Pharmacological effects Clinical evaluation Production Method Patent cases
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Riociguat

Pharmacological effects Clinical evaluation Production Method Patent cases
Product Name
Riociguat
CAS No.
625115-55-1
Chemical Name
Riociguat
Synonyms
CS-718;Aratac;Riocguat;riocigua;Leosigua;Riociguat;Riociguatr;Bay 63-2521;Amiodaronum;Riociguat (250 mg)
CBNumber
CB62473752
Molecular Formula
C20H19FN8O2
Formula Weight
422.42
MOL File
625115-55-1.mol
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Riociguat Property

Melting point:
247-251°C (dec.)
Boiling point:
567.2±50.0 °C(Predicted)
Density 
1.51
storage temp. 
Refrigerator
solubility 
DMSO (Slightly, Heated), Methanol (Slightly, Heated)
pka
1.51±0.50(Predicted)
form 
Solid
color 
Off-White to Orange
InChI
InChI=1S/C20H19FN8O2/c1-28(20(30)31-2)15-16(22)25-18(26-17(15)23)14-12-7-5-9-24-19(12)29(27-14)10-11-6-3-4-8-13(11)21/h3-9H,10H2,1-2H3,(H4,22,23,25,26)
InChIKey
WXXSNCNJFUAIDG-UHFFFAOYSA-N
SMILES
C(OC)(=O)N(C1=C(N)N=C(C2C3=CC=CN=C3N(CC3=CC=CC=C3F)N=2)N=C1N)C
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Hazard and Precautionary Statements (GHS)

Symbol(GHS)
Signal word
Warning
Hazard statements

H302Harmful if swallowed

Precautionary statements

P264Wash hands thoroughly after handling.

P264Wash skin thouroughly after handling.

P270Do not eat, drink or smoke when using this product.

P301+P312IF SWALLOWED: call a POISON CENTER or doctor/physician IF you feel unwell.

P330Rinse mouth.

P501Dispose of contents/container to..…

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N-Bromosuccinimide Price

Cayman Chemical
Product number
9000554
Product name
Riociguat
Purity
≥98%
Packaging
5mg
Price
$85
Updated
2024/03/01
Cayman Chemical
Product number
9000554
Product name
Riociguat
Purity
≥98%
Packaging
10mg
Price
$158
Updated
2024/03/01
Cayman Chemical
Product number
9000554
Product name
Riociguat
Purity
≥98%
Packaging
25mg
Price
$352
Updated
2024/03/01
Cayman Chemical
Product number
9000554
Product name
Riociguat
Purity
≥98%
Packaging
50mg
Price
$521
Updated
2024/03/01
TRC
Product number
R520000
Product name
Riociguat
Packaging
10mg
Price
$150
Updated
2021/12/16
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Riociguat Chemical Properties,Usage,Production

Pharmacological effects

Riociguat is a soluble guanylyl cyclase activator, developed by the German Bayer ,it is an important signaling enzyme, which can be activated by nitric oxide (NO) to catalyze guanosine triphosphate ( GTP) to convert into the second messenger cyclic guanosine monophosphate (cGMP). Soluble guanylate cyclase is currently the only known NO receptor. Damage of NO-sGC-cGMP signal pathway is believed to be the cause of the incidence of cardiovascular, lung, endothelium, kidney and liver diseases. NO synthesis in patients with pulmonary hypertension is not enough, NO donor drugs, although effective, short half-life, riociguat can directly activate sGC, stable NO-sGC combination so as to upregulate the second messenger cGMP. riociquat can significantly increase exercise tolerance in patients with hemodynamic parameters of cardiac function and prolong the time to reach clinical worsening (PATENT study), It may also be effective in treating CTEPH(CHEST study) .
October 8, 2013, the US FDA approved Riociguat for the treatment of chronic thromboembolic pulmonary hypertension and PAH (Pulmonary Arterial Hypertension).
At present, Riociguat is not yet sold in the domestic market ,in the United States it is sold by the Haoeyou Pharmacy , the pharmacy is subsidiary of California Healthcom Group, because the market ofRiociguat is in its infancy, its sales grow slowly.

Clinical evaluation

In clinical trials ,261 patients with chronic thromboembolic pulmonary hypertension (CTEPH) were divided into riociguat and placebo groups, a six-minute walk distance (6MWD) as the main clinical endpoint, after 16 weeks of treatment, 6MWD of riociguat group increased by 46 meters higher than the average in the placebo group. 443 cases of PAH were divided into riociguat and placebo groups,after 12 weeks of treatment, riociguat group increased 36 meters higher than the average 6MWD in the placebo group. Boxed warning suggests that the drug has a embryo toxicity, pregnant patients are forbidden.
Adempas is granted baseing on two global III studies CHEST-1 and PATENT-1, whose findings are published in the July 25, 2013"New England Journal of Medicine," (2013; 369: 330-40; 2013; 369: 319-29). Thomson Reuters released analysis report that it is expected that sales of the drug in 2017 will reach $ 679 million, while the market will face a potential threat constituted by the Swiss company Actelion bosentan and Gilead drug Imber bosentan tablets.
The above information is edited by the chemicalbook of Tian Ye.

Production Method

Synthetic key of Riociguat is the synthesis of three heterocyclic ring. Compounds 1 and 2 directly close the pyrazole ring to generate 3,3 and 4 and then close the pyrazole ring to obtain5, ethyl of 5 is dehydrated using trifluoroacetic anhydride to give a cyano group after amidation by the ammonia , the cyano group is treated with methanol sodium and chloride ammonium to get amidine 6. The two nitrogen atoms on Amidine 6 as dinucleophile, with two cyano on compound 7 as the electrophile ,directly close the pyrimidine ring to give 8. pyrimidine 5-position amino group on 8 with a strong nucleophilic, directly reacts with methyl chloride and then methylates to give riociguat.

Figure 1 is a chemical reactions road map of Riociguat production .

Patent cases

US7173037 (there is a deadline to April 25, 2023), US6743798 (valid until July 16, 2019).

Description

In September 2013, Health Canada approved riociguat (also referred to as BAY 63-2521), for the treatment of patients with chronic thromboembolic pulmonary hypertension (CTEPH) after surgical treatment or inoperable CTEPH and for the treatment of adults with pulmonary arterial hypertension (PAH). Riociguat has a dual mode of action and works by (a) sensitizing sGC to the body’s NO by stabilizing NO–sGC binding and (b) an NO-independent, direct stimulation of sGC via a different binding site. This process restores the NO–sGC–cGMP pathway and leads to increased generation of cGMP with subsequent vasodilation.
Headache, dizziness, dyspepsia/gastritis, nausea, diarrhea, hypotension, vomiting, anemia, gastroesophageal reflux, and constipation were the most common adverse events ( 3%) observed during riociguat clinical trials. Riociguat comes with a black box warning for embryo-fetal toxicity.

Chemical Properties

Brownish Orange Solid

Originator

Bayer (Germany)

Uses

Riociguat is used in the treatment for pulmonary hypertension.

Uses

Riocguat is used in the treatment for pulmonary hypertension.

Definition

ChEBI: A carbamate ester that is the methyl ester of {4,6-diamino-2-[1-(2-fluorobenzyl)-1H-pyrazolo[3,4-b]pyridin-3-yl]pyrimidin-5-yl}methylcarbamic acid. It is used for treatment of chronic thromboembolic pulmonary hypertension an pulmonary arterial hypertension

brand name

Adempas

Clinical Use

Guanylate cyclase stimulator:
Treatment of chronic thromboembolic pulmonary hypertension (CTEPH) and pulmonary arterial hypertension (PAH)

Synthesis

The sequence began with condensation of commercial 2-fluorobenzylhydrazine (136) with sodium ethyl cyanopyruvate (137), which derives from diethyl oxalate to generate aminopyrazole 138. This was followed by the cyclocondensation with 3-dimethylaminoacrolein (139) to access pyrazolopyridine 140 in 50% yield for the two-step operation. Next, ester 140 was transformed to the corresponding primary amide 141, which was subsequently dehydrated upon treatment with trifluoroacetic acid anhydride (TFAA) to construct nitrile 142 in quantitative yield from 140. Subjection of cyanopyrazole 142 to Pinner conditions using methoxide and ammonium chloride in refluxing acetic acid generated amidine 143, and this was followed by condensation with the malononitrile derivative 144 in base to provide pyrimidine 145 in 73% yield. Hydrogenative cleavage of the phenyldiazine converted 145 to the pyrimidyl triamine 146, which underwent carbamoylation at the 40 position to produce the penultimate carbamate 147. This carbamate was then selectively methylated through deprotonation of the carbamate N¨CH proton followed by quench with methyl iodide. Sequential recrystallization from warm DMSO and refluxing ethyl acetate produced riociguat (XIX) in 64% yield from 147.

Drug interactions

Potentially hazardous interactions with other drugs
Avanafil, sildenafil, tadalafil, vardenafil: enhanced hypotensive effect - avoid.
Nicorandil: possibly enhanced hypotensive effect - avoid.
Nitrates: possibly enhanced hypotensive effect - avoid.

Metabolism

N-demethylation, catalysed by CYP1A1, CYP3A4, CYP2C8 and CYP2J2 is the major biotransformation pathway leading to its major circulating active metabolite M-1 (pharmacological activity: 1/10th to 1/3rd of riociguat) which is further metabolised to the pharmacologically inactive N-glucuronide.
Riociguat and metabolites are excreted via both renal (33-45%) and biliary/faecal routes (48-59%). Approximately 9-44% of the administered dose was found as unchanged riociguat in faeces.

Riociguat Preparation Products And Raw materials

Raw materials

Preparation Products

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Riociguat Suppliers

Suzhou Zehou Biotechnology Co. , Ltd.
Tel
0512-68716880 19984816880
Fax
18075373931
Email
sales@growingchem.com
Country
China
ProdList
195
Advantage
64
Hubei widely chemical technology Co., Ltd.
Tel
027-83778895 18602735115
Fax
027-51119224
Email
18602735115@163.com
Country
China
ProdList
1999
Advantage
64
Hefei Leaf Biotech Co.,Ltd.
Tel
055162628115 18155185130
Fax
+86-551-62628115
Email
3466118576@qq.com
Country
China
ProdList
15
Advantage
58
WuHu Linze pharmaceutical Co.,Ltd.
Tel
0553-0553-5802116 18356571950
Fax
-
Email
2592492800@qq.com
Country
China
ProdList
53
Advantage
58
Nanjing JiuSiNuo Biopharmaceutical Technology Co., Ltd
Tel
18851976882
Email
chensheng870628@126.com
Country
China
ProdList
59
Advantage
58
MIDECO
Tel
023-68625073 15723208759
Email
lidaijun@midecopharm.com
Country
China
ProdList
68
Advantage
58
ANHUI JINGKE BIOTECHNOLOGY CO.,LTD
Tel
0551-65206518 18133676923
Email
taozz@kingobiotech.com
Country
China
ProdList
89
Advantage
58
Jinan XinKe Pharmaceutical Technology Co., Ltd.
Tel
0531-88259693 17854196142
Fax
0531-88259693
Email
2820602043@qq.com
Country
China
ProdList
100
Advantage
58
Shanghai Boyle Chemical Co., Ltd.
Tel
Fax
86-21-57758967
Email
sales@boylechem.com
Country
China
ProdList
2922
Advantage
55
J & K SCIENTIFIC LTD.
Tel
010-82848833 400-666-7788
Fax
86-10-82849933
Email
jkinfo@jkchemical.com
Country
China
ProdList
96815
Advantage
76
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View Lastest Price from Riociguat manufacturers

BEIJING SJAR TECHNOLOGY DEVELOPMENT CO., LTD.
Product
Riociguat 625115-55-1
Price
US $0.00/g
Min. Order
1g
Purity
More Than 99%
Supply Ability
100kg/Month
Release date
2024-10-11
Zison Pharmaceutical (Shandong) Co., Ltd.
Product
Riociguat 625115-55-1
Price
US $0.00/kg
Min. Order
1kg
Purity
98%
Supply Ability
100kgs
Release date
2024-12-19
WUHAN FORTUNA CHEMICAL CO., LTD
Product
Riociguat 625115-55-1
Price
US $0.00-0.00/g
Min. Order
1g
Purity
98.0%
Supply Ability
10kg/month
Release date
2024-06-05

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