Delving into the Latest Updates on Ipratropium Bromide with Synapse

Overview

Basic Info

Drug Type

Small molecule drug

Synonyms

Ipratropium bromide (USP), Ipratropium Bromide Hydrate, Ipratropium bromide hydrate (JP17)

+ [8]

Target

mAChRs

Action

antagonists

Mechanism

mAChRs antagonists(Muscarinic acetylcholine receptor antagonists)

Therapeutic Areas

Immune System DiseasesInfectious DiseasesRespiratory Diseases

Active Indication

Pulmonary Disease, Chronic ObstructiveAsthmaBronchitis, Chronic+ [1]

Inactive Indication

Bronchial SpasmCommon ColdDyspnea+ [2]

Originator Organization

Boehringer Ingelheim GmbH

Active Organization

Teijin Pharma Ltd.

China Resources Double-Crane Pharmaceutical Co., Ltd.Boehringer Ingelheim Pharma GmbH & Co., KG

+ [2]

Inactive Organization

Boehringer Ingelheim GmbHXindong Biotechnology Co., Ltd.

License Organization-

Drug Highest PhaseApproved

First Approval Date

Japan (25 Oct 1980),

AsthmaBronchitis, ChronicPulmonary Emphysema

Regulation-

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Structure/Sequence

Molecular FormulaC20H32BrNO4

InChIKeyKEWHKYJURDBRMN-ZEODDXGYSA-M

CAS Registry66985-17-9

主要研究目的：以山东达因海洋生物制药股份有限公司委托山东达因金控儿童制药有限公司生产的异丙托溴铵吸入气雾剂为受试制剂（20μg/揿），以Boehringer Ingelheim Pharma GmbH&Co.KG生产的异丙托溴铵吸入气雾剂（爱全乐®，20μg/揿）为参比制剂，评价中国健康研究参与者在非炭阻、空腹条件下经口吸入受试制剂与参比制剂后的生物等效性。次要研究目的：评价中国健康研究参与者在非炭阻、空腹条件下经口吸入受试制剂与参比制剂的安全性。

[Translation]

The main purpose of the study is to use the ipratropium bromide inhalation aerosol produced by Shandong Dayin Jinkong Children's Pharmaceutical Co., Ltd. commissioned by Shandong Dayin Marine Biopharmaceutical Co., Ltd. as the test preparation (20μg/press), and the ipratropium bromide inhalation aerosol (Aquanle®, 20μg/press) produced by Boehringer Ingelheim Pharma GmbH&Co.KG as the reference preparation, to evaluate the bioequivalence of the test preparation and the reference preparation after oral inhalation of the Chinese health study participants under non-charcoal barrier and fasting conditions. Secondary purpose of the study: to evaluate the safety of the test preparation and the reference preparation after oral inhalation of the Chinese health study participants under non-charcoal barrier and fasting conditions.

Start Date20 Jul 2025

Sponsor / Collaborator

Shandong Dayin Oceanic Biochemicals Co. Ltd.

CTR20250540

/ CompletedNot Applicable

异丙托溴铵吸入气雾剂人体生物等效性研究

[Translation] Study on the bioequivalence of ipratropium bromide inhalation aerosol in healthy volunteers

主要研究目的：研究健康受试者空腹经口吸入受试制剂异丙托溴铵吸入气雾剂（20 μg/揿×1揿）和参比制剂“Atrovent®”（20 μg/揿×1揿）的吸收程度和吸收速度的差异，评价空腹经口吸入异丙托溴铵吸入气雾剂的生物等效性。次要研究目的：研究受试制剂异丙托溴铵吸入气雾剂和参比制剂“Atrovent®”在健康受试者中的安全性。

[Translation]

The main purpose of the study is to study the difference in absorption degree and absorption rate of the test ipratropium bromide inhalation aerosol (20 μg/press×1 press) and the reference preparation "Atrovent®" (20 μg/press×1 press) by oral inhalation of the test preparation in healthy subjects on an empty stomach, and to evaluate the bioequivalence of ipratropium bromide inhalation aerosol by oral inhalation of the test preparation in healthy subjects on an empty stomach. The secondary purpose of the study is to study the safety of the test ipratropium bromide inhalation aerosol and the reference preparation "Atrovent®" in healthy subjects.

Start Date19 May 2025

Sponsor / Collaborator

Beijing Sihuan Kebao Pharmaceutical Co., Ltd.

CTIS2024-514065-19-00

/ RecruitingPhase 3IIT

PHASE III, DOUBLE-BLIND, RANDOMIZED, CONTROLLED, NON-INFERIORITY, PHASE III CLINICAL TRIAL TO EVALUATE THE EFFICACY OF SALBUTAMOL MONOTHERAPY COMPARED TO SALBUTAMOL PLUS IPRATROPIUM BROMIDE IN THE MANAGEMENT OF MODERATE ACUTE ASTHMATIC EXARCEBATIONS IN CHILDREN IN THE EMERGENCY DEPARTMENT

Start Date11 Apr 2025

Sponsor / Collaborator-

100 Clinical Results associated with Ipratropium Bromide

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100 Translational Medicine associated with Ipratropium Bromide

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100 Patents (Medical) associated with Ipratropium Bromide

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2,219

Literatures (Medical) associated with Ipratropium Bromide

01 Jul 2025·RESPIRATORY MEDICINE

Inhalers or nebulisation of salbutamol in childhood asthma exacerbations in emergency departments

Article

Author: Lopes, Anne-Aurélie ; Lemaçon, Clara

PURPOSE:

Asthma exacerbations often lead to paediatric emergency department (PED) visits, but evidence for paediatric management remains limited, and recommendations under discussion. This study compared salbutamol delivered via nebulisation and pressurised metered dose inhalers (pMDI) with a holding chamber in children with mild to severe asthma exacerbations.

METHODS:

A two-centre study was conducted during eight months, comparing hospitalisation rates, clinical improvement, side effects, and PED visit length in the overall population and in children under and over 6 years old.

RESULTS:

A total of 384 patients were included, primarily with mild and moderate exacerbations of similar severity between groups. The discharge rate was comparable between groups in the overall population (82.7 % without any nebulisation in the pMDI group versus 81.6 %, p = 0.93), but higher for children under 6 years old treated with pMDI (98.1 % versus 76.9 %, p < 0.001). The pMDI group exhibited significantly lower hospitalisation rates (p < 0.001) and shorter PED visits (1.7 [1.2-2.6] hours versus 4.0 [2.6-5.3] hours, p < 0.001) while receiving lower salbutamol doses (0.10 [0.05-0.16] mg/kg versus 0.81 [0.55-1.18] mg/kg, p < 0.001) with less ipratropium and oral corticosteroids (p < 0.001 and p < 0.001). The pMDI group demonstrated fewer side effects, particularly oxygen dependence, especially in children under 6 (p < 0.001).

CONCLUSION:

The study suggests that salbutamol via pMDI with a holding chamber is as effective as nebulisation for treating mild to moderate childhood asthma exacerbations. This approach results in fewer hospitalisations, reduced side effects, and shorter PED visits. Educating patients on pMDI use and efficacy could further decrease emergency visits for asthma exacerbation.

30 Jun 2025·Nederlands tijdschrift voor geneeskunde

[Unfounded objections against the use of salbutamol/ipratropium].

Review

Author: Piers, Sebastiaan R D ; Lucassen, Eliane A ; Tibboel, Jeroen ; Rood, Ragna

In acute bronchospasm due to asthma/COPD exacerbations two bronchodilators are frequently used: ipratropium, an acetylcholine antagonist, and salbutamol, a β2-agonist. The combination ipratropium/salbutamol gives more bronchodilation than ipratropium monotherapy in asthma/COPD exacerbations, but there are concerns about cardiac safety of salbutamol. Salbutamol in regular dosage does not affect heart rate in diverse populations (ED, ICU and children). Only a dosage 5-10x the standard dosage of 2,5 mg leads to a 20-30-beat increase in heart rate. High-dose salbutamol induced a mild increase of QTc interval (±360 to ±390ms) and QTc dispersion (maximum minus minimum QTc; marker for susceptibility to arrhythmia), but not to a clinically relevant extent. Most importantly, literature shows that the incidence of arrhythmia is similar between salbutamol and placebo. Salbutamol did not induce severe arrhythmias, including in arrhythmogenic ICU populations or in patients with severe COPD with cardiac comorbidity. We therefore argue that the current caution exercised with the use ipratropium/salbutamol is unjustified. Treatment should not be withheld in case of tachycardia or underlying heart disease.

01 Jun 2025·Asia Pacific Allergy

Intensive bronchial dilation test: A modified method for evaluating airway reversibility

Article

Author: Wang, Jianwei ; Zhang, Yu ; Sun, Yuemei ; Song, Xicheng ; Liu, Liping ; Cao, Jiayu ; Yang, Yujuan ; Tang, Ningbo ; Yu, Pengyi

Background::

A negative bronchial dilatation test (BDT) does not fully reflect the status of airway irreversibility in patients with severe obstructive or mixed ventilation dysfunction due to severe bronchospasm, mucus blockage, or insensitivity to bronchodilators, which will directly affect the subsequent diagnosis and treatment of those patients.

Objective::

We retrospectively examined the feasibility of using the “intensive bronchial dilation test” (IBDT) for excluding false-negative BDT.

Methods::

We retrospectively analyzed the clinical data of 82 patients with severe obstructive or mixed ventilation dysfunction in the Allergy department of Yantai Yuhuangding Hospital of Qingdao University. After the BDT, they all inhaled the triple atomized drugs (2 mg salbutamol, 1 mg budesonide, and 0.25 mg ipratropium) every 20 minutes in one hour and the lung function test was performed 15 minutes later, which was named as IBDT. All patients received another lung function test after 2 to 4 weeks of regular anti-inflammatory treatment. We compared the improvement of lung function indexes and the proportion of patients with reversible airway obstruction between BDT, IBDT, and 2 to 4 weeks of treatment groups.

Results::

The lung function indexes were significantly improved after the IBDT than those after the BDT (all P values < 0.01) and the number of patients with reversible airway obstruction significantly increased from 31 to 61 after the IBDT (P < 0.001), but the proportion of patients with reversible airway obstruction after the IBDT did not differ from that of patients with reversible airway obstruction after 2 to 4 weeks of treatment. The accuracy and sensitivity of the IBDT in evaluating airway reversibility reached 91.46% and 89.71%, respectively, both of which were significantly higher than for the BDT (54.88% and 45.59%, respectively).

Conclusion::

Our finding suggests that IBDT can more accurately and rapidly evaluate airway reversibility in patients with severe obstructive or mixed ventilation dysfunction when compared to BDT.

19

News (Medical) associated with Ipratropium Bromide

04 Aug 2025

·pharma.economictimes.indiatimes.com

NPPA sets retail prices of 37 drugs; notifies 4 scheduled formulations ceiling price

New Delhi: India’s drug price controller, NPPA has fixed the retail prices of 37 new drug including key type-2 diabetes formulations, antibiotics, cardiac therapies among several others. Issuing a gazette notification, the National Pharmaceutical Pricing Authority (NPPA) announced that the based on the decision of the 135th Authority meeting, the body has fixed retail prices of 37 formulations under Drugs (Prices Control) Order, 2013.” The notified list of 37 formulations includes key diabetes formulations of Empagliflozin, Sitagliptin, Meformin and Linagliptin. Additionally the list comprises formulation of Atorvastatin & Ezetimibe indicated for the treatment of high cholesterol and fats. The list further lunches other common anti-inflammatory formulations and drugs like Paracetamol, Diclofenac among several others. Under the Drugs Price Control Order any marketer, or manufacturers that intends to market a new drug in India is required to obtain a prior approval of the particular drug retail price from the NPPA and in case the fixed price is not complied, then the concerned manufacturer/marketing company is required to deposit the overcharged amount along with an interests per the relevant provision. However, the fixed retail prices are applicable only to the individual manufacturer / marketer who have applied for the same and are specified in the mentioned in the notified list. Meanwhile, in a separate gazette notification the national drug price controller has fixed the ceiling price of four scheduled formulations. The latest notified list includes Ipratropium, Sodium nitroprusside, Povidone iodine, and Diltiazem. Ipratropium is a ‘respirator solution’ indicated for the treatment of condictions like COPD and the drug ceiling price is capped at ₹2.96 per unit. Sodium nitroprusside is an injectable used to control high blood pressure and ceiling price of the formulation is fixed at ₹28.99. The other two scheduled formulations Povidone iodine and Diltiazem are used to treat skin infections and angina (severe chest pain), and the their ceiling price is fixed at ₹6.26 per ml and ₹26.72 per capsule respectively. According to the Ministry of Health and Family Welfare , the National list of Essential Medicines includes those formulations which are indicated for the treatment of diseases which is a public health problem in India, recommended under National Health Programs of India and several other factors. The prices of drugs categorised in the list are fixed and maintained by the NPPA to ensure the affordability of essential drugs for consumers and currently the list includes over 900 formulations. By Online Bureau ,

NDA

05 Jul 2025

·pharma.economictimes.indiatimes.com

Lupin launches Ipratropium Bromide nasal spray in US

New Delhi: Pharma major Lupin Ltd on Friday said it has launched Ipratropium Bromide nasal spray , used in treatment of runny nose, in the US market. The Ipratropium Bromide nasal solution ( nasal spray ) launched in the US is of strengths 0.03 per cent and 0.06 per cent, Lupin Ltd said in a regulatory filing. Ipratropium Bromide nasal spray 0.03 per cent and 0.06 per cent are bioequivalent to Atrovent nasal spray in the same strengths of Boehringer Ingelheim Pharmaceuticals , Inc, it added. Lupin said Ipratropium Bromide nasal spray 0.03 per cent is indicated for the symptomatic relief of rhinorrhea associated with allergic and nonallergic perennial rhinitis in adults and children aged 6 years and older. Ipratropium Bromide nasal spray 0.06 per cent is indicated for the symptomatic relief of rhinorrhea associated with the common cold or seasonal allergic rhinitis for adults and children aged 5 years and older, it added. Citing IQVIA MAT May 2025 data, the company said Ipratropium Bromide nasal solution (Atrovent) had estimated annual sales of USD 63 million in the US.

Drug Approval

29 Jan 2025

·pharma.economictimes.indiatimes.com

US FDA approves Lupin’s Generic Ipratropium Bromide nasal spray

Mumbai: The United States Food and Drug Administration (U.S. FDA) has approved Lupin Limited ’s Abbreviated New Drug Application (ANDA) for Ipratropium Bromide Nasal Solution (Nasal Spray), 0.06 per cent. The approval allows the company to market a generic version of Atrovent Nasal Spray , 0.06 per cent, manufactured by Boehringer Ingelheim Pharmaceuticals, Inc. It will be produced at Lupin’s facility in Pithampur, India. Ipratropium Bromide Nasal Solution (Nasal Spray), 0.06 per cent is indicated for symptomatic relief of rhinorrhea (runny nose) associated with the common cold or seasonal allergic rhinitis for adults and children aged 5 years and older. According to IQVIA MAT data from November 2024, the reference drug (RLD Atrovent) had estimated annual sales of approximately USD 42 million in the U.S. By Online Bureau ,

Drug Approval

100 Deals associated with Ipratropium Bromide

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External Link

KEGG	Wiki	ATC	Drug Bank
D02212	Ipratropium Bromide	R03BB01 R01AX03	DBSALT000208

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Rhinitis, Allergic, Seasonal	United States	Boehringer Ingelheim Pharmaceuticals, Inc.	27 Oct 2000
Common Cold	United States	Boehringer Ingelheim Pharmaceuticals, Inc.	20 Oct 1995
Rhinitis	United States	Boehringer Ingelheim Pharmaceuticals, Inc.	20 Oct 1995
Bronchial Spasm	United States	Boehringer Ingelheim Pharmaceuticals, Inc.	29 Sep 1993
Pulmonary Disease, Chronic Obstructive	United States	Boehringer Ingelheim Pharmaceuticals, Inc.	29 Sep 1993
Asthma	Japan	Teijin Pharma Ltd.	25 Oct 1980
Bronchitis, Chronic	Japan	Teijin Pharma Ltd.	25 Oct 1980
Pulmonary Emphysema	Japan	Teijin Pharma Ltd.	25 Oct 1980

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Dyspnea	Clinical	Canada	Boehringer Ingelheim GmbH	01 Oct 2008

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT00583778 (CTgov)	Not Applicable	Acute asthma	141	ipratropium (Levalbuterol)	zcrtgdaiem = baievulgnb pugslyeqyk (ltpdkyjrrc, fyqfzjwkkv - bnnjqbbvly) View more	-	16 May 2022
				ipratropium (Levalbuterol Plus Ipratropium)	zcrtgdaiem = oznahtscca pugslyeqyk (ltpdkyjrrc, rlfjtfkege - cbuexljpwg) View more
NCT03219866 (CTgov)	Phase 4	Pulmonary Disease, Chronic Obstructive	40	Nebulizers+Pulmicort+Brovana+Atrovent (Nebulizers)	kxocstkmpt(fvtnjmyrxx) = opiamageue otribbqthu (ujpvrzrmys, 25.2) View more	-	10 Jun 2021
				Dry Powder Inhaler+Spiriva HandiHaler+Advair Diskus (Dry Powder Inhaler)	kxocstkmpt(fvtnjmyrxx) = atyncbeacu otribbqthu (ujpvrzrmys, 19.8) View more
NCT01691079 (STAMINA, CTgov)	Phase 4	Asthma, Exercise-Induced	20	Placebo (Placebo)	chcollbigy(xyqtvmzejc) = kufjslbbzd zefssmhqmq (qpxfctwhrs, tsmahkesnh - pdsssxsjwu) View more	-	05 Jun 2020
				ipratropium bromide (Ipratropium Bromide)	chcollbigy(xyqtvmzejc) = grwhyljtfn zefssmhqmq (qpxfctwhrs, pwjscmajgj - hgtssxsvan) View more
NCT01696214 (SAPS, CTgov)	Phase 4	Asthma	20	ipratropium (Ipratropium)	ngazkgavaf(jaadirfmxv) = phpflcbiux qetyqudnuc (ixsunodhol, xansrgouch - hzepdwnuhq) View more	-	12 Oct 2016
				Theophylline 400 mg (Theophylline)	ngazkgavaf(jaadirfmxv) = fspfmbmmok qetyqudnuc (ixsunodhol, oinitwvaps - fgvgbkgndq) View more
NCT01943552 (CTgov)	Phase 4	Pulmonary Disease, Chronic Obstructive	192	placebo	ypcpwiaoiq(ukfgrpnlom) = zfuxnodkjz pbqhxkingp (xxdocmilmw, 29.35) View more	-	12 Sep 2016
NCT01987219 (CTgov)	Phase 3	Dysautonomia, Familial	15	Albuterol-sulphate (Albuterol-sulphate)	cvolplcnrz(nwdatsqsvo) = snfnfxalpe qgvbimeqpy (zxuitfojfl, 13.6) View more	-	02 Jun 2016
				Ipratropium-bromide (Ipratropium-bromide (Atrovent ®))	cvolplcnrz(nwdatsqsvo) = bvrtukdiaw qgvbimeqpy (zxuitfojfl, 10.9) View more
ACTRN12607000383460 (Pubmed \| J Paediatr Child Health)	Not Applicable	Childhood asthma	-	Salbutamol, Prednisolone, and Ipratropium Bromide	acdbvlisjw(exzlvkclrp) = zxfudcocer rttjjooyfm (pjotwpwtsi ) View more	-	01 Feb 2015
				Salbutamol and Prednisolone	acdbvlisjw(exzlvkclrp) = pmfqpqovhg rttjjooyfm (pjotwpwtsi ) View more
NCT01415518 (SECURE2, CTgov)	Phase 4	Pulmonary Disease, Chronic Obstructive	581	Theophylline+Symbicort Turbuhaler+Ipratropium (Symbicort Turbuhaler + Ipratropium + Theophylline SR)	vndjirhqyo(ujbbecgzep) = ubflybavjr dyoirkmyfr (infhxteltv, zvymzpmifi - awcbabarkr) View more	-	26 Aug 2014
				Theophylline+Ipratropium (Ipratropium + Theophylline SR)	vndjirhqyo(ujbbecgzep) = oxdkomolre dyoirkmyfr (infhxteltv, pflinojfmx - lkokprayyq) View more
NCT01691482 (CTgov)	Phase 4	Pulmonary Disease, Chronic Obstructive	56	Albuterol/salbutamol (Albuterol/Salbutamol Followed by Ipratropium)	spzovqdfmu(qhnzmfidtq) = exqxwhgatm lgsulxytfw (dsxkyuiqfe, 0.0394) View more	-	25 Dec 2013
				Ipratropium (Ipratropium Followed by Albuterol/Salbutamol)	spzovqdfmu(qhnzmfidtq) = xdoouzmmqo lgsulxytfw (dsxkyuiqfe, 0.0372) View more