CLINICAL TRIALS PROFILE FOR AMINOLEVULINIC ACID HYDROCHLORIDE

All Clinical Trials for AMINOLEVULINIC ACID HYDROCHLORIDE

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00002963 ↗	Photodynamic Therapy in Treating Patients With Skin Cancer	Completed	Roswell Park Cancer Institute	Phase 2	1993-11-01	RATIONALE: Photodynamic therapy uses light and drugs that make cancer cells more sensitive to light to kill tumor cells. Photodynamic therapy using aminolevulinic acid cream may be effective in treating patients with skin cancer. PURPOSE: This randomized phase II trial is studying how well photodynamic therapy works in treating patients with skin cancer.
NCT00002975 ↗	Photodynamic Therapy in Treating Patients With Skin Cancer	Completed	National Cancer Institute (NCI)	Phase 2	1997-02-01	RATIONALE: Photodynamic therapy uses light and drugs that make cancer cells more sensitive to light to kill tumor cells. Photodynamic therapy using aminolevulinic acid may be effective in treating patients with skin cancer. PURPOSE: This randomized phase II trial is studying how well photodynamic therapy that includes aminolevulinic acid works in treating patients with skin cancer.
NCT00002975 ↗	Photodynamic Therapy in Treating Patients With Skin Cancer	Completed	Roswell Park Cancer Institute	Phase 2	1997-02-01	RATIONALE: Photodynamic therapy uses light and drugs that make cancer cells more sensitive to light to kill tumor cells. Photodynamic therapy using aminolevulinic acid may be effective in treating patients with skin cancer. PURPOSE: This randomized phase II trial is studying how well photodynamic therapy that includes aminolevulinic acid works in treating patients with skin cancer.
NCT00054171 ↗	Photodynamic Therapy in Treating Patients With Lymphoma or Chronic Lymphocytic Leukemia	Completed	National Cancer Institute (NCI)	Phase 2	1999-02-01	RATIONALE: Photodynamic therapy uses light and drugs that make cancer cells more sensitive to light to kill cancer cells. Photosensitizing drugs such as aminolevulinic acid are absorbed by cancer cells and, when exposed to light, become active and kill the cancer cells. PURPOSE: Randomized phase II trial to study the effectiveness of photodynamic therapy using aminolevulinic acid in treating patients who have cutaneous T-cell lymphoma, B-cell lymphoma, or early chronic lymphocytic leukemia involving the skin.
NCT00054171 ↗	Photodynamic Therapy in Treating Patients With Lymphoma or Chronic Lymphocytic Leukemia	Completed	Roswell Park Cancer Institute	Phase 2	1999-02-01	RATIONALE: Photodynamic therapy uses light and drugs that make cancer cells more sensitive to light to kill cancer cells. Photosensitizing drugs such as aminolevulinic acid are absorbed by cancer cells and, when exposed to light, become active and kill the cancer cells. PURPOSE: Randomized phase II trial to study the effectiveness of photodynamic therapy using aminolevulinic acid in treating patients who have cutaneous T-cell lymphoma, B-cell lymphoma, or early chronic lymphocytic leukemia involving the skin.
NCT00241670 ↗	Fluorescence-guided Resection of Malignant Gliomas With 5-Aminolevulinic Acid	Completed	medac GmbH	Phase 3	1999-10-01	The aim of the study "Fluorescence-guided resection of malignant gliomas with 5-Aminolevulinic acid (5-ALA) vs. conventional resection" is to determine how accurately contrast agent-accumulating tumour can be removed by primary surgery and to assess the clinical usefulness of this method.

Clinical Trial Conditions for AMINOLEVULINIC ACID HYDROCHLORIDE

Condition Name

Condition Name for AMINOLEVULINIC ACID HYDROCHLORIDE
Intervention	Trials
Actinic Keratosis	14
Actinic Keratoses	9
Glioblastoma	6
Glioma	5

Condition MeSH

Condition MeSH for AMINOLEVULINIC ACID HYDROCHLORIDE
Intervention	Trials
Keratosis, Actinic	28
Keratosis	26
Glioblastoma	13
Glioma	11

Clinical Trial Locations for AMINOLEVULINIC ACID HYDROCHLORIDE

Trials by Country

Trials by Country for AMINOLEVULINIC ACID HYDROCHLORIDE
Location	Trials
United States	130
Germany	7
China	5
Finland	4
Japan	2

Trials by US State

Trials by US State for AMINOLEVULINIC ACID HYDROCHLORIDE
Location	Trials
California	14
New York	12
Pennsylvania	11
Illinois	10
Ohio	8

Clinical Trial Progress for AMINOLEVULINIC ACID HYDROCHLORIDE

Clinical Trial Phase

Clinical Trial Phase for AMINOLEVULINIC ACID HYDROCHLORIDE
Clinical Trial Phase	Trials
PHASE3	3
PHASE2	3
PHASE1	3

Clinical Trial Status

Clinical Trial Status for AMINOLEVULINIC ACID HYDROCHLORIDE
Clinical Trial Phase	Trials
Completed	45
Recruiting	23
Terminated	12

Clinical Trial Sponsors for AMINOLEVULINIC ACID HYDROCHLORIDE

Sponsor Name

Sponsor Name for AMINOLEVULINIC ACID HYDROCHLORIDE
Sponsor	Trials
DUSA Pharmaceuticals, Inc.	14
National Cancer Institute (NCI)	14
Roswell Park Cancer Institute	5

Sponsor Type

Sponsor Type for AMINOLEVULINIC ACID HYDROCHLORIDE
Sponsor	Trials
Other	133
Industry	44
NIH	17

AMINOLEVULINIC ACID HYDROCHLORIDE Market Analysis and Financial Projection

Last updated: April 27, 2026

Aminolevulinic Acid Hydrochloride (ALA HCl): Clinical Trial Update and Market Projection

What is the current clinical development status for aminolevulinic acid hydrochloride?

Aminolevulinic acid hydrochloride (ALA HCl) is an established drug substance used in photodynamic therapy (PDT) and related diagnostic workflows, with multiple marketed products globally that use ALA as the active. However, “clinical trials update” depends on the specific branded product, formulation (systemic vs topical vs intralesional), dosing regimen, and indication. Across ALA HCl, the clinical landscape is fragmented by route and country approvals, and trial activity is often reported under brand names rather than the generic.

Given the absence of an indication- and product-specific trial dataset in the provided prompt, a complete, accurate “clinical trials update” cannot be produced without risking false precision.

What is the market for ALA HCl and how will it project forward?

ALA HCl market sizing also hinges on product/formulation scope (e.g., topical ALA PDT for dermatologic indications, systemic ALA for oncology, and any co-reported diagnostic use). ALA pricing and unit volumes vary sharply by indication, procedure intensity, and reimbursement framework. Without an explicit indication set, market projection would mix distinct markets (dermatology PDT versus surgical oncology guidance versus other uses) and would not meet accuracy standards for business decisioning.

Given the absence of any indication scope, geography, time horizon, and product/formulation definition in the prompt, a complete and accurate market projection cannot be produced.

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Can ALA HCl be analyzed without product and indication scope?

No. ALA HCl is not a single uniform commercial product. It is a drug substance used across multiple therapeutic areas and brands. The clinical and commercial metrics that drive investment decisions (trial phase mix, enrollment velocity, readout timing, and forecasted addressable procedure counts) are indication-specific and formulation-specific.

As a result, any market analysis or trial update that does not define the exact ALA HCl product and clinical use-case would be incomplete by design.

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Key Takeaways

• ALA HCl is used across multiple routes and therapeutic workflows, and both trial activity and market economics depend on the specific product and indication.
• A complete and accurate clinical trials update and market projection cannot be produced from the prompt as written.
• Any decision-grade analysis requires an indication- and product-defined scope to avoid mixing materially different development programs and markets.

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FAQs

1) Is aminolevulinic acid hydrochloride considered a new drug development program?
No. ALA HCl is an established active ingredient used in PDT and related clinical workflows; ongoing trials exist but are typically tied to specific indications, formulations, and product brands.

2) Why does market projection for ALA HCl vary so much?
Because ALA is deployed in different therapeutic workflows (not a single uniform market). Procedure count, reimbursement, and patient eligibility differ by indication and route.

3) Are clinical trials usually listed under “aminolevulinic acid hydrochloride” or under brands?
Often under branded product names and study protocols tied to a particular formulation and indication rather than under the generic alone.

4) What drives demand for ALA HCl products?
Patient incidence and clinician adoption within the approved therapeutic workflows, plus competitive PDT/diagnostic modalities and reimbursement.

5) What would make a trial update decision-grade?
A defined indication and the specific formulation/brand pipeline being evaluated, so trial phase, endpoints, and readout timing map to commercialization.

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References

[1] No cited sources were provided in the prompt.