Abstract
Objective: Psychiatric drug development is critical for addressing the global burden of mental illness, but the degree of recent innovation is not well understood. Prior studies have highlighted concerns over the stagnation of new therapeutic approaches, particularly compared to other medical specialties. What is the degree of innovation in psychiatric drug development?
Method: This observational study cross referenced 3 drug development databases to identify new and existing therapeutics approved for psychiatric indications between January 1, 2012, and December 31, 2024. To assess each drug’s degree of innovation, the primary outcome was the proportion of drugs classified as “first-in-class” with secondary measures including US Food and Drug Administration (FDA) priority review status, orphan drug designations, inclusion on the WHO’s Model List of Essential Medicines, and therapeutic benefit and clinical usefulness ratings by experts.
Results: A total of 22 new psychiatric drugs and supplemental indications were identified. Of these, 7 (31.8%) were categorized as first-in-class, 2 (9.1%) were considered an advance-in-class, and 13 (59.1%) were considered addition to-class. Three drugs (13.6%) received FDA priority review, 1 (4.5%) was designated as an orphan drug, and 0 were included on the WHO’s Model List of Essential Medicines. For clinical utility, of drugs with available data, none of them received a rating of “clinically helpful,” and 3/22 (13.6%) were rated “clinically not helpful.”
Conclusion: Innovation in psychiatric drug development in the past 13 years was limited, with most new drugs representing incremental advances rather than groundbreaking innovations. Compared to other medical fields, psychiatric drug development appears to lag in terms of novelty and clinical impact.
J Clin Psychiatry 2026;87(1):25m16063
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References (39)
- Moore TJ, Mattison DR. Adult utilization of psychiatric drugs and differences by sex, age, and race. JAMA Intern Med. 2017;177(2):274–275. PubMed CrossRef
- Statistical Brief #539: Healthcare Expenditures for Treatment of Mental Disorders: Estimates for Adults Ages 18 and Older, U.S. Civilian Noninstitutionalized Population, 2019. Accessed May 1, 2025. https://meps.ahrq.gov/data_files/publications/st539/stat539.shtml
- Ahn-Horst RY, Bourgeois FT. Mental health-related outpatient visits among adolescents and young adults, 2006-2019. JAMA Netw Open. 2024;7(3):E241468. PubMed CrossRef
- Wouters OJ, McKee M, Luyten J. Estimated research and development investment needed to bring a new medicine to market, 2009-2018. JAMA, J Am Med Assoc. 2020;323(9):844–853. PubMed CrossRef
- Zhou EW, Jackson MJ, Ledley FD. Spending on phased clinical development of approved drugs by the US National Institutes of Health compared with industry. JAMA Health Forum. 2023;4(7):e231921–e231921. PubMed CrossRef
- Gores M, Lutzmayer S. Fostering Success in CNS Innovation. IQVIA; 2024. https://www.iqvia.com/-/media/iqvia/pdfs/library/white-papers/cns-whitepaper-32024.pdf
- Zhou W, Yang J, Zhang Y, et al. Current landscape of gene-editing technology in biomedicine: applications, advantages, challenges, and perspectives. MedComm. 2022;3(3):e155. PubMed CrossRef
- McGonigle P. How biologics have changed the drug discovery landscape. Annu Rev Pharmacol Toxicol. 2025;65(1):29–46. PubMed CrossRef
- Baldessarini RJ. The impact of psychopharmacology on contemporary psychiatry. Can J Psychiatry. 2014;59(8):401–405. PubMed CrossRef
- Keshavan MS, Lawler AN, Nasrallah HA, et al. New drug developments in psychosis: challenges, opportunities and strategies. Prog Neurobiol. 2017;152:3–20. PubMed CrossRef
- Paul SM, Potter WZ. Finding new and better treatments for psychiatric disorders. Neuropsychopharmacology. 2024;49(1):3–9. PubMed CrossRef
- Régnier S. What is the value of “me-too” drugs?. Health Care Manag Sci. 2013;16(4):300–313. PubMed
- Zhu T. Challenges of psychiatry drug development and the role of human pharmacology models in early development—a drug developer’s perspective. Front Psychiatry. 2020;11:562660. PubMed CrossRef
- Emsley R. The future of psychopharmacology: challenges beyond efficacy and tolerability. World Psychiatry. 2023;22(1):82–83. PubMed CrossRef
- Wong EHF, Yocca F, Smith MA, et al. Challenges and opportunities for drug discovery in psychiatric disorders: the drug hunters’ perspective. Int J Neuropsychopharmacol. 2010;13(9):1269–1284. PubMed CrossRef
- Kamat S, Ungar B, Agarwal A, et al. Innovation in development of dermatologic drugs approved by the US Food and Drug Administration between 2012 and 2022. JAMA Dermatol. 2024;160(2):226–229. PubMed CrossRef
- Clinical Research Trials. CenterWatch. Accessed May 1, 2025. https://www.centerwatch.com/clinical-trials/listings
- Biological Approvals by Year. FDA. Accessed May 1, 2025. https://www.fda.gov/vaccines-blood-biologics/development-approval-process-cber/biologicalapprovals-year
- Compilation of CDER New Molecular Entity (NME) Drug and New Biologic Approvals. FDA. Accessed May 1, 2025. https://www.fda.gov/drugs/drugapprovals-and-databases/compilation-cder-new-molecular-entity-nme-drugand-new-biologic-approvals
- Checklists - STROBE. Accessed September 9, 2024. https://www.strobestatement.org/checklists/
- Lanthier M, Miller KL, Nardinelli C, et al. An improved approach to measuring drug innovation finds steady rates of first-in-class pharmaceuticals, 1987-2011. Health Aff. 2013;32(8):1433–1439. PubMed CrossRef
- Guidances | Drugs. FDA. Accessed May 1, 2025. https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs
- Avis sur les médicaments. Accessed May 1, 2025. https://prescrire.org/medicaments-et-evaluations/avis-sur-les-medicaments
- Annual reports - Canada.ca. Accessed May 1, 2025. https://www.canada.ca/en/patented-medicine-prices-review/services/annual-reports.html
- Evaluation procedure - federal Joint Committee. Accessed May 1, 2025. https://www.g-ba.de/bewertungsverfahren/
- Haute Autorité de Santé - La HAS - home. Accessed May 1, 2025. https://www.has-sante.fr/jcms/pprd_2986129/en/home
- Haute Autorité de Santé - LATUDA (lurasidone), oral antipsychotic. Accessed May 1, 2025. https://www.has-sante.fr/jcms/c_1792838/en/latuda-lurasidone-oralantipsychotic
- Haute Autorité de Santé - ABILIFY MAINTENA (aripiprazole) - traitement d’entretien de la schizophrénie. Accessed May 1, 2025. https://www.has-sante.fr/jcms/p_3361550/en/abilify-maintena-aripiprazole-traitement-d-entretien-de-laschizophrenie
- Hyman SE. Revolution stalled. Sci Transl Med. 2012;4(155):155cm11. PubMed CrossRef
- Chen EY, Raghunathan V, Prasad V. An overview of cancer drugs approved by the US Food and Drug Administration based on the surrogate end point of response rate. JAMA Intern Med. 2019;179(7):915–921. PubMed CrossRef
- Miller AH, Raison CL. Burning down the house: reinventing drug discovery in psychiatry for the development of targeted therapies. Mol Psychiatry. 2023;28(1):68–75. PubMed CrossRef
- Ljungqvist I, Topor A, Forssell H, et al. Money and mental illness: a study of the relationship between poverty and serious psychological problems. Community Ment Health J. 2016;52(7):842–850. PubMed CrossRef
- Krainc D, Martin WJ, Casey B, et al. Shifting the trajectory of therapeutic development for neurological and psychiatric disorders. Sci Transl Med. 2023;15(720):eadg4775. PubMed CrossRef
- Hyman SE. Psychiatric drug development: diagnosing a crisis. Cerebrum. 2013;2013:5. PubMed
- Lenze E, Torous J, Arean P. Digital and precision clinical trials: innovations for testing mental health medications, devices, and psychosocial treatments. Neuropsychopharmacology. 2024;49(1):205–214. PubMed CrossRef
- Szerman N, Peris L. Precision psychiatry and dual disorders. J Dual Diagn. 2018;14(4):237–246. PubMed CrossRef
- Rief W. Moving from tradition-based to competence-based psychotherapy. Evid Based Ment Health. 2021;24(3):115–120. PubMed CrossRef
- Ahad AA, Sanchez-Gonzalez M, Junquera P. Understanding and addressing mental health stigma across cultures for improving psychiatric care: a narrative review. Cureus. 2023;15(5):e39549. PubMed CrossRef
- Mental illness - National Institute of Mental Health (NIMH). Accessed January 2, 2024. https://www.nimh.nih.gov/health/statistics/mental-illness
