | Completed | No outcome recorded |
| Phase 1 | NCT00671710 | Apr 2008 → Nov 2010 | malignant glioma | Advocate Hospital System | Completed | No outcome recorded |
| Phase 1 | NCT00571558 | Mar 2008 → Jun 2010 | oral mucosa leukoplakia | National Cancer Institute (NCI) | Terminated | No outcome recorded |
| Phase 1 | NCT00870779 | May 2007 → Jul 2012 | brain neoplasm | David W. Roberts | Completed | No outcome recorded |
| Phase 1/212 trials · 1 met primary | ||||||
| Phase 1/2 | NCT06307548 | Jul 2024 → Jun 2027 expected | colorectal carcinoma | Roswell Park Cancer Institute | Recruiting | No outcome recorded |
| Phase 1/2 | NCT05736406 | Feb 2024 → Mar 2026 overdue | glioblastoma | Hemerion Therapeutics | Active not recruiting | No outcome recorded |
| Phase 1/2 | NCT05590689 | Nov 2022 → Jan 2028 expected | glioblastoma | University of Münster | Recruiting | No outcome recorded |
| Phase 1/2 | NCT04164849 | Nov 2019 → Oct 2023 | Crohn disease | University Hospital, Akershus | Completed | No outcome recorded |
| Phase 1/2 | NCT03109353 | Sep 2017 → Dec 2022 | chronic graft versus host disease, primary cutaneous T-cell lymphoma | St. Olavs Hospital | Completed | No outcome recorded |
| Phase 1/2 | NCT03638622 | Mar 2017 → Oct 2020 | oral cavity cancer | Massachusetts General Hospital | Completed | No outcome recorded |
| Phase 1/2 | NCT02367547 | Mar 2015 → Sep 2018 | basal cell carcinoma | Joint Authority for Päijät-Häme Social and Health Care | Unknown | No outcome recorded |
| Phase 1/2 | NCT02050243 | Feb 2014 → Feb 2016 | central nervous system cancer | Tel-Aviv Sourasky Medical Center | Unknown | No outcome recorded |
| Phase 1/2 | NCT01522677 | Aug 2012 → May 2014 | colon carcinoma | Edward Nelson | Withdrawn | No outcome recorded Stop: Enrollment |
| Phase 1/2 | NCT01128218 | Mar 2011 → Feb 2021 | brain neoplasm | Southern Illinois University | Completed | No outcome recorded |
| Phase 1/2 | NCT00977795 | Sep 2009 → Jan 2010 | brain neoplasm | Endeavor Health | Withdrawn | No outcome recorded |
| Phase 1/2 | NCT00571974 | Jan 2007 → Jan 2012 | erythroplakia, leukoplakia | University of Arkansas | Completed | Met primary |
| Phase 238 trials · 1 met primary | ||||||
| Phase 2 | NCT06907485 | Aug 2027 → Feb 2029 expected | brain neoplasm | Costas Hadjipanayis | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07828704 | Sep 2026 → Dec 2027 expected | kidney cancer | Henry Ford Health System | Recruiting | No outcome recorded |
| Phase 2 | NCT06948552 | Sep 2026 → Dec 2027 expected | renal pelvis/ureter urothelial carcinoma | Henry Ford Health System | Recruiting | No outcome recorded |
| Phase 2 | NCT06876038 | Sep 2026 → May 2028 expected | lichen planus, oral, oral cavity squamous cell carcinoma, oral mucosa leukoplakia | University of Massachusetts, Boston | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07657975 | Sep 2026 → Sep 2028 expected | epilepsy | Hospices Civils de Lyon | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07225621 | Jan 2026 → Dec 2027 expected | glioblastoma | Alpheus Medical, Inc. | Recruiting | No outcome recorded |
| Phase 2 | NCT06678867 | Mar 2025 → Jun 2026 overdue | brain neoplasm | University College, London | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT06577311 | Aug 2024 → Aug 2025 overdue | skin squamous cell carcinoma | The Center for Clinical and Cosmetic Research | Recruiting | No outcome recorded |
| Phase 2 | NCT06159842 | Aug 2023 → Sep 2024 | skin squamous cell carcinoma in situ | The Center for Clinical and Cosmetic Research | Completed | No outcome recorded |
| Phase 2 | NCT04845919 | Feb 2023 → Oct 2024 | glioblastoma | Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta | Completed | No outcome recorded |
| Phase 2 | NCT05080764 | Dec 2021 → Aug 2025 | acne | Biofrontera Inc. | Completed | No outcome recorded |
| Phase 2 | NCT05101798 | Sep 2021 → Dec 2022 | skull base neoplasm | Icahn School of Medicine at Mount Sinai | Terminated | No outcome recorded |
| Phase 2 | NCT03897491 | Sep 2021 → Apr 2026 | glioblastoma | photonamic GmbH & Co. KG | Terminated | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT04469699 | Apr 2021 → Jan 2025 | adult glioblastoma | University Hospital Muenster | Terminated | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT07027670 | Feb 2021 → Jun 2022 | aortic valve disorder, coronary artery disorder, mitral valve disorder | University of Oxford | Completed | No outcome recorded |
| Phase 2 | NCT04738162 | Sep 2020 → Nov 2025 | brain neoplasm | University of Münster | Completed | No outcome recorded |
| Phase 2 | NCT04020653 | Sep 2019 → May 2020 | malaria | Neopharma Japan Co., Ltd. | Withdrawn | No outcome recorded |
| Phase 2 | NCT03606122 | Jul 2018 → Jul 2019 | actinic keratosis | photonamic GmbH & Co. KG | Completed | No outcome recorded |
| Phase 2 | NCT02728388 | Sep 2016 → Dec 2025 | neurofibromatosis type 1 | Donald Basel | Terminated | No outcome recorded |
| Phase 2 | NCT02691923 | Mar 2016 → Dec 2025 overdue | brain cancer | David W. Roberts | Recruiting | No outcome recorded |
| Phase 2 | NCT02628236 | Feb → May 2016 | actinic keratosis | DUSA Pharmaceuticals, Inc. | Completed | No outcome recorded |
| Phase 2 | NCT01445691 | Nov 2015 → Sep 2016 | benign neoplasm of brain, brain cancer, glioblastoma, primary brain neoplasm | Constantinos Hadjipanayis | Withdrawn | No outcome recorded |
| Phase 2 | NCT02355899 | Jan 2015 → Aug 2017 | tinea unguium | photonamic GmbH & Co. KG | Completed | No outcome recorded |
| Phase 2 | NCT02239679 | Sep 2014 → Jul 2016 | actinic keratosis | DUSA Pharmaceuticals, Inc. | Completed | Met primary |
| Phase 2 | NCT01898416 | Jun 2013 → Dec 2023 overdue | desmoid tumor caused by somatic mutation | michal roll | Recruiting | No outcome recorded |
| Phase 2 | NCT01575275 | May 2012 → May 2014 | adult glioblastoma, giant cell glioblastoma, gliosarcoma | Michael Vogelbaum, MD, PhD | Terminated | No outcome recorded |
| Phase 2 | NCT01475955 | Dec 2011 → Nov 2012 | actinic keratosis | DUSA Pharmaceuticals, Inc. | Completed | No outcome recorded |
| Phase 2 | NCT01458587 | Nov 2011 → Jul 2012 | actinic keratosis | DUSA Pharmaceuticals, Inc. | Completed | No outcome recorded |
| Phase 2 | NCT01351519 | May 2011 → Jan 2015 | astrocytoma (excluding glioblastoma), glioblastoma | MultiCare Health System Research Institute | Terminated | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT01403311 | Oct 2010 → Dec 2011 | glioma | Legacy Health System | Unknown | No outcome recorded |
| Phase 2 | NCT01116661 | Aug 2010 → Dec 2017 | glioma | University of California, San Francisco | Terminated | No outcome recorded |
| Phase 2 | NCT00752323 | Dec 2009 → Sep 2018 | central nervous system cancer | Andrew Sloan, MD | Completed | No outcome recorded |
| Phase 2 | NCT00961090 | Sep 2009 → Apr 2015 | glioblastoma | Matthew R Quigley | Completed | No outcome recorded |
| Phase 2 | NCT00747903 | Feb 2008 → Dec 2010 | skin cancer | Laser and Skin Surgery Center of New York | Unknown | No outcome recorded |
| Phase 2 | NCT02799030 | Oct 2006 → Mar 2007 | actinic keratosis | Biofrontera Bioscience GmbH | Completed | No outcome recorded |
| Phase 2 | NCT00054171 | Feb 1999 → Jul 2005 | leukemia, lymphoma | Roswell Park Cancer Institute | Completed | No outcome recorded |
| Phase 2 | NCT00002975 | Feb 1997 → Apr 2009 | epithelial skin neoplasm, precancerous condition | Roswell Park Cancer Institute | Completed | No outcome recorded |
| Phase 2 | NCT00002963 | Nov 1993 → Jun 2007 | skin carcinoma | Roswell Park Cancer Institute | Completed | No outcome recorded |
| Phase 317 trials · 3 met primary | ||||||
| Phase 3 | NCT07144852 | Nov 2025 → Jan 2027 expected | actinic keratosis | Sun Pharmaceutical Industries, Inc. | Recruiting | No outcome recorded |
| Phase 3 | NCT07144345 | Nov 2025 → Jan 2027 expected | actinic keratosis | Sun Pharmaceutical Industries, Inc. | Recruiting | No outcome recorded |
| Phase 3 | NCT06160492 | Apr 2025 → Feb 2026 overdue | — | Lee's Pharmaceutical Limited | Recruiting | No outcome recorded |
| Phase 3 | NCT06417281 | Jun 2024 → Aug 2025 | malignant glioma, porphyria due to ALA dehydratase deficiency | Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd. | Completed | No outcome recorded |
| Phase 3 | NCT05804370 | May 2024 → Sep 2028 expected | ovarian cancer | NX Development Corp | Recruiting | No outcome recorded |
| Phase 3 | NCT05662202 | Dec 2022 → Sep 2025 | actinic keratosis | Biofrontera Inc. | Completed | No outcome recorded |
| Phase 3 | NCT04815083 | Apr 2021 → Oct 2024 | breast cancer | SBI ALApharma Canada, Inc. | Terminated | No outcome recorded Stop: Business |
| Phase 3 | NCT04305470 | Oct 2020 → Nov 2022 | meningioma | NX Development Corp | Completed | Met primary |
| Phase 3 | NCT04636242 | Aug 2019 → Aug 2021 | — | Rothman Institute Orthopaedics | Unknown | No outcome recorded |
| Phase 3 | NCT03573401 | Sep 2018 → Mar 2024 overdue | skin basal cell carcinoma | Biofrontera Inc. | Active not recruiting | No outcome recorded |
| Phase 3 | NCT02137785 | May 2014 → Mar 2015 | actinic keratosis | DUSA Pharmaceuticals, Inc. | Completed | No outcome recorded |
| Phase 3 | NCT02101931 | Mar 2014 → Mar 2016 | bladder transitional cell carcinoma | Princess Al-Johara Al-Ibrahim Cancer Research Center | Completed | No outcome recorded |
| Phase 3 | NCT01811121 | Feb → Mar 2013 | glioblastoma | Hospices Civils de Lyon | Completed | Met primary |
| Phase 3 | NCT01502280 | Nov 2010 → Jan 2018 | glioma | St. Joseph's Hospital and Medical Center, Phoenix | Completed | No outcome recorded |
| Phase 3 | NCT01459393 | Nov 2010 → Nov 2011 | actinic keratosis | Barretos Cancer Hospital | Completed | No outcome recorded |
| Phase 3 | NCT01167322 | Aug 2010 → Dec 2011 | malignant glioma | Nobelpharma | Completed | No outcome recorded |
| Phase 3 | NCT00241670 | Oct 1999 → Jul 2004 | brain cancer, primary brain neoplasm | medac GmbH | Completed | Met primary |
| Phase 410 trials · 1 met primary | ||||||
| Phase 4 | NCT06745999 | May 2023 → May 2025 | actinic keratosis | Psoriasis Treatment Center of Central New Jersey | Unknown | No outcome recorded |
| Phase 4 | NCT05359419 | May 2022 → Aug 2023 | skin neoplasm | Goldman, Butterwick, Fitzpatrick and Groff | Unknown | No outcome recorded |
| Phase 4 | NCT03963102 | Oct 2019 → Mar 2024 | actinic keratosis | Royal Cornwall Hospitals Trust | Terminated | No outcome recorded |
| Phase 4 | NCT04221126 | Apr → Aug 2019 | — | Merete Haedersdal | Completed | No outcome recorded |
| Phase 4 | NCT02647151 | Dec 2015 → Mar 2016 | actinic keratosis | Fundación Instituto Valenciano de Oncología | Unknown | No outcome recorded |
| Phase 4 | NCT02464709 | Jun 2015 → Oct 2017 | actinic keratosis | Joint Authority for Päijät-Häme Social and Health Care | Completed | Met primary |
| Phase 4 | NCT03327831 | Apr 2015 → Feb 2017 | actinic keratosis | University of California, Irvine | Completed | No outcome recorded |
| Phase 4 | NCT02409732 | Apr 2015 → Jul 2017 | actinic cheilitis | Dartmouth-Hitchcock Medical Center | Completed | No outcome recorded |
| Phase 4 | NCT02075671 | Apr 2014 → Aug 2019 | rosacea | George Washington University | Completed | No outcome recorded |
| Phase 4 | NCT01203878 | Sep 2010 → Nov 2011 | actinic keratosis | Tennessee Clinical Research Center | Terminated | No outcome recorded Stop: Enrollment |
| Phase not applicable13 trials | ||||||
| — | NCT05228483 | Nov 2021 → Nov 2023 | vulvar lichen sclerosus | Xijing Hospital | Unknown | No outcome recorded |
| — | NCT07536737 | Sep 2021 → Jan 2023 | lichen planus, oral | Medical University of Bialystok | Completed | No outcome recorded |
| — | NCT02867722 | Dec 2020 → Dec 2021 | actinic keratosis, skin cancer | Brigham and Women's Hospital | Withdrawn | No outcome recorded Stop: Business |
| — | NCT04631250 | Nov 2018 → Jul 2020 | acne | Tel-Aviv Sourasky Medical Center | Completed | No outcome recorded |
| — | NCT03048240 | May 2017 → Apr 2021 | glioblastoma | University Hospital, Lille | Completed | No outcome recorded |
| — | NCT03066843 | Mar 2017 → Aug 2023 | actinic keratosis | Northwestern University | Completed | No outcome recorded |
| — | NCT03025724 | Jan 2017 → Jan 2020 | skin squamous cell carcinoma | Rhode Island Hospital | Unknown | No outcome recorded |
| — | NCT02157623 | Feb → Sep 2016 | nevoid basal cell carcinoma syndrome | Edward Maytin, MD, PhD | Completed | No outcome recorded |
| — | NCT02594644 | Nov 2014 → Jun 2016 | actinic keratosis | University of California, Davis | Completed | Mixed |
| — | NCT02119338 | Feb 2014 → Jun 2017 | glioma | St. Joseph's Hospital and Medical Center, Phoenix | Unknown | No outcome recorded |
| — | NCT01812837 | Jul 2012 → Mar 2014 | actinic keratosis | University of California, Davis | Completed | No outcome recorded |
| — | NCT00814528 | Nov 2007 → Sep 2009 | actinic keratosis | University of Chicago | Withdrawn | No outcome recorded |
| — | NCT00524485 | May 2005 → Jan 2009 | precancerous condition | Roswell Park Cancer Institute | Terminated | No outcome recorded Stop: Enrollment |
| Comparator or background therapy16 trials | ||||||
| Phase 1 | NCT02698293 Background | Dec 2019 → Jan 2023 | anus disorder, in situ carcinoma | Abramson Cancer Center at Penn Medicine | Withdrawn | No outcome recorded |
| Phase 1 | NCT03322293 Background | Dec 2017 → Dec 2018 | actinic keratosis | University of California, San Francisco | Completed | No outcome recorded |
| Phase 1/2 | NCT02755142 Comparator | Feb 2000 → Jun 2001 | brain neoplasm | medac GmbH | Completed | No outcome recorded |
| Phase 2 | NCT04391062 Background | Sep 2021 → Mar 2024 | glioblastoma | University Hospital, Lille | Completed | No outcome recorded |
| Phase 2 | NCT01556009 Comparator | Apr 2012 → Dec 2015 | nevoid basal cell carcinoma syndrome | UCSF Benioff Children's Hospital Oakland | Completed | No outcome recorded |
| Phase 2 | NCT00865878 Comparator | May 2009 → Sep 2011 | actinic keratosis | DUSA Pharmaceuticals, Inc. | Terminated | No outcome recorded |
| Phase 2 | NCT00706433 Comparator | Mar 2007 → Jul 2008 | acne | DUSA Pharmaceuticals, Inc. | Completed | No outcome recorded |
| Phase 3 | NCT02144077 Comparator | Jan 2014 → Nov 2015 | basal cell carcinoma | Biofrontera Bioscience GmbH | Completed | No outcome recorded |
| Phase 3 | NCT02799069 Comparator | Apr 2008 → Aug 2009 | actinic keratosis | Biofrontera Bioscience GmbH | Completed | No outcome recorded |
| Phase 4 | NCT02622594 Comparator | Oct 2015 → Apr 2017 | actinic keratosis | Dermatology, Laser & Vein Specialists of the Carolinas | Completed | No outcome recorded |
| Phase 4 | NCT01491711 Comparator | Aug 2013 → Apr 2015 | superficial multifocal basal cell carcinoma | Maastricht University Medical Center | Unknown | No outcome recorded |
| — | NCT05488860 Background | Jul 2022 → Jun 2024 | keloid, plantar wart | Xiangya Hospital of Central South University | Unknown | No outcome recorded |
| — | NCT02644187 Background | Dec 2015 → Mar 2017 | actinic keratosis | Vastra Gotaland Region | Completed | No outcome recorded |
| — | NCT02379572 Comparator | Jun 2015 → Jun 2020 | glioblastoma | University Hospital Tuebingen | Completed | No outcome recorded |
| — | NCT02481141 Comparator | Jul 2014 → Jul 2015 | type 2 diabetes mellitus | SBI Pharmaceuticals Co, Ltd. | Completed | No outcome recorded |
| — | NCT00814918 Background | Feb 2009 → Feb 2013 | acne | University of Chicago | Withdrawn | No outcome recorded |
News releases announcing trial results or a regulatory action · 14
| Date | Issuer | Release |
|---|---|---|
| 2026-08-24 | photonamic GmbH & Co. KG | Regulatory photonamic GmbH & Co. KG Submits a Variation to extend the indication of Gliolan to the European Medicines Agency (EMA) photonamic.de ↗
This marks the first submission of an additional indication to the EMA since our original approval for Gliolan in adults for visualisation of malignant tissue during surgery for malignant glioma (WHO grade III and IV), in 2007. |
| 2026-01-14 | photonamic GmbH & Co. KG | Regulatory Press Release Orphan Status EU photonamic.de ↗
Photonamic GmbH & Co. KG (Photonamic) today announced that the European Commission has granted Orphan Drug Designation for the company’s 5-aminolevulinic acid (5-ALA) for the diagnosis of ovarian cancer. |
| 2025-10-21 | Hemerion Therapeutics | Results Annual Meeting of the Congress of Neurosurgeons (CNS): Hemerion technology takes center stage hemerion.com ↗
The CNS annual meeting also offered a prime opportunity to present Hemerion’s clinical results in glioblastoma treatment to the neurosurgical community. |
| 2025-04-23 | photonamic GmbH & Co. KG | Results Phase 3 Study of 5-ALA in Meningioma Surgery Meets Primary Endpoint photonamic.de ↗ |
| 2025-03-13 | photonamic GmbH & Co. KG | Regulatory Marketing Authorisation for Gliolan ® granted in Jordan photonamic.de ↗
photonamic GmbH & Co KG (Photonamic) are pleased to announce the approval of Gliolan ® (5-ALA) in Jordan, marking a significant milestone as the first marketing authorisation for this product in the Middle East Region. |
| 2024-02-22 | photonamic GmbH & Co. KG | Regulatory NX Development Corp. Is Granted Orphan-Drug Designation Status by US FDA for Gleolan® in Ovarian and Related Cancers photonamic.de ↗
NX Development Corp. (NXDC) has achieved another milestone as we proudly announce the recent granting of orphan-drug status by the U.S. Food and Drug Administration (FDA) for Gleolan (aminolevulinic acid HCl). |
| 2023-11-13 | FluoGuide A/S | Results FluoGuide announces FG001 meets primary endpoint in phase llb trial in aggressive brain cancer fluoguide.com ↗
All patients receiving FG001 (12/12) or 5-ALA (12/12) had additional cancer detected by optical guidance, showing FG001 was superior to white light |
| 2023-05-09 | Medexus Pharma, Inc. | Results Medexus Demonstrates Cost-Effectiveness of Gleolan-Guided Surgery for High-Grade Glioma medexus.com ↗
Medexus Pharmaceuticals (TSX: MDP) (OTCQX: MEDXF) today presented data demonstrating a 33% cost savings with Gleolan® (aminolevulinic acid HCl) oral solution, compared to conventional white light surgery, in US patients with high-grade glioma. |
| 2021-10-27 | Invion, Inc. | Results Complete Regression of TNBC Tumours and Protective Immunity inviongroup.com ↗
Results showed a complete regression in the tumour and appeared to have triggered an immune response that subsequently prevented the recurrence of TNBC. |
| 2021-10-14 | Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd. | Regulatory 盐酸氨酮戊酸外用散用于治疗光化性角化病获得药物临床试验申请受理通知书 fd-zj.com ↗
审批结论：根据《中华人民共和国行政许可法》第三十二条的规定，经审查，决定予以受理。 |
| 2020-09-10 | Medexus Pharma, Inc. | Regulatory Medexus Reports Health Canada Approval of Gleolan® (5-ALA) for Use in Guided Surgical Resection of High-Grade Gliomas medexus.com ↗
today announces that on September 9, 2020, it received a Notice of Compliance from Health Canada granting approval for the marketing of Gleolan ® in Canada. |
| 2019-11-19 | Medexus Pharma, Inc. | Regulatory Medexus Granted Priority Review Status for Gliolan® by Health Canada medexus.com ↗
Medexus Pharmaceuticals Inc. (the “Company” or “Medexus”) (TSXV: MDP, OTCQB: PDDPF) today announced that Health Canada has granted priority review status for the New Drug Submission (NDS) for Gliolan® (5-aminolevulinic acid hydrochloride). |
| 2019-09-12 | Medexus Pharma, Inc. | Regulatory Medexus Reports Health Quality Ontario Recommends Gliolan® for Public Reimbursement medexus.com ↗
today announced that Health Quality Ontario, under the guidance of the Ontario Health Technology Advisory Committee, has recommended public funding of Gliolan® (5-aminolevulinic acid hydrochloride) for guiding maximal surgical resection of high-grade gliomas in adults, conditional on Health Canada approval. |
| 2017-09-27 | Chugai Pharmaceutical | Regulatory "ALAGLIO ® Divided Granules 1.5g," a Photodynamic Diagnostic Agent Obtained Manufacture and Marketing Approval chugai-pharm.co.jp ↗ |
All press releases naming this drug 19 releases
Evidence & citations 30 cited values
Every value below carries the sentence it was read from. 140 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | aminolevulinic acid | “Aminolevulinic acid 20% solution with blue light photodynamic therapy (ALA-PDT) has previously been shown to be superior to vehicle plus PDT (VEH-PDT) for treatment of AKs of...” PMID 38125671 ↗ Dec 202351“Aminolevulinic Acid (ALA) preparation and administration: The FDA-approved Aminolevulinic Acid (ALA) from Dusa Pharmaceuticals, Inc., Wilmington, Massachusetts (MA) will be...” NCT03638622 ↗ “PDT treatment consists of applying a gel containing aminolevulinic acid hydrochloride (licensed for clinical use as Ameluz®) to the abnormal area.” NCT03963102 ↗ “A Pharmacokinetics and Safety Study of Aminolevulinic Acid Hydrochloride Topical Powder in Subjects With Moderate to Severe Facial Acne Vulgaris.” NCT04044898 ↗ “A Proof of Principle Study of Aminolevulinic Acid (ALA) - Induced Fluorescence Detection in Resectable Non-Small Cell Lung Cancer” NCT01611584 ↗ “Photodynamic therapy with aminolevulinic acid (ALA) 20% topical solution is also an approved treatment for actinic keratoses.” NCT01203878 ↗ “The purpose of this study is to improve the current ECP technology using aminolevulinic acid (ALA) and UV light.” NCT03109353 ↗ “previous severe adverse reaction to topical 20% aminolevulinic acid (Kerastick)” NCT03025724 ↗ “10% aminolevulinic acid gel (Ameluz®, BF-200 ALA)” NCT05662202 ↗ “aminolevulinic acid (ALA)” NCT07756671 ↗ |
| Known as | 5-ALA | “This is a prospective, single-arm feasibility study investigating the use of 5-aminolevulinic acid (5-ALA, Gleolan) to enhance intraoperative tumor visualization in patients...” NCT06948552 ↗38“The patient will receive 5-ALA ( 5-aminolevulinic acid hydrochloride),GLIOLAN drinkable 6h before surgery + lighting of the tumor bed by a red light source (laser with...” NCT04391062 ↗ “patient will be instructed to apply 5-aminolevulinic acid HCL topical solution to their shoulder prior to their surgery. 16 minutes before skin incision a blue light will be...” NCT04636242 ↗ “Only one phase III prospective randomized study, published in 2006, has assessed the performance of 5-aminolevulinic acid (5-ALA) fluorescence-guided surgery (FGS) for...” PMID 37856381 ↗ Oct 2023 “Here, we present a safety and feasibility trial after treating GBM intraoperatively by photodynamic therapy (PDT) after 5-aminolevulinic acid (5-ALA) administration and maximal...” PMID 33743128 ↗ Mar 2021 “5-aminolevulinic acid (5-ALA) is a photosensitizing agent which can induce photochemical reactions in tissues in response to an appropriate wavelength of light (red light 630-635nm).” NCT05228483 ↗ “This study is intended to investigate the utility, safety and efficacy of 5-aminolevulinic acid (5-ALA) induced brain tumor fluorescence during malignant brain tumor resection.” NCT00977795 ↗ “A multifaceted treatment approach can include nutritional supplements with antioxidant properties such as 5-aminolevulinic acid (5-ALA) with sodium ferrous citrate (SFC).” PMID 27738640 ↗ Sep 2016 “BACKGROUND: 5-aminolevulinic acid (5-ALA; GleolanTM, NX Development Corps., Lexington, USA) is approved for fluorescence-guided resections of suspected malignant gliomas.” PMID 36009108 ↗ Aug 2022 “Topical application of BF-200 ALA containing 7.8% 5-ALA (5-aminolevulinic acid) red light photodynamic therapy (PDT) utilizing BF-RhodoLED® after 1h incubation.” NCT05080764 ↗ “5-aminolevulinic acid (5-ALA) has been shown to be valuable in intraoperative marking of various cancers.” NCT02050243 ↗ |
| Known as | 5-ALA HCl | “We report updated, exploratory analyses of OS, PFS, and health-related quality of life (HRQOL) for patients receiving intraoperative photodynamic therapy (PDT) with...” PMID 38753093 ↗ May 20243“5-ALA HCl (5-amino-levulenic acid) for oral solution (20 mg/kg) p.o. 6-8 hours prior to LIDU SDT” NCT07225621 ↗ “or orally administered aminolevulinic acid hydrochloride (5-ALA HCL)” NCT07076472 ↗ “5-aminolevulinic acid hydrochloride (5-ALA HCl, Gliolan®)” NCT06665724 ↗ |
| Known as | 5-ALA, 5-aminolevulic acid hydrochloride | “5-ALA, 5-aminolevulic acid hydrochloride” NCT01167322 ↗ |
| Known as | 5-amino-levulenic acid | “5-ALA HCl (5-amino-levulenic acid) for oral solution (20 mg/kg) p.o. 6-8 hours prior to LIDU SDT” NCT07225621 ↗ |
| Known as | 5-aminolaevulinic acid | “Following topical application of 5-aminolaevulinic acid, the substance is metabolized to protoporphyrin IX, a photoactive compound which accumulates intracellularly in the...” NCT02647151 ↗ |
| Known as | 5-Aminolevulinic acid | “This is a prospective, randomized controlled trial to evaluation the ability of 5-aminolevulinic acid HCL topical solution photodynamic therapy to decrease the colonization of...” NCT04636242 ↗55“The aim of this study is to test the effectiveness and safety of the medicine Ameluz® (5-aminolevulinic acid) in comparison to methyl-aminolevulinate (MAL), used with...” NCT02144077 ↗ “The drug, 5-aminolevulinic acid (ALA), which leads to intracellular accumulation of fluorescent porphyrins in gliomas will be used under investigation for identification and...” NCT01116661 ↗ “Only one phase III prospective randomized study, published in 2006, has assessed the performance of 5-aminolevulinic acid (5-ALA) fluorescence-guided surgery (FGS) for...” PMID 37856381 ↗ Oct 2023 “Here, we present a safety and feasibility trial after treating GBM intraoperatively by photodynamic therapy (PDT) after 5-aminolevulinic acid (5-ALA) administration and maximal...” PMID 33743128 ↗ Mar 2021 “BACKGROUND: 5-aminolevulinic acid (5-ALA; GleolanTM, NX Development Corps., Lexington, USA) is approved for fluorescence-guided resections of suspected malignant gliomas.” PMID 36009108 ↗ Aug 2022 “A multifaceted treatment approach can include nutritional supplements with antioxidant properties such as 5-aminolevulinic acid (5-ALA) with sodium ferrous citrate (SFC).” PMID 27738640 ↗ Sep 2016 “Topical application of BF-200 ALA containing 7.8% 5-ALA (5-aminolevulinic acid) red light photodynamic therapy (PDT) utilizing BF-RhodoLED® after 1h incubation.” NCT05080764 ↗ “5-aminolevulinic acid (5-ALA) fluorescence-guided resection of high-grade gliomas (HGG) increases the extent of resection (EOR) and progression-free survival.” PMID 36656388 ↗ Jan 2023 “The aim of this study is to assess the pharmacokinetics (PK) of the parent drug 5-aminolevulinic acid (ALA) and its active metabolite protoporphyrin IX (PpIX)” NCT04319159 ↗ “This study aims to determine the safety and utility of using 5-Aminolevulinic Acid (ALA) in removing malignant brain tumors during surgery.” NCT01403311 ↗ |
| Known as | 5-aminolevulinic acid HCL | “This is a prospective, randomized controlled trial to evaluation the ability of 5-aminolevulinic acid HCL topical solution photodynamic therapy to decrease the colonization of...” NCT04636242 ↗ |
| Known as | 5-Aminolevulinic Acid hydrochloride | “The patient will receive 5-ALA ( 5-aminolevulinic acid hydrochloride),GLIOLAN drinkable 6h before surgery + lighting of the tumor bed by a red light source (laser with...” NCT04391062 ↗7“We report updated, exploratory analyses of OS, PFS, and health-related quality of life (HRQOL) for patients receiving intraoperative photodynamic therapy (PDT) with...” PMID 38753093 ↗ May 2024 “NPC-07 (5-aminolevulinic acid hydrochloride) induced tissue fluorescence” NCT01167322 ↗ “5-aminolevulinic acid hydrochloride (5-ALA HCl, Gliolan®)” NCT06665724 ↗ “5-Aminolevulinic acid Hydrochloride (Gliolan®)” NCT07828704 ↗ “5-Aminolevulinic acid Hydrochloride (Gliolan®)” NCT06948552 ↗ “5-Aminolevulinic Acid hydrochloride (5-ALA)” NCT07027670 ↗ |
| Known as | 5-aminolévulinique acid | ClinicalTrials.gov intervention name — accepted as the source's own label NCT01811121 ↗ |
| Known as | ALA | “The drug, 5-aminolevulinic acid (ALA), which leads to intracellular accumulation of fluorescent porphyrins in gliomas will be used under investigation for identification and...” NCT01116661 ↗26“The objective of this study was to detect 5-aminolevulinic acid (ALA)-induced tumor fluorescence from glioma below the surface of the surgical field by using red-light illumination.” PMID 28777025 ↗ Aug 2017 “Individual lesions on patients within each stratum are randomized to receive either a 4-5 or 18-24 hour application of aminolevulinic acid (ALA).” NCT00002975 ↗ “This study aims to determine the safety and utility of using 5-Aminolevulinic Acid (ALA) in removing malignant brain tumors during surgery.” NCT01403311 ↗ “The nanoemulsion-based 10% aminolevulinic acid (ALA) hydrochloride gel BF-200 ALA optimizes epidermal penetration of its active ingredient” PMID 34633154 ↗ Oct 2021 “A Proof of Principle Study of Aminolevulinic Acid (ALA) - Induced Fluorescence Detection in Resectable Non-Small Cell Lung Cancer” NCT01611584 ↗ “topically applied aminolevulinic acid (ALA) into the lesions of patients with primary basal cell and squamous cell carcinomas.” NCT00002963 ↗ “Photodynamic therapy with aminolevulinic acid (ALA) 20% topical solution is also an approved treatment for actinic keratoses.” NCT01203878 ↗ “PDT involves the topical application of aminolevulinic acid (ALA), or one of its derivatives, as a photosensitizing agent.” NCT03322293 ↗ “Aminolevulinic acid (ALA) is a naturally occurring metabolite in the synthesis of pathway of cellular heme production.” NCT04636242 ↗ “20% aminolevulinic acid HCL (ALA) applied topically for 90 +/- 30 minutes prior to treatment with 10 j/cm2 blue light.” NCT00865878 ↗ |
| Known as | ALA HCl | “Reformulated Levulan Kerastick containing aminolevulinic acid hydrochloride (ALA HCl), 20%” NCT07144345 ↗ |
| Known as | Ameluz | “PDT treatment consists of applying a gel containing aminolevulinic acid hydrochloride (licensed for clinical use as Ameluz®) to the abnormal area.” NCT03963102 ↗6“A 0,25mm-thick layer of BF-200 ALA (aminolevulinic acid, Ameluz®) light sensitizer gel is applied on one randomized treatment side of face.” NCT02464709 ↗ “AMELUZ® (aminolevulinic acid hydrochloride) gel, 10%” NCT05359419 ↗ “10% aminolevulinic acid gel (Ameluz®, BF-200 ALA)” NCT05662202 ↗ “BF-200 ALA 10% gel (Ameluz®)” NCT04319159 ↗ |
| Known as | Aminolevulinic acid (ALA) | “Aminolevulinic acid (ALA)” NCT03638622 ↗ |
| Known as | aminolevulinic acid HCL | “A Pharmacokinetic Study of Levulan Kerastick (Aminolevulinic Acid HCl) for Topical Solution, 20% Under Maximal Use Conditions” NCT02628236 ↗5“20% aminolevulinic acid HCL (ALA) applied topically for 90 +/- 30 minutes prior to treatment with 10 j/cm2 blue light.” NCT00865878 ↗ “Drug intervention: Aminolevulinic acid HCl (ALA) topical solution 20%” NCT03322293 ↗ “LEVULAN® KERASTICK® (aminolevulinic acid HCl) topical solution, 20%” NCT05359419 ↗ “aminolevulinic acid HCL (ALA)” NCT06623201 ↗ |
| Known as | aminolevulinic acid HCL (ALA) | “Levulan® Kerastick® containing 20% aminolevulinic acid HCL (ALA, active study drug)” NCT00706433 ↗ |
| Known as | aminolevulinic acid hydrochloride | “Participants will have their facial Cutaneous Squamous Cell Carcinoma in situ (SCCis) prepped then treated with Aminolevulinic acid hydrochloride 10% topical gel (Ameluz ®),...” NCT06577311 ↗8“AMINOLEVULINIC ACID HYDROCHLORIDE (ALA) gel 78mg/g. Intervention: Just one application of the product in the actinic keratosis lesions before the photodynamic therapy” NCT02647151 ↗ “Reformulated Levulan Kerastick containing aminolevulinic acid hydrochloride (ALA HCl), 20%” NCT07144345 ↗ “AMELUZ® (aminolevulinic acid hydrochloride) gel, 10%” NCT05359419 ↗ “Drug: aminolevulinic acid hydrochloride” NCT00571558 ↗ |
| Known as | BF-200 ALA | “A 0,25mm-thick layer of BF-200 ALA (aminolevulinic acid, Ameluz®) light sensitizer gel is applied on one randomized treatment side of face.” NCT02464709 ↗3“The nanoemulsion-based 10% aminolevulinic acid (ALA) hydrochloride gel BF-200 ALA optimizes epidermal penetration of its active ingredient” PMID 34633154 ↗ Oct 2021 “10% aminolevulinic acid gel (Ameluz®, BF-200 ALA)” NCT05662202 ↗ “Drug: BF200-ALA/5-aminolevulinic acid” NCT02644187 ↗ |
| Known as | Gleolan | “This is a prospective, single-arm feasibility study investigating the use of 5-aminolevulinic acid (5-ALA, Gleolan) to enhance intraoperative tumor visualization in patients...” NCT06948552 ↗3“The combination of 5-ALA (Gleolan) and LIFU is collectively known as sonodynamic therapy (SDT).” NCT06039709 ↗ |
| Known as | Gliolan | “an investigational agent, known as 5-ALA or Gliolan (aminolevulinic acid), that many be useful to a surgeon for visualizing a tumor during surgery” NCT01575275 ↗13“5-aminolevulinic acid hydrochloride (Gliolan), orally, 40 mg/kg administered approximately 4-6 hours before light administration.” NCT02698293 ↗ “3 millimolar 5 aminolevulinic acid (Gliolan®) in combination with blue-light (405 nanometer) photopheresis” NCT04164849 ↗ “patient will receive 5-ALA (5- alanine ,GLIOLAN drinkable) 4h before surgery” NCT03048240 ↗ “5-aminolevulinic acid hydrochloride (5-ALA HCl, Gliolan®)” NCT06665724 ↗ “5-aminolevulinic acid (5-ALA) (also known as Gliolan)” NCT01502605 ↗ “5-Aminolevulinic acid Hydrochloride (Gliolan®)” NCT07828704 ↗ “5-Aminolevulinic acid Hydrochloride (Gliolan®)” NCT06948552 ↗ “5-ALA (Gliolan)” NCT07657975 ↗ “5-ALA (Gliolan)” NCT06678867 ↗ |
| Known as | Kerastick | “topical 20% 5-ALA (Levulan Kerastick; DUSA Pharmaceuticals) to the SCCis” NCT03025724 ↗ |
| Known as | Levulan | ClinicalTrials.gov intervention name — accepted as the source's own label NCT02157623 ↗ |
| Known as | Levulan Kerastick | “reformulated Levulan Kerastick (aminolevulinic acid HCl 20%) combined with photodynamic therapy (PDT) for field-directed treatment of actinic keratosis (AK) on the face or bald scalp.” NCT07144345 ↗2“20% 5-ALA Levulan Kerastick will be crushed and prepared for application after shaking for at least 3 minutes.” NCT00814918 ↗ “LEVULAN® KERASTICK® (aminolevulinic acid HCl) topical solution, 20%” NCT05359419 ↗ |
| Known as | Levulan Kerasticks (aminolevulinic acid 20% solution) | “Levulan Kerasticks (aminolevulinic acid 20% solution)” NCT01203878 ↗ |
| Known as | Levulan KerastickTM | “5-Aminolevulinic Acid (Levulan KerastickTM)” NCT00571974 ↗ |
| Known as | NPC-07 | “NPC-07 (5-aminolevulinic acid hydrochloride) induced tissue fluorescence” NCT01167322 ↗ |
| Action | Activate | “to induce haem oxygenase-1 (HO-1)” NCT07027670 ↗ |
| Modality | Other / unclassified | “Photodynamic therapy with 5-aminolevulinic acid and pulsed dye laser” PMID 22106236 ↗ Nov 2011 |
| Route | Topical | “Aminolevulinic acid is topically applied” NCT00002963 ↗ |
| Target | HMOX1 | “to induce haem oxygenase-1 (HO-1)” NCT07027670 ↗ |