NEVANIMIBE HYDROCHLORIDE

Investigational

Details

Stereochemistry	ACHIRAL
Molecular Formula	C27H39N3O.ClH
Molecular Weight	458.079
Optical Activity	NONE
Defined Stereocenters	0 / 0
E/Z Centers	0
Charge	0

SHOW SMILES / InChI

Structure Search

SMILES

Cl.CC(C)C1=CC=CC(C(C)C)=C1NC(=O)NCC2(CCCC2)C3=CC=C(C=C3)N(C)C

InChI

InChIKey=SDOOGTHIDFZUNM-UHFFFAOYSA-N

InChI=1S/C27H39N3O.ClH/c1-19(2)23-10-9-11-24(20(3)4)25(23)29-26(31)28-18-27(16-7-8-17-27)21-12-14-22(15-13-21)30(5)6;/h9-15,19-20H,7-8,16-18H2,1-6H3,(H2,28,29,31);1H

HIDE SMILES / InChI

Molecular Formula	ClH
Molecular Weight	36.461
Charge	0
Count

Stereochemistry	ACHIRAL
Additional Stereochemistry	No
Defined Stereocenters	0 / 0
E/Z Centers	0
Optical Activity	NONE

Molecular Formula	C27H39N3O
Molecular Weight	421.6181
Charge	0
Count

Stereochemistry	ACHIRAL
Additional Stereochemistry	No
Defined Stereocenters	0 / 0
E/Z Centers	0
Optical Activity	NONE

Description
Sources: https://www.ncbi.nlm.nih.gov/pubmed/7899779 | https://clinicaltrials.gov/ct2/show/NCT03669549 | https://www.millendo.com/our-programs/nevanimibe.php

Nevanimibe (also known as PD-132301 and ATR101) is an acetyl-CoA C-acyltransferase (ACAT1) inhibitor. Millendo Therapeutics is currently advancing the development of nevanimibe for the treatment of two orphan adrenal diseases: classic congenital adrenal hyperplasia (CAH) and endogenous Cushing's syndrome (CS). Both of these diseases are associated with an overactive adrenal cortex causing excess steroid production. Millendo believes that nevanimibe represents an adrenal-specific approach that will address these diseases through the reduction of adrenal steroid production. Millendo is currently conducting Phase 2 clinical trial to assess the safety and efficacy of nevanimibe in subjects with endogenous Cushing’s syndrome and for the treatment of adult CAH.

Originator

Approval Year

C_max

Value	Dose	Co-administered	Analyte	Population
1262 ng/mL EXPERIMENT https://pubmed.ncbi.nlm.nih.gov/32589738/	1000 mg 2 times / day multiple, oral dose: 1000 mg route of administration: Oral experiment type: MULTIPLE co-administered:		NEVANIMIBE HYDROCHLORIDE plasma	Homo sapiens population: UNHEALTHY age: ADULT sex: FEMALE / MALE food status: FED

AUC

Value	Dose	Co-administered	Analyte	Population
3066 ng × h/mL EXPERIMENT https://pubmed.ncbi.nlm.nih.gov/32589738/	1000 mg 2 times / day multiple, oral dose: 1000 mg route of administration: Oral experiment type: MULTIPLE co-administered:		NEVANIMIBE HYDROCHLORIDE plasma	Homo sapiens population: UNHEALTHY age: ADULT sex: FEMALE / MALE food status: FED

T_1/2

Value	Dose	Co-administered	Analyte	Population
10 h EXPERIMENT https://pubmed.ncbi.nlm.nih.gov/32589738/	1000 mg 2 times / day multiple, oral dose: 1000 mg route of administration: Oral experiment type: MULTIPLE co-administered:		NEVANIMIBE HYDROCHLORIDE plasma	Homo sapiens population: UNHEALTHY age: ADULT sex: FEMALE / MALE food status: FED

PubMed

Title	Date	PubMed
Biochemical alterations in guinea pig adrenal cortex following administration of PD 132301-2, an inhibitor of acyl-CoA:cholesterol acyltransferase.	1995-02-17	9001442
Toxicologic effects of a novel acyl-CoA:cholesterol acyltransferase inhibitor in cynomolgus monkeys.	1994-09-01	7899779
Subacute toxicity of a novel inhibitor of acyl-CoA: cholesterol acyltransferase in beagle dogs.	1993-02	8383621
Morphogenesis of a zone-specific adrenocortical cytotoxicity in guinea pigs administered PD 132301-2, an inhibitor of acyl-CoA:cholesterol acyltransferase.	1993	8397438

Sample Use Guides

In Vivo Use Guide

During the 12-week treatment period, all subjects will begin dosing with nevanimibe HCl (PD-132301) 1000 mg BID and be dose titrated to 1500 mg BID and then 2000 mg BID based upon the 17-OHP response that will be assessed every 4 weeks.

Route of Administration: Oral

Substance Class	Chemical Created by `admin` on `Mon Mar 31 21:10:25 GMT 2025` Edited by `admin` on `Mon Mar 31 21:10:25 GMT 2025`
Record UNII	TK694ZFS57
Record Status	`Validated (UNII)`
Record Version

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Name

Type

Language

NEVANIMIBE HYDROCHLORIDE

Official Name

English

PD-132301 HYDROCHLORIDE

Preferred Name

English

PD-132301-02

Code

English

PD132301-2

Code

English

ATR-101 HYDROCHLORIDE

Code

English

PD-132301-2

Code

English

PD 132301-02

Code

English

NEVANIMIBE HYDROCHLORIDE [USAN]

Common Name

English

UREA, N-(2,6-BIS(1-METHYLETHYL)PHENYL)-N'-((1-(4-(DIMETHYLAMINO)PHENYL)CYCLOPENTYL)METHYL)-, HYDROCHLORIDE (1:1)

Systematic Name

English

N-(2,6-BIS(PROPAN-2-YL)PHENYL)-N'-((1-(4-(DIMETHYLAMINO)PHENYL) CYCLOPENTYL)METHYL)UREA HYDROCHLORIDE

Systematic Name

English

ATR-101

Code

English

Classification Tree Code System Code

FDA ORPHAN DRUG

364712