Palovarotene Clinical Trials

Size	Price	Qty
5mg	USD 147
25mg	USD 370

Clinical Trials

Multiple clinical trials sponsored by industry leaders, including Clementia Pharmaceuticals and Ipsen, evaluate palovarotene across Phase 1 through Phase 3 studies as well as observational registries. Research focuses on rare skeletal conditions like Fibrodysplasia Ossificans Progressiva and Multiple Hereditary Exostoses, alongside evaluations in Dry Eye Disease, hepatic impairment, and healthy volunteers. Across this clinical landscape, recruitment statuses encompass completed, recruiting, terminated, and not yet recruiting trials.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT06908954	COMPLETED	Hepatic Impairment; Healthy	Ipsen	2025-03-14	PHASE1
NCT05027802	COMPLETED	Fibrodysplasia Ossificans Progressiva (FOP)	Ipsen	2022-03-14	PHASE3
NCT06089616	Not yet recruiting	Fibrodysplasia Ossificans Progressiva	Ipsen	2024-04-15	--
NCT02279095	COMPLETED	Fibrodysplasia Ossificans Progressiva	Clementia Pharmaceuticals Inc.	2014-10-09	PHASE2
NCT03442985	TERMINATED	Exostoses, Multiple Hereditary	Clementia Pharmaceuticals Inc.	2018-03-22	PHASE2
NCT03312634	COMPLETED	Fibrodysplasia Ossificans Progressiva	Clementia Pharmaceuticals Inc.	2017-11-30	PHASE3
NCT04829773	COMPLETED	Fibrodysplasia Ossificans Progressiva	Clementia Pharmaceuticals Inc.	2019-01-03	PHASE1
NCT04762355	COMPLETED	Dry Eye Disease	Clementia Pharmaceuticals Inc.	2018-08-30	PHASE1
NCT02521792	TERMINATED	Fibrodysplasia Ossificans Progressiva	Clementia Pharmaceuticals Inc.	2015-12-07	PHASE2
NCT02190747	COMPLETED	Fibrodysplasia Ossificans Progressiva	Clementia Pharmaceuticals Inc.	2014-07-14	PHASE2
NCT04829786	COMPLETED	FOP	Clementia Pharmaceuticals Inc.	2015-09-01	PHASE1
NCT02190747	Completed	Fibrodysplasia Ossificans Progressiva	Clementia Pharmaceuticals Inc.\|Ipsen	2014-07-14	Phase 2

(data from https://clinicaltrials.gov, updated on 2026-04-30)

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Palovarotene functions as a selective agonist of nuclear retinoic acid receptor gamma (RAR-γ), binding the receptor to repress downstream bone morphogenetic protein signaling and attenuate osteogenic gene expression. This cellular suppression of chondrocyte differentiation inhibits heterotopic ossification, directly addressing the underlying pathophysiological bone formation in conditions such as Fibrodysplasia Ossificans Progressiva.

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>).