Lotamilast (RVT-501) Clinical Trials

Size	Price	Qty
5mg	USD 487

Clinical Trials

Multiple clinical trials sponsored by industry entities, such as Dermavant Sciences, evaluate topical formulations of Lotamilast (RVT-501) primarily for the treatment of atopic dermatitis. Spanning Phase 1, Phase 2, and Phase 1/Phase 2 evaluations, these studies comprise both completed trials and those with an unknown recruitment status. They focus on assessing the drug's safety, tolerability, pharmacokinetics, and therapeutic efficacy in affected patient populations, including pediatric groups.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT03415282	Unknown status	Atopic Dermatitis	Dermavant Sciences GmbH\|Dermavant Sciences Inc.	2018-02-05	Phase 1
NCT03394677	Completed	Atopic Dermatitis	Dermavant Sciences GmbH\|Dermavant Sciences Inc.	2018-01-25	Phase 2
NCT02094235	Completed	Atopic Dermatitis	Dermavant Sciences GmbH\|Dermavant Sciences Inc.	2014-01	Phase 1\|Phase 2

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

Check the Lotamilast (RVT-501) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Lotamilast selectively inhibits phosphodiesterase 4 (PDE4) with an IC50 of 2.8 nM, preventing the hydrolysis of cyclic adenosine monophosphate (cAMP) and thereby enhancing intracellular cAMP signaling to suppress pro-inflammatory cytokine production in immune cells. This dampening of inflammatory pathways effectively mitigates localized cutaneous inflammation, providing direct therapeutic relevance for treating dermatological conditions such as atopic dermatitis studied in clinical trials.

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>).