Aminolevulinic acid hydrochloride is under clinical development by Shanghai Fudan-Zhangjiang Bio-Pharmaceutical and currently in the Phase II in clinical pathway. The characteristics of the clinical trial as well as other attributes related to the drug, regulations, and company play a fundamental role in ensuring the likelihood of transition that the drug moves from its current development stage to next.

According to GlobalData, the latest event to affect Aminolevulinic acid hydrochloride’s likelihood of approval (LoA) and phase transition for Cervical Intraepithelial Neoplasia (CIN) took place on 28 Jul 2022, which decreased the likelihood that the drug progresses to the next phase in its clinical pathway and decreased the likelihood of final approval for this indication.

GlobalData uses proprietary data and analytics to provide a complete picture of this assessment in their Aminolevulinic acid hydrochloride Likelihood of Approval (LoA) and Phase Transition Success Rate (PTSR) Report.

Aminolevulinic acid hydrochloride overview

Aminolevulinic acid hydrochloride (ALA) is a second generation photodynamic drug. It is formulated as powder for topical route of administration. It is used to treatment for CA traditional areas, fill a gap in urethral orifice CA cure, become the best treatment for CA in preferred therapy.

It is under development for the treatment of cervical intraepithelial neoplasia infected by human papilloma virus (HPV), actinic keratosis, acne. It was also under development for basal cell carcinoma and as adjuvant therapy for the treatment brain gliomas.

Shanghai Fudan-Zhangjiang Bio-Pharmaceutical overview

Shanghai Fudan-Zhangjiang Bio-Pharmaceutical (FDZJ), a subsidiary of Shanghai Pharmaceutical Co Ltd, is a biopharmaceutical company that focuses on research, development, manufacturing and marketing of genetic engineering drugs. It primarily develops genetic engineering drugs, nanotechnology drugs, photodynamic technology drugs, and oral solid preparation technology drugs. The company’s key products include ALA (Aminolevulinic acid Hydrochloride), Hemoporfin for Injection and Doxorubicin liposome among others. It markets products across China. FDZJ is headquartered in Shanghai, China.

Quick View Aminolevulinic acid hydrochloride LOA Data

Report Segments
  • Innovator (NME)
Drug Name
  • Aminolevulinic acid hydrochloride
Administration Pathway
  • Topical
Therapeutic Areas
  • Dermatology
  • Oncology
  • Women’s Health
Key Developers
Highest Development Stage
  • Marketed

GlobalData, the leading provider of industry intelligence, provided the underlying data, research, and analysis used to produce this article.

GlobalData’s Likelihood of Approval analytics tool dynamically assesses and predicts how likely a drug will move to the next stage in its clinical pathway (PTSR), as well as how likely the drug will be approved (LoA). This is based on a proprietary algorithm built from the drugs’ sales forecast, regulatory milestones, cost forecasts, WACC rate and other proprietary data sources found on GlobalData’s Pharmaceutical Intelligence Center.