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Report Overview
Fibrodysplasia ossificans progressiva (FOP) is a very rare inherited connective tissue disorder in which muscles, tendons, and ligaments gradually ossify into bone. According to the National Organization for Rare Disorders (NORD), its prevalence is estimated at 1 in 1,000,000. The FOP drug pipeline is witnessing growing focus on therapies targeting disease progression and flare-up prevention. According to the fibrodysplasia ossificans progressiva pipeline analysis by Expert Market Research, the market is expected to grow in the coming years, driven by increased clinical research, emerging targeted therapies, and heightened awareness of this debilitating condition.
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Major companies involved in the fibrodysplasia ossificans progressiva pipeline analysis include Ashibio Inc., Clementia Pharmaceuticals Inc., and others.
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Leading drugs currently in the pipeline include IPN60130, INCB000928, AZD0530 Difumarate, and others.
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The pipeline is expected to expand with increased clinical trials targeting ACVR1 inhibitors and anti-inflammatory therapies. Emerging gene-editing approaches and combination treatments are likely to drive significant advancements in disease management.
Report Coverage
The Fibrodysplasia Ossificans Progressiva Pipeline Analysis Report by Expert Market Research gives comprehensive insights into fibrodysplasia ossificans progressiva therapeutics currently undergoing clinical trials. It covers various aspects related to the details of each of these drugs under development for fibrodysplasia ossificans progressiva. The fibrodysplasia ossificans progressiva report assessment includes the analysis of over 100 pipeline drugs and 50+ companies. The fibrodysplasia ossificans progressiva 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 fibrodysplasia ossificans progressiva 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 fibrodysplasia ossificans progressiva.
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Fibrodysplasia Ossificans Progressiva Pipeline Outlook
Fibrodysplasia ossificans progressiva is a rare, autosomal dominant disorder in which connective tissues, including muscles, tendons, and ligaments, gradually ossify into bone. This abnormal bone formation leads to severe movement restrictions, deformities, and progressive disability, significantly impacting patients’ quality of life. The condition is caused by mutations in the ACVR1 gene, which disrupts normal bone growth regulation.
Fibrodysplasia ossificans progressiva treatments focus on reducing heterotopic ossification, managing flare-ups, and improving mobility. Sohonos (palovarotene) is the first FDA-approved therapy, targeting abnormal bone formation while requiring careful monitoring in pediatric and adult patients. Sohonos (palovarotene) emerged as a pioneering therapy, approved by the U.S. Food and Drug Administration in August 2023. It significantly reduces new heterotopic bone formation in patients aged 8 years and older, offering a novel option for a condition with limited treatment alternatives.
Fibrodysplasia Ossificans Progressiva Epidemiology
The fibrodysplasia ossificans progressiva (FOP) drug pipeline is advancing due to the disorder’s rarity and significant unmet need. According to the National Organization for Rare Disorders, fibrodysplasia ossificans progressiva (FOP) is extremely rare, with a global prevalence of approximately 1 in 1,000,000. As per an international survey by Xu et al., 2025, FOP is frequently misdiagnosed, with a worldwide misdiagnosis rate of 87% and an average duration of 4.1 years from symptom onset to confirmed diagnosis, underscoring the need for advanced therapeutic interventions.
Fibrodysplasia Ossificans Progressiva – Pipeline Therapeutic Assessment
This section of the report covers the analysis of fibrodysplasia ossificans progressiva 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 fibrodysplasia ossificans progressiva pipeline analysis report covers 50+ drug analyses based on drug classes:
- Small Molecules
- Monoclonal Antibodies
- Peptides
- Proteins
By Route of Administration
The pipeline assessment report covers 50+ drug analyses based on the route of administration.
- Oral
- Parenteral
- Others
Fibrodysplasia Ossificans Progressiva 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 (with approximately 67%) covers a major share of the total fibrodysplasia ossificans progressiva clinical trials. It is followed by phase III at 34%. These advanced phases indicate significant progress in treatment development, enhancing clinical confidence and attracting investment. Ongoing research and trials in these phases are crucial for addressing the unmet medical needs of FOP patients.
Fibrodysplasia Ossificans Progressiva Pipeline Assessment Segmentation, By Drug Classes
The drug molecule categories covered under the fibrodysplasia ossificans progressiva pipeline analysis include small molecules, monoclonal antibodies, peptides, and proteins. The fibrodysplasia ossificans progressiva report provides a comparative analysis of the drug classes for each drug in various phases of clinical trials for fibrodysplasia ossificans progressiva. Retinoid-based therapies are a key segment in the fibrodysplasia ossificans progressiva treatment landscape. For instance, SOHONOS (palovarotene) is an FDA-approved retinoid, indicated to reduce new heterotopic ossification in patients with FOP. It works by modulating signaling pathways that drive abnormal bone formation, helping to maintain mobility and improve patient outcomes.
Fibrodysplasia Ossificans Progressiva Clinical Trials – Key Players
The EMR report for the fibrodysplasia ossificans progressiva pipeline covers the profile of key companies involved in clinical trials and their drugs under development. It provides a detailed fibrodysplasia ossificans progressiva therapeutic assessment, analyzing the competitive dynamics of the clinical trial landscape. Below is the list of a few players involved in fibrodysplasia ossificans progressiva clinical trials:
- Ashibio Inc.
- Clementia Pharmaceuticals Inc.
- Ipsen
- Incyte Corporation
- AstraZeneca
- Regeneron Pharmaceuticals
- Daiichi Sankyo Co., Ltd.
Fibrodysplasia Ossificans Progressiva – 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 fibrodysplasia ossificans progressiva. It includes product description, trial ID, study type, drug class, mode of administration, and recruitment status of fibrodysplasia ossificans progressiva drug candidates.
Drug: IPN60130
Fidrisertib (IPN60130) is an oral selective ALK2/ACVR1 inhibitor being developed by Clementia Pharmaceuticals Inc. for the treatment of fibrodysplasia ossificans progressiva (FOP), a rare disorder causing abnormal bone formation in soft tissues. This Phase 2 FALKON study is assessing the efficacy and safety of two dosing regimens in adult and pediatric patients. The trial is examining new heterotopic ossification (HO) volume via low-dose Whole Body CT and, for participants aged five and above, [18F]NaF PET-CT scans to monitor lesion progression.
Drug: INCB000928
INCB000928 is an oral investigational drug sponsored by Incyte Corporation, currently being studied in a Phase 2, randomized, double-blind, placebo-controlled trial for participants with fibrodysplasia ossificans progressiva (FOP). The study is examining the drug’s efficacy, safety, tolerability, and pharmacokinetics. INCB000928, also known as zilurgisertib, is designed to inhibit the mutant ALK2 (ACVR1) protein, reducing abnormal bone growth. Preclinical studies are demonstrating strong suppression of heterotopic ossification, high selectivity, and favorable safety profiles.
Drug: AZD0530 Difumarate
Saracatinib is being evaluated in the STOPFOP Phase 2 trial, sponsored by Amsterdam UMC, VUmc, to prevent fibrodysplasia ossificans progressiva. This study is examining the efficacy and safety of AZD0530 Difumarate, a selective ALK2 protein kinase inhibitor, in adults with active FOP. Patients are receiving either 100 mg daily or placebo for six months, followed by an open-label extension. The trial is measuring changes in heterotopic bone formation using CT, PET imaging, and patient-reported outcomes, aiming to prevent abnormal bone growth by targeting FOP-causing ALK2 mutations.
*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 Fibrodysplasia Ossificans Progressiva Pipeline Insight Report
- Which companies/institutions are leading the fibrodysplasia ossificans progressiva drug development?
- Which company is leading the fibrodysplasia ossificans progressiva pipeline development activities?
- What is the current fibrodysplasia ossificans progressiva commercial assessment?
- What are the opportunities and challenges present in the fibrodysplasia ossificans progressiva pipeline landscape?
- What is the efficacy and safety profile of fibrodysplasia ossificans progressiva pipeline drugs?
- Which company is conducting major trials for fibrodysplasia ossificans progressiva drugs?
- Which companies/institutions are involved in Fibrodysplasia Ossificans Progressiva collaborations aimed at providing enhanced therapeutic alternatives for patients?
- What are the geographies covered for clinical trials in fibrodysplasia ossificans progressiva?
Reasons To Buy This Report
The Fibrodysplasia Ossificans Progressiva Pipeline Analysis Report provides a strategic overview of the latest and future landscape of treatments for fibrodysplasia ossificans progressiva. 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 fibrodysplasia ossificans progressiva collaborations, regulatory environments, and potential growth opportunities.
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Report Summary
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