drugset

Drugs / PP6M

Follow last change Aug 2023 re-read 3 minutes ago

PP6M

also known as PP6M injection Dose 1

Developed for: schizophrenia
Investigated by: Janssen Research & Development, LLC

Regulatory milestones approvals, filings & regulatory actions · 1 recorded

Milestone	Jurisdiction	Brand	Indication	Date	Sentence it was read from
Filed	US (FDA)	—	schizophrenia	2020-11-02	“Janssen Submits Paliperidone Palmitate 6-Month (PP6M) Supplemental New Drug Application to U.S. FDA for Treatment of Schizophrenia in Adults” jnj.com ↗

Trials 1

today NCT04072575 · Ph 3

2020202120222023202420252026

Phase	Registry id	Dates	Indication	Sponsor	Status	Outcome
Phase 3	NCT04072575	Sep 2019 → May 2022	schizophrenia	Janssen Research & Development, LLC	Completed	Met primary

News releases announcing trial results or a regulatory action · 4

Date	Issuer	Release
2021-11-23	Janssen Research & Development, LLC	Regulatory European Commission Approves BYANNLI® (6-monthly Paliperidone Palmitate; PP6M) for the Maintenance Treatment of Schizophrenia in Adults jnj.com ↗
2021-09-17	Janssen Research & Development, LLC	Regulatory Janssen Receives Positive CHMP Opinion for BYANNLI® (6-monthly Paliperidone Palmitate) for the Maintenance Treatment of Schizophrenia in Adults jnj.com ↗
2020-12-04	Janssen Research & Development, LLC	Regulatory Janssen Submits Marketing Authorisation Extension to the European Medicines Agency to Register Paliperidone Palmitate 6-Monthly (PP6M) for Treatment of Schizophrenia in Adults jnj.com ↗
2020-11-02	Janssen Research & Development, LLC	Regulatory Janssen Submits Paliperidone Palmitate 6-Month (PP6M) Supplemental New Drug Application to U.S. FDA for Treatment of Schizophrenia in Adults jnj.com ↗ Janssen Pharmaceutical Companies of Johnson & Johnson (Janssen) today announced the submission of a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) for paliperidone palmitate 6-month (PP6M) for the treatment of adults diagnosed with schizophrenia.

All press releases naming this drug 4 releases

Date	Issuer	Release
2021-11-23	Janssen Research & Development, LLC	European Commission Approves BYANNLI® (6-monthly Paliperidone Palmitate; PP6M) for the Maintenance Treatment of Schizophrenia in Adults jnj.com ↗
2021-09-17	Janssen Research & Development, LLC	Janssen Receives Positive CHMP Opinion for BYANNLI® (6-monthly Paliperidone Palmitate) for the Maintenance Treatment of Schizophrenia in Adults jnj.com ↗
2020-12-04	Janssen Research & Development, LLC	Janssen Submits Marketing Authorisation Extension to the European Medicines Agency to Register Paliperidone Palmitate 6-Monthly (PP6M) for Treatment of Schizophrenia in Adults jnj.com ↗
2020-11-02	Janssen Research & Development, LLC	Janssen Submits Paliperidone Palmitate 6-Month (PP6M) Supplemental New Drug Application to U.S. FDA for Treatment of Schizophrenia in Adults jnj.com ↗

Evidence & citations 3 cited values

Every value below carries the sentence it was read from. 2 sources stand behind the page.

Field	Value	Cited text
Known as	PP6M	“Paliperidone palmitate 6-month (PP6M) demonstrated noninferiority to paliperidone palmitate 3-month in preventing relapse in patients with schizophrenia in a phase 3...” PMID 37480362 ↗ Aug 2023
Known as	PP6M injection Dose 1	ClinicalTrials.gov intervention name — accepted as the source's own label NCT04072575 ↗
Route	Intramuscular	“intramuscular (IM) injection” NCT04072575 ↗