Evidence map›Paper›PMID 35543739›Full record

ReviewNaunyn-Schmiedeberg's archives of pharmacology2022

A year in pharmacology: new drugs approved by the US Food and Drug Administration in 2021.

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

Erratum issuedOpen access · hybridAbstract readReview
In one paragraph

Review in Naunyn-Schmiedeberg's archives of pharmacology, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. Cited by 14 papers.

0numbers the graph read from it
0cells of the map it votes in
14citing papers in PubMed
5.7field-weighted citation impact, top 4% of its field
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

14 citing papers in PubMed, 21 citations in OpenAlex.

  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. Article
  6. Review
  7. Article
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  13. Review
  14. Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

4 authors at 3 institutions in 2 countries.

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, Johannes Gutenberg University, Langenbeckstr. 1, 55118, Mainz, Germany.
Martin C MichelDepartment of Pharmacology, University Medical Center, Johannes Gutenberg University, Langenbeckstr. 1, 55118, Mainz, Germany. marmiche@uni-mainz.de.
Johannes Gutenberg University Mainz · DEAnkara University · TRIzmir Kâtip Çelebi University · TR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

The second year of the COVID-19 pandemic had no adverse effect on the number of new drug approvals by the US Food and Drug Administration (FDA). Quite the contrary, with a total of 50 new drugs, 2021 belongs to the most successful FDA years. We assign these new drugs to one of three levels of innovation: (1) first drug against a condition ("first-in-indication"), (2) first drug using a novel molecular mechanism ("first-in-class"), and (3) "next-in-class", i.e., a drug using an already exploited molecular mechanism. We identify 21 first-in-class, 28 next-in-class, and only one first-in-indication drugs. By treatment area, the largest group is once again cancer drugs, many of which target specific genetic alterations. Every second drug approved in 2021 targets an orphan disease, half of them being cancers. Small molecules continue to dominate new drug approvals, followed by antibodies and non-antibody biopharmaceuticals. In 2021, the FDA continued to approve drugs without strong evidence of clinical effects, best exemplified by the aducanumab controversy.

Indexed as

COVID-19 Drug TreatmentDrug-Related Side Effects and Adverse ReactionsDrug ApprovalHumansPandemicsUnited StatesUnited States Food and Drug AdministrationFDAFirst-in-classFirst-in-indicationNew drugsNext-in-class

Identifiers

PMID35543739
PMCPMC9091141
OpenAlexW4280510143

What Socratic holds

Textmetadata
LicenceCC BY
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 Socratic graph.