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Drug

Paliperidone palmitate

Approved · EMA
ClassSerotonin 2a (5-HT2a) receptor antagonistEmerging researchLate-stage development

Also known as Erzofri, Invega.

1
Research papers
2
Active clinical trials
2
Protein targets
4
Regulatory events
Latest activity
beta

Recent clinical, regulatory, research and industry developments relating to this drug.

Approval: Niapelf (EMA)

Regulatory2024-03-31EMA

European Long-acting Antipsychotics in Schizophrenia Trial

Clinical trial2020-08-26Completed · ClinicalTrials.gov

Approval: Xeplion (EMA)

Regulatory2011-03-04EMA

Profile

Identifiers & mechanism

Canonical identifiers, marketed brand names and mechanism, resolved across RxNorm, ChEMBL and ATC.

Canonical name
Paliperidone palmitate
Aliases & brands
ErzofriInvega
RxNorm CUI
858045
ChEMBL ID
CHEMBL2107360
UNII
R8P8USM8FR
Primary mechanism
Serotonin 2a (5-HT2a) receptor antagonist
Regulatory jurisdictions
ema

Pharmacology & targets

2 targets

Known molecular targets and mechanisms supported by curated pharmacology databases.

ANTAGONISTSerotonin 2a (5-HT2a) receptor antagonist
ANTAGONISTDopamine D2 receptor antagonist

Regulatory timeline

4 events

The complete regulatory record, grouped by authority — approvals, safety advisories and label changes. Each authority shows its most recent events; expand one to read its full history.

Earliest approval
2011-03-04
Latest approval
2024-03-31
Authorities
EMA
Total events
4
emaEuropean Medicines Agency· 4 events
2024-03-31Approval
Approval: Niapelf (EMA)
Indication: indicated for maintenance treatment of schizophrenia in adult patients stabilised withpaliperidone or risperidone. In selected adult patients with schizophrenia and previousShow full indication

indicated for maintenance treatment of schizophrenia in adult patients stabilised withpaliperidone or risperidone. In selected adult patients with schizophrenia and previous responsiveness to oral paliperidone or risperidone, Niapelf may be used without prior stabilisation with oral treatment if psychotic symptoms are mild to moderate and a long-acting injectable treatment is needed. 

Evidence ↗
2020-06-18Approval
Approval: Byannli (previously Paliperidone Janssen-Cilag International) (EMA)
Indication: Byannli (previously Paliperidone Janssen-Cilag International) a 6 monthly injection, is indicated for the maintenance treatment of schizophrenia in adult patients who areShow full indication

Byannli (previously Paliperidone Janssen-Cilag International) a 6 monthly injection, is indicated for the maintenance treatment of schizophrenia in adult patients who are clinically stable on 1 monthly or 3 monthly paliperidone palmitate injectable products (see section 5.1).

Evidence ↗
2014-12-05Approval
Approval: Trevicta (previously Paliperidone Janssen) (EMA)
Indication: Trevicta, a 3 monthly injection, is indicated for the maintenance treatment of schizophrenia in adult patients who are clinically stable on 1 monthly paliperidone palmitateShow full indication

Trevicta, a 3 monthly injection, is indicated for the maintenance treatment of schizophrenia in adult patients who are clinically stable on 1 monthly paliperidone palmitate injectable product.

Evidence ↗

Contains information from the European Medicines Agency (European Medicines Agency), © EMA, reused under CC BY 4.0.

Clinical trials

37 trials

The current development programme across all trial phases — status mix, phase distribution and the late-stage studies shaping the evidence base.

Development programme
CLINICALTRIALS.GOV · LIVE REGISTRY
37
registered trials across all phases
LATEST COMPLETION 2024
2
Active studies
2
Recruiting
33
Late-stage (III+)
31
Completed
4
Discontinued
PHASE DISTRIBUTIONn = 37
Phase 13Phase 21Phase 317Phase 414Phase N / A2

Late-stage studies

Phase III+ trials still open or recently active — where late-stage evidence is being generated.

Recent completions

Trials that read out recently, adding to the completed evidence base.

Research activity

1 papers

Key research shaping understanding of this drug, combining the latest publications with the most influential evidence.

Most influential
Recent papers
Major research themes2
Antipsychotic Agents1Mental Disorders1
Journals, researchers & institutions
Top journals
  • Journal of child and adolescent psychopharmacology1
Leading researchers
  • Clark C1
  • Fabian T1
  • Goulding H1
  • Sun C1
  • Temelie A1
  • Yabs M1
Leading institutions
free-text, unnormalised
  • University of Pittsburgh School of Pharmacy1
  • UPMC Western Psychiatric Hospital1

Related drugs

1 matches

Drugs sharing diseases, protein targets and literature with this one. Ranked by graph evidence (shared targets + diseases weighted above co-mentions).

Acts on the same molecular target as Paliperidone palmitate, with an overlapping disease area.

2 shared targets1 shared disease1 shared paper
References & data sources
  • RxNorm (U.S. National Library of Medicine) — drug identity
  • ChEMBL (EMBL-EBI) & UniProt — pharmacology and targets
  • Europe PMC — research literature
  • ClinicalTrials.gov — clinical trials
  • Regulatory event sources are credited in the Regulatory Timeline above.