Rilpivirine Hydrochloride Clinical Trials

Size	Price	Qty
5mg	USD 170

Clinical Trials

Multiple completed clinical trials evaluate Rilpivirine Hydrochloride (TMC278) across Phase 1 and Phase 4 studies involving healthy volunteers and individuals with HIV. Sponsored primarily by Janssen entities and Tibotec Pharmaceuticals Ireland in collaboration with Merck, these investigations assess the safety, pharmacokinetics, and drug-drug interactions of oral tablet and long-acting injectable formulations.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT01804244	Completed	Healthy	Janssen Pharmaceutical K.K.	2013-03	Phase 4
NCT01656018	Completed	Healthy	Janssen Research & Development LLC	2012-11	Phase 1
NCT01519128	Completed	Healthy	Janssen R&D Ireland	2012-01	Phase 1
NCT01288755	Completed	HIV Infections	Tibotec Pharmaceuticals Ireland\|Raltegravir is provided by Merck.	2011-02	Phase 1

(data from https://clinicaltrials.gov, updated on 2024-05-22)

Check the Rilpivirine Hydrochloride product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Rilpivirine Hydrochloride specifically binds to the allosteric non-nucleoside binding pocket of HIV-1 reverse transcriptase, inhibiting viral RNA-dependent DNA polymerase activity and halting early reverse transcription. By suppressing viral cDNA synthesis and subsequent viral replication within host immune cells, this therapeutic mechanism directly supports its clinical evaluation for managing HIV infections and optimizing pharmacokinetic profiles in human trial subjects.

Appendix RUO and cGMP Quality Standards

Quality Dimension	RUO (Research Use Only)	cGMP (Current Good Manufacturing Practice)
Clinical Applicability	Prohibited in human clinical trials or medical diagnostics.	Mandatory for human clinical trials (Phase I–III) and therapies.
Regulatory Status	Non-regulated grade; exempt from drug manufacturing laws.	Legally enforced by health authorities (e.g., FDA, EMA, NMPA).
Facility Environment	Unclassified analytical or research laboratories.	Validated Cleanrooms (ISO Class 5–8) with continuous monitoring.
Quality Control	Basic purity and activity testing.	Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma).
Process Validation	Basic equipment calibration; no process validation required.	Full qualification (IQ/OQ/PQ) and complete batch records.
Quality Assurance	Vendor self-declared without required formal QMS.	Mandatory QA/QC unit, Change Control, CAPA, and vendor audits.
Regulatory Impact	High risk of IND rejection if used as a critical raw material.	Required for IND/NDA filings, supported by Drug Master Files (DMF).

Footnotes

Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).