RNA Polymerase Inhibitors Assessment and Forecast: Competition Landscape, Commercial and Pipeline Analysis 2023-2029

RNA polymerase inhibitors are a class of drugs that play a crucial role in suppressing gene transcription by targeting RNA polymerase, the enzyme responsible for synthesizing RNA from DNA templates. These inhibitors act on the active site of RNA polymerase, hindering its ability to catalyze the formation of RNA strands. The most well-known RNA polymerase inhibitors are Rifampicin and Actinomycin D, which primarily target bacterial RNA polymerases. Additionally, Remdesivir, a viral RNA polymerase inhibitor, has gained attention for its potential in treating RNA viruses like SARS-CoV-2. These inhibitors interact with specific receptors or molecules within the RNA polymerase enzyme, disrupting its function and preventing the formation of RNA transcripts. By inhibiting this essential process, RNA polymerase inhibitors impede the expression of viral genes, which can be beneficial in various diseases. RNA polymerase inhibitors find application in treating bacterial infections, particularly tuberculosis, caused by Mycobacterium tuberculosis, and various viral infections, including COVID-19. Moreover, in the field of cancer therapeutics, Actinomycin D has shown promise in targeting cancer cells by inhibiting RNA polymerase activity. According to the World Health Organization (WHO), tuberculosis remains a significant global health concern, with an estimated 10 million new cases and 1.4 million deaths reported in 2019. RNA polymerase inhibitors, like Rifampicin, play a crucial role in combating this infectious disease, offering hope in reducing its burden on public health worldwide. As research progresses, the development of more specific and effective RNA polymerase inhibitors holds the potential to revolutionize treatment approaches for various diseases, ultimately improving patient outcomes. The development and launch of newer products by the market players will significantly enhance the revenue of the RNA polymerase Inhibitors market over the forecast years.

A number of these inhibitors are in the market, while many are in ongoing clinical trials.  22 companies in their pipelines have 18 products in various stages of clinical trials. 2 products are in Phase 4, 3 products are in Phase 3, and 3 products are in Phase 2 of the clinical trials.

Key Developments of RNA Polymerase Inhibitors

• In June 2020, the FDA granted accelerated approval to Zepzelca (turbinectedin) for adult patients with metastatic Non-small Cell Lung Cancer with disease progression on or after platinum-based chemotherapy.
• In January 2020, FDA approved Dificid (fidaxomicin) to treat Clostridium difficile in children aged 6 months or older.

Approved molecules

• Legalon (silibinin)
• Dificid (fidaxomicin)

Drugs in Pipeline

• Zepzelca (lurbinectedin)
• lumicitabine (JNJ-64041575)
• ZSP1273
• ATI-2173
• Onconase (ranpirnase)
• miR 122
• JTK-853
• galidesivir (BCX4430)
• mRNA transfected dendritic cells
• ARB-1467
• TT-034
• ethynylcytidine (TAS-106)
• MGTA-117

Clinical Activity and Developments of RNA Polymerase Inhibitors

As of July 2023, 18 products for 140 diseases are in clinical trials. For instance,

• Hoffmann-La Roche is conducting a Phase 3 clinical trial to evaluate Lurbinectedin in combination with Atezolizumab compared with Atezolizumab as maintenance therapy in participants with Extensive-Stage Small-Cell Lung Cancer (ES-SCLC) following 1^st line induction therapy with Carboplatin, Etoposide, and Atezolizumab that is expected to complete by March 2026.
• VA Office of Research and Development is conducting a Phase 4 clinical trial to determine whether fidaxomicin and vancomycin followed by taper and pulse vancomycin treatment are superior to standard vancomycin treatment for the treatment of recurrent Clostridium difficile infection that is expected to complete by August 2024.
• In May 2023, Guangdong Raynovent Biotech Co., Ltd completed a Phase 3 clinical trial to assess the efficacy and safety of ZSP1273 tablets in treating Acute Uncomplicated influenza A.