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Last Updated: April 7, 2025

Mechanism of Action: Cytochrome P450 1A Inducers


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Drugs with Mechanism of Action: Cytochrome P450 1A Inducers

ApplicantTradenameGeneric NameDosageNDAApproval DateTETypeRLDRSPatent No.Patent ExpirationProductSubstanceDelist Req.Exclusivity Expiration
Alembic ALBENDAZOLE albendazole TABLET;ORAL 215652-001 Sep 4, 2024 AB RX No No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
Cipla Ltd ALBENDAZOLE albendazole TABLET;ORAL 210434-001 Sep 21, 2018 DISCN No No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
Dr Reddys ALBENDAZOLE albendazole TABLET;ORAL 211034-001 Jan 26, 2021 AB RX No Yes ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
Edenbridge Pharms ALBENDAZOLE albendazole TABLET;ORAL 211117-001 May 14, 2019 AB RX No No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
Strides Pharma ALBENDAZOLE albendazole TABLET;ORAL 210011-001 Dec 7, 2018 DISCN No No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
>Applicant>Tradename>Generic Name>Dosage>NDA>Approval Date>TE>Type>RLD>RS>Patent No.>Patent Expiration>Product>Substance>Delist Req.>Exclusivity Expiration
Showing 1 to 5 of 5 entries

Cytochrome P450 1A Inducers Market Analysis and Financial Projection

The market dynamics and patent landscape for drugs acting as Cytochrome P450 1A (CYP1A) inducers reflect a niche but evolving sector, driven by both therapeutic applications and challenges in drug development. CYP1A induction plays a critical role in drug metabolism, carcinogen activation, and drug-drug interactions, shaping both opportunities and regulatory considerations.

Market Dynamics

  1. Therapeutic Applications and Challenges

    • Oncology: Chloroxoquinoline (CXL), a CYP1A inducer approved in China for non-small-cell lung cancer and breast cancer, illustrates the dual role of CYP1A induction. While CXL’s efficacy decreases over time due to auto-induction (reducing exposure to its active form), this mechanism highlights the need for careful dosing strategies in chemotherapy[1][17].
    • Dermatology: Dermal CYP1A enhancers like (−)-epicatechin and terpineol are patented to modulate drug bioavailability. For example, co-administration with retinoids (e.g., retinoic acid) could reduce first-pass metabolism in topical treatments[4].
  2. Drug-Drug Interaction (DDI) Risks
    CYP1A induction increases metabolism of co-administered drugs, risking therapeutic failure. Omeprazole and polycyclic aromatic hydrocarbons (PAHs) are known inducers, necessitating rigorous DDI assessments during clinical trials[5][11]. Regulatory guidelines (FDA/EMA) mandate in vitro induction assays, driving demand for services like Cyprotex’s CYP induction screening[5].

  3. Auto-Induction and Drug Development
    Compounds like A-998679 demonstrate auto-induction via aryl hydrocarbon receptor (AhR) activation, accelerating their own clearance. This phenomenon complicates pharmacokinetics, often requiring structural modifications or alternative dosing regimens[17].


Patent Landscape

  1. Key Therapeutic Modalities

    • Small Molecules: Patents cover flavonoids (e.g., α/β-naphthoflavones), terpenoids (e.g., cineole), and tricyclic compounds targeting CYP1A modulation. These agents are explored for cancer chemoprevention or overcoming drug resistance[4][9][10].
    • Biological Agents: Monoclonal antibodies (e.g., MAb 26-7-5) and nucleic acids targeting CYP1A2 highlight innovation in enzyme inhibition, though induction-focused biologics are less prominent[6].
  2. Innovative Formulations and Uses

    • Dermal Enhancers: Patent US20030166583A1 details CYP1A enhancers to improve topical drug delivery, reducing systemic exposure of dermatological agents[4].
    • Cardioprotection: Tricyclic compounds (e.g., furanochromones) are patented to inhibit CYP1A-mediated cardiotoxicity from anthracyclines like doxorubicin[10].
  3. Technological Tools

    • Predictive Models: Computational (Q)SAR models enable early identification of CYP1A inducers, reducing attrition in drug development[12].
    • In Vitro Assays: Services like Cyprotex’s hepatocyte-based induction assays address regulatory requirements for DDI profiling[5].

Competitive and Regulatory Considerations

  • Niche Targeting: Most CYP1A inducers are repurposed from existing drug classes (e.g., flavonoids, PAHs) rather than novel entities, reflecting cautious investment due to toxicity risks[9][15].
  • Regulatory Hurdles: Induction-related DDIs and carcinogen activation (e.g., benzo[a]pyrene) necessitate extensive safety profiling, often limiting clinical translation[15][17].
  • Geographic Trends: China’s approval of CXL contrasts with slower Western adoption, underscoring regional disparities in regulatory tolerance for induction-mediated therapies[1][17].

Future Outlook

  • Precision Induction: Selective AhR modulators could enable tissue-specific CYP1A induction, minimizing systemic effects[17].
  • Companion Diagnostics: Biomarkers for CYP1A activity (e.g., mRNA levels) may personalize dosing of induction-prone drugs[13].
  • Combination Therapies: Co-administering CYP1A inhibitors with inducers could balance efficacy and toxicity, as seen in dermatology applications[4][9].

In summary, the CYP1A inducer market remains specialized, with innovation focused on mitigating auto-induction risks and leveraging induction for targeted therapies. Patent activity underscores ongoing R&D, though clinical adoption hinges on resolving safety and pharmacokinetic challenges[1][4][10][17].

References

  1. https://journals.plos.org/plosone/article?id=10.1371%2Fjournal.pone.0138875
  2. https://patents.google.com/patent/US8263362B2/en
  3. https://pmc.ncbi.nlm.nih.gov/articles/PMC6984740/
  4. https://patents.google.com/patent/US20030166583A1/en
  5. https://www.evotec.com/drug-metabolism/cytochrome-p450-induction
  6. https://patents.google.com/patent/US6335428
  7. https://pubs.acs.org/doi/10.1021/acsomega.2c02315
  8. https://en.wikipedia.org/wiki/Cytochrome_P450
  9. https://pubmed.ncbi.nlm.nih.gov/37337403/
  10. https://patents.google.com/patent/US20210163495A1/en
  11. https://pmc.ncbi.nlm.nih.gov/articles/PMC7764576/
  12. https://pmc.ncbi.nlm.nih.gov/articles/PMC9503090/
  13. https://pmc.ncbi.nlm.nih.gov/articles/PMC6657216/
  14. https://journals.plos.org/plosone/article?id=10.1371%2Fjournal.pone.0070330
  15. https://pubmed.ncbi.nlm.nih.gov/17431034/
  16. https://pmc.ncbi.nlm.nih.gov/articles/PMC2842473/
  17. https://www.frontiersin.org/journals/genetics/articles/10.3389/fgene.2012.00213/full

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