Ameluz 10% Topical Gel — Competitive Intelligence Brief

Ameluz 10% Topical Gel (Ameluz 10% Topical Gel) competitive landscape: 6 comparators, recent regulatory actions, upcoming PDUFA, patent timeline. Class: Photodynamic therapy agent. Area: Dermatology/Oncology.

marketed Photodynamic therapy agent Protoporphyrin IX (photosensitizer) Dermatology/Oncology Small molecule

Target snapshot

Ameluz 10% Topical Gel (Ameluz 10% Topical Gel) — Psoriasis Treatment Center of Central New Jersey. Ameluz is a topical photodynamic therapy agent that generates reactive oxygen species upon light activation to destroy abnormal skin cells.

Comparator set (6 drugs)

Drug	Generic	Sponsor	Phase	Class	Target	Approval / PDUFA
Ameluz 10% Topical Gel TARGET	Ameluz 10% Topical Gel	Psoriasis Treatment Center of Central New Jersey	marketed	Photodynamic therapy agent	Protoporphyrin IX (photosensitizer)
BF-200 ALA cream	BF-200 ALA cream	Joint Authority for Päijät-Häme Social and Health Care	marketed	Photodynamic therapy agent	Protoporphyrin IX (photosensitizer generated from aminolevulinic acid)
TOOKAD VTP	TOOKAD VTP	Steba Biotech S.A.	marketed	Photodynamic therapy agent	Vascular endothelial cells (non-receptor mediated phototoxicity)
Placebo to BF-200 ALA gel	Placebo to BF-200 ALA gel	Biofrontera Bioscience GmbH	phase 3	Photodynamic therapy agent	Protoporphyrin IX (via aminolevulinic acid metabolism)
Physician's Choice SOC	Physician's Choice SOC	Rakuten Medical, Inc.	phase 3	X-ray activated photodynamic therapy agent
NDL-PDT	NDL-PDT	Galderma R&D	phase 3	Photodynamic therapy agent
SUCLEAR®	SUCLEAR®	National Cancer Center, Korea	phase 3	Photodynamic therapy agent

Recent regulatory actions (last 90 days)

No regulatory actions in the last 90 days for this set.

Upcoming PDUFA dates (next 180 days)

No PDUFA dates in the next 180 days for this set.

Patent timeline (forward window)

No upcoming patent expiries for this set.

Sponsor landscape (Photodynamic therapy agent class)

1. Galderma R&D · 3 drugs in this class
2. DUSA Pharmaceuticals, Inc. · 2 drugs in this class
3. Biofrontera Bioscience GmbH · 2 drugs in this class
4. Steba Biotech S.A. · 2 drugs in this class
5. National Cancer Center, Korea · 1 drug in this class
6. Photocure · 1 drug in this class
7. Psoriasis Treatment Center of Central New Jersey · 1 drug in this class
8. Joint Authority for Päijät-Häme Social and Health Care · 1 drug in this class