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Levulan

(Aminolevulinic Acid)

ApprovedSmall molecule

Sun Pharmaceutical Industries, Inc.

Aminolevulinic acid is used to treat certain types of skin cancer and precancerous skin lesions, often in combination with a special light therapy that activates the medication to destroy abnormal cells.[2] Levulan is currently approved and in use across 12 indications[4].[1]

Levulan is one of 241 small molecule programs targeting Acne. It is currently in Approved.

12

Indications

24

Total Trials

0

Active Trials

240

Competitors

3

FDA Applications

NDA/BLA/ANDA regulatory filings

13

Patents

Pipeline

Status by Indication[4][1]

Indication

AcneActive, not recruiting

Malignant GliomaApproved

Desmoid-Type FibromatosisApproved

Nevoid Basal Cell Carcinoma SyndromeApproved

Crohn's DiseaseApproved

Colorectal AdenocarcinomaApproved

Malignant Colon NeoplasmApproved

Brain NeoplasmApproved

Neurofibromatosis Type 1Approved

ParagangliomaApproved

AcneApproved

Active, not recruiting

Malignant GliomaApproved

Approved

Desmoid-Type FibromatosisApproved

Approved

Nevoid Basal Cell Carcinoma SyndromeApproved

Approved

Crohn's DiseaseApproved

Approved

Colorectal AdenocarcinomaApproved

Approved

Malignant Colon NeoplasmApproved

Approved

Brain NeoplasmApproved

Approved

Neurofibromatosis Type 1Approved

Approved

ParagangliomaApproved

Approved

Showing 10 of 12 indications

Competition

Competitive Landscape

350 competitors in Treatment

#DrugCompanyPhaseTrials

Levulan

Sun Pharmaceutical Industries, Inc.

Dexilant

Niclocide

Alfenta

Jazz Pharmaceuticals

Hivid

CConrado Roberto Hoffmann Filho

Valium

Akero Therapeutics

Clomid

Aurlumyn

BBTG International Inc.

Barhemsys

Tibotec Pharmaceuticals, Ireland

Norpramin

VValidus Pharmaceuticals

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Clinical

Trials by Indication[1]

Actinic Keratoses3 trials

Study of Daylight Photodynamic Therapy With Aminolevulinic Acid for Actinic Keratoses

Completed·UUniversity of California, Irvine·Phase 4·NCT03327831·30 enrolled

Bilateral Comparison of Treatment of Facial Actinic Keratoses Using Microneedling and Photodynamic Therapy With Aminolevulinic Acid and Blue Light Versus Photodynamic Therapy With Aminolevulinic Acid and Blue Light Using Two Incubation Times

Completed·DDermatology, Laser & Vein Specialists of the Carolinas·Phase 4·NCT02622594·10 enrolled

Daylight PDT for Actinic Keratoses: a Multicentre Study Comparing Two Photosensitizers (BF-200 ALA Versus MAL)

Completed·JJoint Authority for Päijät-Häme Social and Health Care·Phase 4·NCT02464709·72 enrolled

Brain Tumors2 trials

Safety Study of Aminolevulinic Acid (ALA) to Improve Visibility of Brain Tumors During Surgery

Completed·MMatthew R Quigley·Phase 2·NCT00961090·72 enrolled

A Study of Aminolevulinic Acid Used to Enhance Visualization and Surgical Removal of Brain Tumors

Terminated·—·Phase 2·NCT01351519·16 enrolled

Actinic Keratosis2 trials

Controlled Study of the Occurrence of Actinic Keratosis on the Face After Cryotherapy + Aminolevulinic Acid (ALA) Photodynamic Therapy

Completed·DDUSA Pharmaceuticals, Inc.·Phase 2·NCT02239679·166 enrolled

Photodynamic Therapy Using Topical Aminolevulinic Acid in Treating Patients With Actinic Keratosis

Terminated·RRoswell Park Cancer Institute·N/A·NCT00524485·12 enrolled

Systemic2 trials

Maximal Use Systemic Exposure (MUSE) Study of Levulan Kerastick

Completed·DDUSA Pharmaceuticals, Inc.·Phase 2·NCT02281136·29 enrolled

Maximal Use Systemic Exposure Study of Levulan Kerastick (MUSE 2)

Completed·DDUSA Pharmaceuticals, Inc.·Phase 2·NCT02628236·14 enrolled

Skin Cancer2 trials

Photodynamic Therapy in Treating Patients With Skin Cancer

Completed·RRoswell Park Cancer Institute·Phase 2·NCT00002975·180 enrolled

Topical Aminolevulinic Acid in Patients With Nonmelanoma Skin Cancer

Terminated·TThe Cleveland Clinic·Phase 1·NCT00663910·18 enrolled

12 more indications

Glioblastoma Multiforme1 trial

Aminolevulinic Acid in Visualizing a Tumor During Surgery in Patients With Glioblastoma Multiforme

Terminated·MMichael Vogelbaum, MD, PhD·Phase 2·NCT01575275·8 enrolled

Solid Organ Transplant Recipients1 trial

ALA-PDT Versus Vehicle PDT for Treatment of AK and Reduction of New NMSC in Solid Organ Transplant Recipients

Terminated·DDUSA Pharmaceuticals, Inc.·Phase 2·NCT00865878·6 enrolled

Soft Tissue Sarcoma1 trial

Fluorescent Aided Resection and Evaluation of Soft Tissue Sarcomas (FLARES)

Withdrawn·UUniversity of California, Davis·Phase 1·NCT06252727

Safety and Efficacy1 trial

Safety and Efficacy Study of Photodynamic Therapy With Levulan Kerastick + Blue Light for Actinic Keratoses on the Upper Extremities

Completed·DDUSA Pharmaceuticals, Inc.·Phase 3·NCT02137785·269 enrolled

Seborrheic Dermatitis1 trial

Pilot Study for the Use of Photodynamic Therapy in the Treatment of Seborrheic Dermatitis

Completed·UUniversity of California, Davis·Phase 1·NCT03114111·12 enrolled

Malignant Brain Tumors1 trial

Aminolevulinic Acid During Surgery in Treating Patients With Malignant Brain Tumors

Terminated·UUniversity of Washington·Phase 1·NCT01148966·6 enrolled

Astrocytoma1 trial

Imaging Procedure Using ALA in Finding Residual Tumor in Grade IV Malignant Astrocytoma

Completed·—·Phase 2·NCT00752323·73 enrolled

Treatment1 trial

The Use of Microneedles to Expedite Treatment Time in Photodynamic Therapy

Completed·UUniversity of California, Davis·N/A·NCT02594644·32 enrolled

Glial Tumor1 trial

Study of Aminolevulinic Acid to Enhance Visualization and Resection of Malignant Glial Tumors of the Brain

Completed·—·Phase 1·NCT00671710·26 enrolled

Colorectal Cancer1 trial

Fluorescence Image Guided Surgery Followed by Intraoperative Photodynamic Therapy for Improving Local Tumor Control in Patients With Locally Advanced or Recurrent Colorectal Cancer

Suspended·RRoswell Park Cancer Institute·Phase 1/2·NCT06307548·21 enrolled

Neurofibromatosis 11 trial

Topical Photodynamic Therapy (PDT) With Levulan® Kerastick® for Benign Dermal Neurofibromas Phase II

Terminated·DDonald Basel·Phase 2·NCT02728388·30 enrolled

Unspecified2 trials

Twelve Month Follow-Up of CP0108

Completed·DDUSA Pharmaceuticals, Inc.··NCT02209012·206 enrolled

The Use of Microneedles in Photodynamic Therapy

Completed·UUniversity of California, Davis·N/A·NCT01812837·51 enrolled

Regulatory

FDA Approval Timeline[5]

Dec 3, 1999

LEVULAN

NDA NDA020965

May 10, 2016

AMELUZ

NDA NDA208081

Jun 6, 2017

GLEOLAN

NDA NDA208630

Sources

References

[1]
ClinicalTrials.gov — 24 trial records for Aminolevulinic Acid. U.S. National Library of Medicine, National Institutes of Health.
[2]
MedlinePlus Drug Information — Levulan drug information. U.S. National Library of Medicine, National Institutes of Health.
[3]
ChEMBL — Aminolevulinic Acid compound record. European Bioinformatics Institute (EMBL-EBI).
[4]
Open Targets Platform — Drug–disease associations for Aminolevulinic Acid. EMBL-EBI & Wellcome Sanger Institute.
[5]
OpenFDA — FDA approval records (NDA NDA208630). U.S. Food & Drug Administration.
[6]
FDA Orange Book — Patent and exclusivity data for Levulan. U.S. Food & Drug Administration.
[7]
SEC EDGAR — Sun Pharmaceutical Industries, Inc. company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[3]
Highest Phase: Approved[1]
Company: Sun Pharmaceutical Industries, Inc.

Patent Landscape[6]

Patent Cliff

Feb 7, 2028

Earliest patent expiration — generic entry possible after this date

Patent #Expires

11540981Feb 7, 2028

12290700Oct 13, 2036

11697028Oct 13, 2036

11179574Oct 13, 2036

11446512Jan 17, 2037

8 more patents

11135293Jan 12, 2038

11690914Jan 12, 2038

11077192Jan 12, 2038

12296011Jan 12, 2038

10357567Jan 12, 2038

11571478Jan 12, 2038

11235169Oct 15, 2040

12280146Dec 8, 2043

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