Evidence map›Paper›PMID 40372131›Full record

ReviewPharmaceutical patent analyst2024

Proteolysis targeting chimeras (PROTACs) in oncology: a review of patents and regulatory considerations.

Sowndharya M, Ramesh Joga, Kajal Gandhi, Sravani Yerram, Rajeev Singh Raghuvanshi, Saurabh Srivastava

Abstract readReview
In one paragraph

Review in Pharmaceutical patent analyst, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing 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

3 citing papers in PubMed.

  1. Article
  2. Review
  3. Review
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

6 authors.

Sowndharya MDepartment of Regulatory Affairs, National Institute of Pharmaceutical Education and Research, India.
Ramesh JogaDepartment of Regulatory Affairs, National Institute of Pharmaceutical Education and Research, India.
Kajal GandhiDepartment of Regulatory Affairs, National Institute of Pharmaceutical Education and Research, India.
Sravani YerramDepartment of Regulatory Affairs, National Institute of Pharmaceutical Education and Research, India.
Rajeev Singh RaghuvanshiCentral Drug Standard Control Organization (CDSCO), Directorate General of Health Services, Ministry of Health & Family Welfare, Government of India, New Delhi, India.
Saurabh SrivastavaDepartment of Regulatory Affairs, National Institute of Pharmaceutical Education and Research, India.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionProteolysis Targeting Chimeras (PROTACs) represents a groundbreaking advancement in drug discovery and targeted protein degradation. Unlike traditional small-molecule inhibitors, PROTACs leverage the cell's natural protein degradation machinery to selectively degrade pathogenic proteins, offering significant therapeutic potential for previously undruggable targets and complex diseases such as cancer and neurodegenerative disorders. Understanding the regulatory landscape governing their approval is crucial as their development accelerates. AREAS COVERED: This review provides an overview of recent patents, regulatory considerations, emerging concerns, and future perspectives of PROTACs in cancer management. EXPERT OPINION: From a regulatory perspective, PROTACs present unique challenges and opportunities. Their dual-functional nature requires a nuanced approach to classification and approval, blending small-molecule and biologic regulatory frameworks. Specific guidelines addressing pharmacokinetic and pharmacodynamic profiles are needed. Comprehensive preclinical evaluation and robust clinical trial designs are essential to manage off-target effects and immunogenic responses. The collaboration between regulatory bodies, academia, and industry is crucial for establishing a clear pathway for PROTAC approval. Future considerations must account for advancements in PROTAC technology to ensure safe and effective therapies reach patients. While PROTACs hold immense promise, their regulatory journey requires tailored guidelines and rigorous evaluation to realize their full potential.

Indexed as

Antineoplastic AgentsNeoplasmsProteolysisAnimalsDrug ApprovalDrug DiscoveryHumansPatents as TopicProteolysis Targeting ChimeraAntineoplastic AgentsProteolysis Targeting ChimeraCanceremerging strategiesprogressPROTACsrecent patentsregulatory considerationstargeted protein degradationubiquitin-proteasome system

Identifiers

PMID40372131
PMCPMC12367099

What OpenQuestion holds

Textmetadata
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.