Frequently Asked Questions

From January 1, 2012, to December 31, 2024, the study identified 21 new approved psychiatric drugs and 1 new supplemental indication, and 7 of the 22 approvals or indications (31.8%) were categorized as first-in-class. The remaining approvals were classified as 13 addition-to-class drugs (59.1%) and 2 advance-in-class drugs (9.1%), meaning more than 65% showed a comparatively low degree of innovation by the study's primary FDA-based measure.

No. Only 2 of the 20 new approved drugs or supplemental indications with available external benefit assessments were rated as having high added therapeutic benefit. Those 2 were aripiprazole for Tourette disorder and lurasidone for major depressive episodes in bipolar I disorder, both according to the French National Authority for Health. All other drugs were either not rated or were rated as having low added therapeutic benefit by the external organizations the authors examined.

Expedited FDA pathways were uncommon: 4 of 22 approvals or indications (18.2%) received expedited FDA approval, and 3 (13.6%) were designated as breakthrough drugs. The authors present this as one indicator that unusually high-impact psychiatric drug approvals were relatively infrequent during the study period.

Yes. Three of the 22 approvals or indications (13.6%) were combinations or reformulations of existing drugs. The study excluded simple reformulations and combinations made exclusively of previously approved drugs from its main inclusion criteria, but among the identified approvals, the authors still found that a notable share represented combinations or reformulations rather than clearly novel therapies.

Approvals were concentrated in mood and psychotic disorders. Of the 22 approvals or indications, 11 (50.0%) were for mood disorders, 6 (27.3%) were for schizophrenia or other psychotic disorders, 2 (9.1%) were for attention-deficit/hyperactivity disorder, 3 (13.6%) were for sleep-related disorders, and 3 (13.6%) were for other disorders. The total exceeds 22 because some drugs had multiple approvals.

The study found that psychiatric drug innovation lagged behind both dermatology and oncology. Over 20122022, dermatology had 78 FDA-approved therapies or supplemental indications, nearly 4 times the psychiatric total in this similar period, and about 46% of dermatologic drugs were considered innovative versus 32% of psychiatric drugs by the same metric. In oncology, a cited study found that 60% of 85 approved oncologic drugs from 2006 to 2018 were innovative, compared with 31.8% first-in-class psychiatric approvals in the present analysis.

The study's primary measure of innovation was the FDA-based classification of each approval as first-in-class, advance-in-class, or addition-to-class. The authors defined first-in-class drugs as new molecular entities used for a novel indication or with a novel putative mechanism of action. They defined addition-to-class as new molecular entities for an already covered indication or with a similar mechanism of action to existing drugs that received priority review during the study period, and advance-in-class as drugs for an already covered indication or with a similar mechanism that did not warrant priority review during the study period.

The authors suggest several possible reasons, not definitive causes. They note the comparative absence of clear biomarkers in psychiatry, which may limit target selection, prognostication, and translation of early-phase findings into later-phase success. They also suggest that market saturation with off-patent and relatively inexpensive existing medications may make it harder for another addition-to-class psychiatric drug to show enough advantage to succeed.

The study evaluated approved products only and did not capture all forms of innovation in psychiatric care. The authors note that it excluded developments after the end of 2024, did not reflect pending approvals such as psychedelics, and did not include innovation in combination regimens, delivery vehicles, or augmentation strategies. They also state that the analysis does not measure innovation occurring in earlier development phases or downstream advances in care precision, quality, and access.

Not necessarily. In this analysis, only 7 of 22 psychiatric approvals or indications (31.8%) were first-in-class, only 4 (18.2%) received expedited FDA approval, and only 2 had a high added therapeutic benefit rating from an external agency. The authors therefore conclude that many recently approved psychiatric drugs represented limited innovation or modest added benefit rather than major breakthroughs.