Evidence map›Paper›PMID 36951997›Full record

ReviewNaunyn-Schmiedeberg's archives of pharmacology2023

A year in pharmacology: new drugs approved by the US Food and Drug Administration in 2022.

Gizem Kayki-Mutlu, Zinnet Sevval Aksoyalp, Leszek Wojnowski, Martin C Michel

Full text readReview
In one paragraph

Review in Naunyn-Schmiedeberg's archives of pharmacology, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 7 papers.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

7 citing papers in PubMed.

  1. Review
  2. Do GPCRs constitute the target of 30% of newly approved drugs in Germany?Naunyn-Schmiedeberg's archives of pharmacology · 2026
    Article
  3. Comparison of drug approvals of the FDA and EMA between 2013 and 2023.Naunyn-Schmiedeberg's archives of pharmacology · 2026
    Article
  4. Review
  5. Review
  6. Review
  7. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

4 authors.

Gizem Kayki-Mutlu *Department of Pharmacology, Faculty of Pharmacy, Ankara University, Ankara, Turkey.
Zinnet Sevval Aksoyalp *Department of Pharmacology, Faculty of Pharmacy, Izmir Katip Celebi University, Izmir, Turkey.
Leszek WojnowskiDepartment of Pharmacology, University Medical Center, Universitätsmedizin Mainz, Johannes Gutenberg University, Langenbeckstr. 1, 55118, Mainz, Germany.
Martin C MichelDepartment of Pharmacology, University Medical Center, Universitätsmedizin Mainz, Johannes Gutenberg University, Langenbeckstr. 1, 55118, Mainz, Germany. marmiche@uni-mainz.de.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

While new drug approvals by the U.S. Food and Drug Administration (FDA) had remained stable or even increased in the first 2 years of the COVID-19 pandemic, the 37 newly approved drugs in 2022 are considerably less than the 53 and 50 new drugs approved in 2020 and 2021, respectively, and less than the rolling 10-year average of 43. As in previous years of this annual review, we assign these new drugs to one of three levels of innovation: first drug against a condition ("first-in-indication"), first drug using a novel molecular mechanism ("first-in-class"), and "next-in-class," i.e., a drug using an already exploited molecular mechanism. We identify two "first-in-indication" (ganaxolon and teplizumab), 20 (54%) "first-in-class," and 17 (46%) "next-in-class" drugs. By treatment area, rare diseases and cancer drugs were once again the most prevalent (partly overlapping) therapeutic areas. Other continuing trends were the use of accelerated regulatory approval pathways and the reliance on biopharmaceuticals (biologics).

Indexed as

Biological ProductsCOVID-19Drug ApprovalHumansPandemicsPharmaceutical PreparationsUnited StatesUnited States Food and Drug AdministrationBiological ProductsPharmaceutical PreparationsFDAFirst-in-classNew drugsNext-in-class

Identifiers

PMID36951997
PMCPMC10034907

What OpenQuestion holds

Textfull text, public
LicenceCC BY
measurements read37
identifiers read1
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.