Hypericin Clinical Trials

Size	Price	Qty
1mg	USD 147
5mg	USD 370

Clinical Trials

Multiple clinical trials evaluate the therapeutic potential of synthetic hypericin formulations across diverse oncological, dermatological, and infectious disease indications, ranging from Phase 1 safety assessments to Phase 3 confirmatory studies. Sponsored by organizations including Soligenix, SystImmune Inc., and the National Institute of Allergy and Infectious Diseases, these studies target conditions such as cutaneous T-cell lymphoma, plaque psoriasis, HIV infections, and advanced solid tumors like non-small cell lung cancer. Across these protocols, recruitment statuses vary—spanning completed, actively recruiting, and terminated trials—reflecting the evolving development landscape of the drug.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT06470451	TERMINATED	CTCL/ Mycosis Fungoides; CTCL; Mycosis Fungoides; Cutaneous T Cell Lymphoma	Soligenix	2025-01-07	PHASE3
NCT05872854	COMPLETED	Cutaneous T Cell Lymphoma; Mycosis Fungoides	Ellen Kim, MD	2023-08-21	PHASE2
NCT05442190	COMPLETED	Psoriasis; Plaque Psoriasis; Psoriasis Vulgaris	Soligenix	2022-12-14	PHASE2
NCT06218940	Not yet recruiting	NSCLC Stage IV	Newsoara Biopharma Co. Ltd.	2024-12-01	Phase 1
NCT06149247	COMPLETED	Cutaneous T-Cell Lymphoma/Mycosis Fungoides	Soligenix	2023-12-05	PHASE2
NCT06094777	Not yet recruiting	Advanced Solid Tumor	Shanghai YingLi Pharmaceutical Co. Ltd.	2023-11-10	Phase 1
NCT05983432	Recruiting	Non Small Cell Lung Cancer\|NSCLC\|Lung Cancer\|Breast Cancer\|Esophageal Cancer\|SCLC\|Small Cell Lung Cancer\|NPC\|Nasopharyngeal Cancer	SystImmune Inc.	2023-08-08	Phase 1
NCT05380635	COMPLETED	Cutaneous T-Cell Lymphoma/Mycosis Fungoides	Soligenix	2022-05-09	PHASE2
NCT02448381	COMPLETED	Cutaneous T-Cell Lymphoma	Soligenix	2015-12	PHASE3
NCT00000792	COMPLETED	HIV Infections	National Institute of Allergy and Infectious Diseases (NIAID)		PHASE1
NCT00000645	COMPLETED	HIV Infections	National Institute of Allergy and Infectious Diseases (NIAID)		PHASE1

(data from https://clinicaltrials.gov, updated on 2026-07-13)

Check the Hypericin product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Hypericin directly binds to and inhibits protein kinase C and monoamine oxidase, blocking downstream phosphorylation cascades and intracellular signaling. This biochemical blockade induces selective apoptosis and halts pathological cell growth, providing the mechanistic rationale for its therapeutic evaluation in cutaneous T-cell lymphoma, plaque psoriasis, and solid tumors.

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>).