Clinical Trials

Numerous clinical trials evaluate protoporphyrin IX across dermatological and hematological indications, primarily focusing on erythropoietic protoporphyria, iron deficiency anemia, and actinic keratosis. Spanning Phase 1 through Phase 4, these investigations are sponsored by both academic medical centers and commercial biopharmaceutical companies. Recruitment status across these trials varies, currently encompassing completed, recruiting, active not recruiting, and enrolling by invitation protocols.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT07123363 WITHDRAWN
Protoporphyria
Wake Forest University Health Sciences
 2026-01 PHASE1
NCT07729579 RECRUITING
Actinic Keratosis (AK)
Sun Pharmaceutical Industries Limited
 2026-08-04 PHASE1
NCT05308472 COMPLETED
Erythropoietic Protoporphyria
Disc Medicine, Inc
 2022-10-31 PHASE2
NCT05883748 Enrolling by invitation
Erythropoietic Protoporphyria
Disc Medicine Inc
 2023-08-31 Phase 2|Phase 3
NCT05308472 Active not recruiting
Erythropoietic Protoporphyria
Disc Medicine Inc
 2022-10-31 Phase 2
NCT04319159 COMPLETED
Actinic Keratoses
Biofrontera Bioscience GmbH
 2020-03-05 PHASE1
NCT04221126 COMPLETED
Normal Skin
Merete Haedersdal
 2019-04-29 PHASE4
NCT01550705 TERMINATED
Erythropoietic Protoporphyria (EPP); X Linked Erythropoietic Protoporphyria
University of Utah
 2012-03
NCT02372370 COMPLETED
Healthy
Bispebjerg Hospital
 2014-12 PHASE1

(data from https://clinicaltrials.gov, updated on 2026-01-29)

Check the Protoporphyrin IX (PPIX) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

As a central heterocyclic tetrapyrrole intermediate in the heme biosynthetic pathway, protoporphyrin IX selectively chelates ferrous iron or absorbs specific light wavelengths to generate cytotoxic intracellular reactive oxygen species. This photoactivation triggers targeted membrane peroxidation and cellular apoptosis, providing the pharmacological rationale for photodynamic therapy in actinic keratosis and serving as a critical diagnostic and therapeutic focal point in erythropoietic protoporphyria and iron deficiency anemia.

Appendix RUO and cGMP Quality Standards

Quality Dimension RUO (Research Use Only) cGMP (Current Good Manufacturing Practice)
Clinical Applicability Prohibited in human clinical trials or medical diagnostics. Mandatory for human clinical trials (Phase I–III) and therapies.
Regulatory Status Non-regulated grade; exempt from drug manufacturing laws. Legally enforced by health authorities (e.g., FDA, EMA, NMPA).
Facility Environment Unclassified analytical or research laboratories. Validated Cleanrooms (ISO Class 5–8) with continuous monitoring.
Quality Control Basic purity and activity testing. Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma).
Process Validation Basic equipment calibration; no process validation required. Full qualification (IQ/OQ/PQ) and complete batch records.
Quality Assurance Vendor self-declared without required formal QMS. Mandatory QA/QC unit, Change Control, CAPA, and vendor audits.
Regulatory Impact High risk of IND rejection if used as a critical raw material. Required for IND/NDA filings, supported by Drug Master Files (DMF).

Footnotes

Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).

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Note: Technical data last updated: Sep 1, 2026.