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Report Overview
X-linked retinitis pigmentosa (XLRP) is a rare, inherited retinal disorder characterized by progressive degeneration of rod photoreceptors, leading to night blindness, peripheral vision loss, and eventual visual impairment. According to Katalin Pungor et al., 2024, retinitis pigmentosa affects approximately 1 in 3,500–4,000 individuals globally, with X-linked forms accounting for nearly 10%-15% of cases. The therapeutic landscape is evolving, with active research in gene augmentation therapies, gene-editing platforms, optogenetic approaches, and retinal implants. According to the X-linked retinitis pigmentosa pipeline analysis by Expert Market Research, increasing research investments, advances in gene delivery technologies, and rising focus on rare genetic ophthalmic disorders are expected to support sustained pipeline expansion and future market growth.
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Major companies involved in the X-linked Retinitis Pigmentosa pipeline analysis include NightstaRx Ltd., Frontera Therapeutics, and others.
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Leading drugs currently in the pipeline include BIIB112, FT-002, AGTC-501, and others.
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The growth in the pipeline is driven by advancing gene replacement therapies, expanded AAV-based delivery platforms, and rising clinical validation of mutation-specific treatments, strengthening late-stage development and commercialization potential in the coming years.
Report Coverage
The X-linked Retinitis Pigmentosa Pipeline Analysis Report by Expert Market Research gives comprehensive insights into X-linked retinitis pigmentosa therapeutics currently undergoing clinical trials. It covers various aspects related to the details of each of these drugs under development for X-linked retinitis pigmentosa. The X-linked retinitis pigmentosa report assessment includes the analysis of over 100 pipeline drugs and 50+ companies. The X-linked retinitis pigmentosa pipeline landscape will include an analysis based on efficacy and safety measure outcomes published for the trials, including their adverse effects on patients suffering from the condition, and alignment with X-linked retinitis pigmentosa treatment guidelines to ensure optimal care practices.
The assessment part will include a detailed analysis of each drug, drug class, clinical studies, phase type, drug type, route of administration, and ongoing product development activities related to X-linked retinitis pigmentosa.
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X-linked Retinitis Pigmentosa Pipeline Outlook
X-linked retinitis pigmentosa is a rare inherited retinal disorder characterized by progressive degeneration of photoreceptor cells. It occurs due to mutations in the retinitis pigmentosa GTPase regulator gene, inherited in an X-linked pattern, primarily affecting males and leading to gradual vision loss and blindness.
X-linked retinitis pigmentosa treatments focus on slowing disease progression and preserving vision through supportive care, retinal implants, and emerging gene therapies designed to restore defective gene function and improve retinal cell survival. In December 2025, Beacon Therapeutics treated the first patient in the LANDSCAPE trial, evaluating bilateral subretinal administration of laru-zova, a gene therapy delivering a functional retinitis pigmentosa GTPase regulator gene for X-linked Retinitis Pigmentosa.
X-linked Retinitis Pigmentosa Epidemiology
The pipeline underscores the importance of precise epidemiological insights in advancing targeted therapies. According to Katalin Pungor et al., 2024, Retinitis Pigmentosa affects nearly 1 in 3,500–4,000 individuals worldwide, with X-linked retinitis pigmentosa representing 10–15% of cases. As per Robert E. MacLaren et al., 2025, the condition predominantly affects males, with an incidence of 3.4–4.4 per 100,000 males. Over 70% of X-linked retinitis pigmentosa cases are associated with retinitis pigmentosa GTPase regulator gene mutations. These epidemiological and genetic insights continue to guide focused drug development efforts in the XLRP pipeline.
X-linked Retinitis Pigmentosa – Pipeline Therapeutic Assessment
This section of the report covers the analysis of X-linked retinitis pigmentosa drug candidates based on several segmentations, including:
By Phase
The pipeline assessment report covers 50+ drug analyses based on phase:
- Late-Stage Products (Phase 3 and Phase 4)
- Mid-Stage Products (Phase 2)
- Early-Stage Products (Phase I)
- Preclinical and Discovery Stage Products
By Drug Class
The X-linked retinitis pigmentosa pipeline analysis report covers 50+ drug analyses based on drug classes:
- Small Molecules
- Monoclonal Antibodies
- Gene Therapies
- Biologics
By Route of Administration
The pipeline assessment report covers 50+ drug analyses based on the route of administration.
- Oral
- Parenteral
- Others
X-linked Retinitis Pigmentosa Pipeline Assessment Segmentation, By Phases
The report covers phase I, phase II, phase III, phase IV, and early-phase drugs. The coverage includes an in-depth analysis of each drug across these phases. According to EMR analysis, phase II covers a major share of the total X-linked retinitis pigmentosa clinical trials, with 47% share, highlighting significant mid-stage development. Phase I follows with 26%, and phase III represents 21% of the pipeline. This balanced distribution across clinical stages indicates robust research activity and promising potential for innovative therapies, positively impacting market growth and patient outcomes.
X-linked Retinitis Pigmentosa Pipeline Assessment Segmentation, By Drug Classes
The drug molecule categories covered under the X-linked retinitis pigmentosa pipeline analysis include small molecules, monoclonal antibodies, gene therapies, and biologics. The X-linked retinitis pigmentosa report provides a comparative analysis of the drug classes for each drug in various phases of clinical trials for X-linked retinitis pigmentosa. Gene therapy is emerging as a leading approach in the X-linked retinitis pigmentosa (XLRP) drug pipeline. For instance, laruparetigene zovaparvovec (laru-zova), an investigational gene therapy expressing the full-length RPGR protein, is under clinical evaluation. It aims to restore photoreceptor function and prevent vision loss. The therapy has received the FDA Regenerative Medicine Advanced Therapy designation, highlighting its potential as a transformative treatment option.
X-linked Retinitis Pigmentosa Clinical Trials – Key Players
The EMR report for the X-linked retinitis pigmentosa pipeline covers the profile of key companies involved in clinical trials and their drugs under development. It provides a detailed X-linked retinitis pigmentosa therapeutic assessment, analyzing the competitive dynamics of the clinical trial landscape. Below is the list of a few players involved in X-linked retinitis pigmentosa clinical trials:
- NightstaRx Ltd.
- Frontera Therapeutics
- Beacon Therapeutics
- Ray Therapeutics, Inc.
- Janssen Research & Development, LLC
- Kiora Pharmaceuticals, Inc.
- Biogen
- MeiraGTx UK II Ltd.
- DSM Nutritional Products, Inc.
- 4D Molecular Therapeutics
X-linked Retinitis Pigmentosa – Emerging Drugs Profile
This section covers the detailed analysis of each drug under multiple phases, including phase I, phase II, phase III, phase IV, and emerging drugs for X-linked retinitis pigmentosa. It includes product description, trial ID, study type, drug class, mode of administration, and recruitment status of X-linked retinitis pigmentosa drug candidates.
Genetic: BIIB112
Cotoretigene toliparvovec (BIIB112) is an investigational AAV8 vector-based retinal gene therapy being developed by NightstaRx Ltd, a Biogen Company, for X-linked retinitis pigmentosa. The Phase 3 SOLSTICE study is evaluating long-term safety and efficacy in patients previously treated with BIIB112. BIIB112 is delivering a functional RPGR gene via subretinal injection, enabling retinal cells to produce RPGR protein. This mechanism aims to stabilize photoreceptor structure, slow retinal degeneration, and preserve visual function, with study completion anticipated in June 2026.
Genetic: FT-002
FT-002 is a recombinant adeno-associated virus (AAV) gene therapy being developed by Frontera Therapeutics for RPGR gene mutation–associated X-linked retinitis pigmentosa. The Phase I/II study is currently recruiting and is evaluating the safety, tolerability, and preliminary efficacy of a one-time subretinal injection. FT-002 is delivering a functional RPGR gene to retinal cells to restore protein expression and repair photoreceptor structure and function. The dose-escalation and expansion phases are examining visual outcomes and disease progression. The study is expected to be completed in February 2026.
Biological: AGTC-501
AGTC-501 (laru-zova) is a recombinant AAV2-based gene therapy being developed by Beacon Therapeutics for X-linked retinitis pigmentosa caused by RPGR mutations. The drug is delivering a full-length, functional RPGR gene via a single subretinal injection, enabling sustained RPGR protein expression to support rod and cone photoreceptor survival and function. This Phase 2, open-label DAWN study is comparing two dose levels to evaluate safety in previously treated patients. Enrollment is by invitation, with primary completion expected in November 2025 and final study completion anticipated by December 2029.
*Please note that this is only a partial list; the complete list of drugs will be available in the full report.*
Key Questions Answered in the X-linked Retinitis Pigmentosa Pipeline Insight Report
- Which companies/institutions are leading the X-linked retinitis pigmentosa drug development?
- Which company is leading the X-linked retinitis pigmentosa pipeline development activities?
- What is the current X-linked retinitis pigmentosa commercial assessment?
- What are the opportunities and challenges present in the X-linked retinitis pigmentosa pipeline landscape?
- What is the efficacy and safety profile of X-linked retinitis pigmentosa pipeline drugs?
- Which company is conducting major trials for X-linked retinitis pigmentosa drugs?
- Which companies/institutions are involved in X-linked retinitis pigmentosa collaborations aimed at providing enhanced therapeutic alternatives for patients?
- What are the geographies covered for clinical trials in X-linked retinitis pigmentosa?
Reasons To Buy This Report
The X-linked Retinitis Pigmentosa Pipeline Analysis Report provides a strategic overview of the latest and future landscape of treatments for X-linked retinitis pigmentosa. It provides necessary information for making informed investment decisions along with research, development, and strategic planning efforts. The stakeholders will benefit from the essential insights into X-linked retinitis pigmentosa collaborations, regulatory environments, and potential growth opportunities.
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Report Summary
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