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Last update 27 Feb 2026

Beclometasone Dipropionate

Last update 27 Feb 2026

Overview

R&D Status

Clinical Result

Translational Medicine

Overview

Basic Info

Drug Type

Small molecule drug

Synonyms

(11β,16β)-9-chloro-11-hydroxy-16-methyl-17,21-bis(1-oxopropoxy)pregna-1,4-diene-3,20-dione, 9-chloro-11β-hydroxy-16β-methylpregna-1,4-diene-3,20-dione 17,21-dipropionate, 9-chloro-16β-methyl-11β,17,21-trihydroxypregna-1,4-diene-3,20-dione 17,21-dipropionate

+ [49]

Target

Action

agonists

Mechanism

GR agonists(Glucocorticoid receptor agonists)

Therapeutic Areas

Immune System DiseasesInfectious DiseasesOtorhinolaryngologic Diseases+ [3]

Active Indication

Rhinitis, Allergic, SeasonalAsthmaRhinitis, Allergic+ [2]

Inactive Indication

Acute sinusitisAirway ObstructionBronchial Hyperreactivity+ [18]

Originator Organization

Merck & Co., Inc.

Active Organization

Guangdong San Lan Pharmaceutical Co. Ltd.

Soligenix, Inc.

Tianjin Jinyao Pharmaceutical Co., Ltd.

+ [3]

Inactive Organization

CHIESI Farmaceutici SpAAllergan UC

Teva Pharmaceutical Industries Ltd.

+ [4]

License Organization-

Drug Highest PhaseApproved

First Approval Date

United States (12 May 1976),

AsthmaRhinitis, Allergic

Regulation-

Structure/Sequence

Molecular FormulaC28H37ClO7

InChIKeyKUVIULQEHSCUHY-XYWKZLDCSA-N

CAS Registry5534-09-8

198

Clinical Trials associated with Beclometasone Dipropionate

ChiCTR2600118322

/ Not yet recruitingEarly Phase 1

A randomized, open-label, controlled, proof of concept trial to evaluate the efficacy of extra fine particle inhaled triple therapy in preventing progression to COPD in high-risk individuals with pre-COPD: a study protocol

Start Date09 Feb 2026

Sponsor / Collaborator-

CTR20260055

/ Active, not recruitingNot Applicable

吸入用丙酸倍氯米松混悬液在中国健康受试者中空腹状态下单剂量、随机、开放、两周期、两序列、双交叉设计的生物等效性试验

[Translation] A bioequivalence study of beclomethasone dipropionate inhalation suspension in healthy Chinese subjects under fasting conditions, using a single-dose, randomized, open-label, two-period, two-sequence, two-crossover design.

主要研究目的研究空腹状态下吸入用丙酸倍氯米松混悬液受试制剂（规格2ml:0.8mg，苏州弘森药业股份有限公司生产）与吸入用丙酸倍氯米松混悬液参比制剂（规格2ml:0.8mg，Chiesi Farmaceutici S.p.A.持证）在中国健康受试者体内的药代动力学行为，评价空腹状态下两种制剂的生物等效性。次要研究目的评价中国健康受试者空腹状态下单次使用受试制剂（T）吸入用丙酸倍氯米松混悬液和参比制剂（R）吸入用丙酸倍氯米松混悬液后的安全性。

[Translation]

Primary Objective: To investigate the pharmacokinetic behavior of the test formulation of beclomethasone dipropionate inhalation suspension (2 ml: 0.8 mg, manufactured by Suzhou Hongsen Pharmaceutical Co., Ltd.) and the reference formulation of beclomethasone dipropionate inhalation suspension (2 ml: 0.8 mg, certified by Chiesi Farmaceutici S.p.A.) in healthy Chinese subjects under fasting conditions, and to evaluate the bioequivalence of the two formulations under fasting conditions. Secondary Objective: To evaluate the safety of a single administration of the test formulation (T) and the reference formulation (R) of beclomethasone dipropionate inhalation suspension in healthy Chinese subjects under fasting conditions.

Start Date22 Jan 2026

Sponsor / Collaborator

Suzhou Homesun Pharmaceutical Co. Ltd.

CTR20253991

/ RecruitingPhase 3

评价丙酸倍氯米松吸入气雾剂治疗成人支气管哮喘的有效性和安全性的多中心、随机、双盲、阳性药物平行对照、非劣效临床试验。

[Translation] A multicenter, randomized, double-blind, active drug parallel-controlled, non-inferiority clinical trial to evaluate the efficacy and safety of beclomethasone dipropionate inhalation aerosol in the treatment of adult bronchial asthma.

主要目的：与Clenil® Modulite®吸入气雾剂（以下简称为阳性药）比较，评估丙酸倍氯米松吸入气雾剂（以下简称为丙酸倍氯米松）治疗成人支气管哮喘的有效性。次要目的：评估丙酸倍氯米松吸入气雾剂相比Clenil® Modulite®吸入气雾剂治疗成人支气管哮喘的安全性。

[Translation]

Primary objective: To evaluate the effectiveness of beclomethasone dipropionate inhalation aerosol (hereinafter referred to as beclomethasone dipropionate) in the treatment of adults with bronchial asthma, compared with Clenil® Modulite® inhalation aerosol (hereinafter referred to as the active drug). Secondary objective: To evaluate the safety of beclomethasone dipropionate inhalation aerosol compared with Clenil® Modulite® inhalation aerosol in the treatment of adults with bronchial asthma.

Start Date12 Dec 2025

Sponsor / Collaborator

Hefei Licheng Pharmaceutical Co., Ltd.

100 Clinical Results associated with Beclometasone Dipropionate

100 Translational Medicine associated with Beclometasone Dipropionate

100 Patents (Medical) associated with Beclometasone Dipropionate

3,652

Literatures (Medical) associated with Beclometasone Dipropionate

01 Mar 2026·RESPIRATORY MEDICINE

The impact of stepping up treatment from LABA/LAMA to extrafine single inhaler triple therapy on exacerbations of Greek patients with Chronic Obstructive Pulmonary Disease: The IMPROVE study

Article

Author: Rovina, Nikoletta ; Bartziokas, Konstantinos ; Bakakos, Petros ; Loukides, Stylianos ; Kosmas, Epaminondas ; Efstathopoulos, Petros ; Georgatou, Niki ; Kostikas, Konstantinos ; Steiropoulos, Paschalis ; Papapostolou, Evangelia ; Papapetrou, Dimosthenis ; Katerelos, Panos

OBJECTIVE:

Extrafine single inhaler triple therapy (efSITT) with beclometasone dipropionate, formoterol fumarate, and glycopyrronium (BDP/FF/G 87/5/9 μg) has shown clinical benefits in Chronic Obstructive Pulmonary Disease (COPD) patients, including fewer exacerbations in randomized controlled trials. The IMPROVE study evaluated its real-world effectiveness in Greece in COPD patients previously treated with dual bronchodilation, focusing on exacerbations and other clinical outcomes.

METHODS:

This prospective, multicenter, observational study was conducted over 52 weeks. The 1103 eligible patients had moderate-to-severe COPD, an indication for treatment with efSITT, and were symptomatic despite receiving dual bronchodilation. The number of exacerbations, COPD Assessment Test (CAT) score, lung function parameters, use of rescue medication and adherence were recorded at baseline (visit 1), 6 months (visit 2), and 12 months (visit 3) after treatment.

RESULTS:

The percentage of patients with ≥1 exacerbation decreased from 100 % at visit 1 to 23.1% at visit 3 (p < 0.001). The mean CAT score decreased from 22.5 points at visit 1, to 16.6 at visit 2 and 14.2 at visit 3 (p < 0.001 for all pair comparisons). The mean TAI score increased from 44.6 points at visit 1, to 47.1 at visit 2 and 47.6 at visit 3. (p < 0.001 for V1/2 and V1/3 pairs, p = 0.024 for V2/3). Between visit 1 and visit 3, mean FEV1 increased from 1.6 L to 1.7 L (p < 0.001, n = 396).

CONCLUSIONS:

The IMPROVE findings indicate that extrafine BDP/FF/G improves clinical outcomes in symptomatic COPD patients previously treated with dual bronchodilation in a real-world setting in Greece.

01 Feb 2026·BMJ Evidence-Based Medicine

Adverse events of inhaled corticosteroids in adult patients with asthma or chronic obstructive pulmonary disease: pairwise, network and dose–response meta-analyses

Review

Author: Wang, Guojun ; Peng, Li ; Jiang, Xinrui ; Pu, Xiaofeng ; Huang, Yunbei ; Zhang, Yinhui ; Zhang, Zhengji ; Wang, Maolin ; Xu, Mengyao

Objectives:

This study aimed to evaluate the associations between inhaled corticosteroids (ICSs) and adverse events (AEs) in adults with asthma or chronic obstructive pulmonary disease (COPD) and to explore variations by ICS type and dosage.

Design and setting:

Medline/PubMed, Embase, the Cochrane Central Register of Controlled Trials and ClinicalTrials.gov were searched from inception to 20 February 2025. Data extraction and synthesis were performed, estimating risk ratios (RRs) with 95% confidence intervals (CI) or credible intervals (CrI) through pairwise and network meta-analysis (NMA), and an NMA using the Emax model was employed to find the dose–response relationships of the AEs of each ICS. Risk of bias was evaluated across both pairwise and NMAs. The certainty of evidence, based on the GRADE approach, was assessed exclusively for the NMA estimates.

Participants:

Adults diagnosed with asthma or COPD treated with ICSs compared with non-ICS controls or those receiving different types or doses of ICSs.

Main outcome measures:

The primary outcomes were AEs, including pneumonia, oral candidiasis, upper respiratory tract infection (URTI), fracture, diabetes, cataract and plasma cortisol abnormalities. Secondary outcomes included efficacy-related endpoints: asthma exacerbations, COPD exacerbations and all-cause mortality.

Results:

129 trials (120 900 participants) were included. According to pairwise meta-analysis, ICSs were associated with a higher risk of pneumonia (RR 1.49, 95% CI 1.38 to 1.61) and oral candidiasis (RR 2.29, 95% CI 2.01 to 2.60) and with a slightly higher risk of URTI (RR 1.17, 95% CI 1.10 to 1.25), compared with control. Besides, ICSs were linked to a reduced risk of asthma exacerbations (RR 0.30, 95% CI 0.20 to 0.45) and COPD exacerbations (RR 0.90, 95% CI 0.86 to 0.94) vs control. The results of the NMA that explored differences by ICS type showed that beclomethasone and fluticasone increased pneumonia risk compared with control, with absolute risk increases of up to 2.3%. Fluticasone also showed a slightly higher pneumonia risk than budesonide. Besides, mometasone, beclomethasone, budesonide and fluticasone were associated with increased risk of oral candidiasis, with the highest increase observed for mometasone (4.3%). In contrast, ciclesonide consistently showed lower risk across comparisons, reducing oral candidiasis by up to 4.5% with other ICSs. Fluticasone modestly increased URTI, while ciclesonide reduced it. Budesonide and mometasone were also associated with a small increase in cataract risk. Most of the outcomes reported here were supported by moderate- to high-certainty evidence. Furthermore, the dose–response relationship estimated from the Emax model indicated significant associations between fluticasone dose and the risks of pneumonia and URTI, between multiple ICS doses and oral candidiasis and between budesonide dose and cataract.

Conclusions:

ICSs are correlated with the escalated risk of pneumonia, oral candidiasis and URTI in adult patients with asthma or COPD, but ICSs could reduce asthma exacerbations and COPD exacerbations. Fluticasone, beclomethasone, budesonide and mometasone are independently linked to certain AEs, and some Emax dose–response relationships are detected.Our findings may help guide individualised ICS use by informing benefit-risk considerations across various formulations and dosing regimens.

PROSPERO registration number:

CRD42024527797.

01 Feb 2026·OTOLARYNGOLOGY-HEAD AND NECK SURGERY

Evaluation of Off‐Label Postoperative Inhaled Steroid Use in Tracheal and Cricotracheal Resection

Article

Author: Alexander Tu Hong BS ; Jason Shin Chwa BS ; Elizabeth Ann Shuman MD ; Karla O'Dell MD

Abstract:

Objective:

Tracheal resection (TR) and cricotracheal resection (CTR) are associated with anastomotic complications. Off‐label use of inhaled corticosteroids has gained popularity for reducing tracheal granulation tissue, though adoption remains limited due to unclear safety and efficacy. This study used a national database to evaluate associations between postoperative inhaled steroid use and adverse effects, granulation tissue formation, and repeat surgical intervention.

Study Design:

Retrospective cohort study.

Setting:

Multicenter study using TriNetX, a federated electronic health records network.

Methods:

Adult patients undergoing TR/CTR between March 2005 and March 2025 who received inhaled steroids (ciprofloxacin‐dexamethasone, dexamethasone, budesonide, fluticasone, mometasone, and beclomethasone) within 1 day postoperatively were included. Patients were excluded if they had diagnoses commonly requiring similar medications or received study agents within 1 month before surgery. Propensity score matching balanced covariates, and odds ratios (ORs) with 95% confidence intervals (CIs) were calculated for outcomes at 30 days and 3 months. Outcomes included adverse safety events, granulation tissue formation, and repeat airway surgery.

Results:

The matched cohort included 284 patients in each group. Inhaled steroid use was associated with decreased odds of adverse safety side effects, granulation formation, and repeat airway surgeries at both timepoints, though only repeat procedures at 30 days reached statistical significance (OR 0.60, 95% CI 0.42‐0.85).

Conclusion:

Postoperative inhaled steroid use in TR/CTR patients demonstrated excellent safety with no increased adverse events and was associated with a significant 40% reduction in the incidence of repeat surgeries within 30 days. Further studies should assess potential clinical benefits more definitively.

News (Medical) associated with Beclometasone Dipropionate

02 Dec 2025

·www.globenewswire.com

Amneal Receives U.S. FDA Approval for Albuterol Sulfate Inhalation Aerosol

Represents second complex respiratory therapeutic product approval in Q4 2025BRIDGEWATER, N.J., Dec. 02, 2025 (GLOBE NEWSWIRE) -- Amneal Pharmaceuticals, Inc. (“Amneal” or the “Company”) (Nasdaq: AMRX) today announced that the U.S. Food and Drug Administration (FDA) has approved the Company’s albuterol sulfate inhalation aerosol (90 mcg per actuation). The product is the generic equivalent of PROAIR® HFA (albuterol sulfate inhalation aerosol), a registered trademark of Teva Respiratory LLC. This approval follows the Company’s FDA approval of its beclomethasone dipropionate inhalation aerosol, a generic equivalent of QVAR® (beclomethasone dipropionate inhalation aerosol), further advancing Amneal’s entry into complex inhaled and respiratory drug delivery. Together, these milestones underscore the Company’s momentum in building a differentiated, high-value respiratory portfolio supported by its state-of-the-art manufacturing platform. “Securing two significant inhalation approvals this quarter—first beclomethasone dipropionate and now albuterol—highlights the tremendous progress our teams have made in a highly complex respiratory category,” said Dr. Srinivas Kone, Senior Vice President, Chief Scientific Officer – Affordable Medicines. “These achievements are the result of years of hard work, engineering excellence, and investment in our respiratory platform, and they position Amneal to deliver meaningful growth and patient impact.” Albuterol sulfate inhalation aerosol is indicated for the treatment or prevention of bronchospasm in adults and children 12 years of age and older with reversible obstructive airway disease. The most common adverse reactions (≥3.0% and >placebo) are headache, tachycardia, pain, dizziness, pharyngitis, and rhinitis. For full prescribing information, see package insert here. According to IQVIA® U.S. annual sales for albuterol sulfate inhalation aerosol for the 12 months ended September 2025 were approximately $1.5 billion. PROAIR® HFA and QVAR® are registered trademarks of Teva Respiratory LLC. About AmnealAmneal Pharmaceuticals, Inc. (Nasdaq: AMRX), headquartered in Bridgewater, NJ, is a global biopharmaceutical company. We make healthy possible through the development, manufacturing, and distribution of a diverse portfolio of over 290 pharmaceuticals, primarily within the United States. In its Affordable Medicines segment, the Company is expanding across a broad range of complex product categories and therapeutic areas, including injectables and biosimilars. In its Specialty segment, Amneal has a growing portfolio of branded pharmaceuticals focused primarily on central nervous system and endocrine disorders. Through its AvKARE segment, the Company is a distributor of pharmaceuticals and other products for the U.S. federal government, retail, and institutional markets. For more information, please visit www.amneal.com and follow us on LinkedIn. Cautionary Statement on Forward-Looking StatementsCertain statements contained herein, regarding matters that are not historical facts, may be forward-looking statements (as defined in the U.S. Private Securities Litigation Reform Act of 1995). Such forward-looking statements include statements regarding management’s intentions, plans, beliefs, expectations, financial results, or forecasts for the future, including among other things: discussions of future operations; expected or estimated operating results and financial performance; and statements regarding our positioning, including our ability to drive sustainable long-term growth, and other non-historical statements. Words such as “plans,” “expects,” “will,” “anticipates,” “estimates,” and similar words, or the negatives thereof, are intended to identify estimates and forward-looking statements. The forward-looking statements contained herein are also subject generally to other risks and uncertainties that are described from time to time in the Company’s filings with the Securities and Exchange Commission, including under Item 1A, “Risk Factors” in the Company’s most recent Annual Report on Form 10-K and in its subsequent reports on Forms 10-Q and 8-K. Forward-looking statements included herein speak only as of the date hereof and we undertake no obligation to revise or update such statements to reflect the occurrence of events or circumstances after the date hereof. Investor Contact Anthony DiMeoVP, Investor Relations anthony.dimeo@amneal.com Media ContactBrandon SkopSr. Director, Corporate Communicationsbrandon.skop@amneal.com

Drug Approval

15 Oct 2025

·www.globenewswire.com

Chiesi Announces FDA Acceptance of New Drug Application for its Triple Combination Inhaler for the Maintenance Treatment of Asthma

Asthma remains a significant health burden in the U.S., with more than 60% of adults continuing to experience frequent symptoms despite the availability of many treatments.1Chiesi’s single inhaler triple therapy (beclomethasone dipropionate/formoterol fumarate/glycopyrrolate) is designed for the maintenance treatment of asthma in adults, aiming to lower the burden of uncontrolled asthma in the U.S.Chiesi’s single inhaler triple therapy was the first approved in its class outside of the U.S. – and currently commercialized in nearly 50 countries – and its NDA submission signals the company’s expansion of its more than 45 years of leading respiratory expertise to the U.S. market. CARY, N.C., Oct. 15, 2025 (GLOBE NEWSWIRE) -- Chiesi USA, Inc. (key-A-zee), a biopharmaceutical company that supports patients in living their best possible lives through life-changing or lifesaving innovations, today announced that the U.S. Food and Drug Administration has accepted the company’s New Drug Application (NDA) for its investigational maintenance treatment of asthma in adults. Chiesi’s inhaler delivers three active ingredients in a single device, referred to as a single inhaler triple therapy (SITT). Already approved in nearly 50 countries, this product is marketed outside of the U.S. under the brand name TRIMBOW®. “The FDA’s acceptance of Chiesi’s New Drug Application for our fixed-dose triple combination inhaler represents another important step in our journey to delivering solutions that address respiratory needs and reduce the burden that persists for people living with asthma, their caregivers, and the healthcare system in the U.S.,” said Martin Marciniak, Vice President of U.S. Medical Affairs at Chiesi. “Respiratory care is in our DNA--we have created medicines in this area for more than four decades, and transformed respiratory care by creating and commercializing the first triple therapy for asthma outside the U.S. We are bringing our respiratory expertise to the U.S. to help even more people live healthier lives.” Chiesi’s inhaler delivers three active ingredients, beclomethasone dipropionate (BDP), an inhaled corticosteroid; formoterol fumarate (FF), a long-acting beta-agonist (LABA); and glycopyrrolate (G), an anticholinergic in a single device, referred to as a fixed dose triple combination inhaler. It is administered as twice daily in a pressurized metered-dose inhaler (pMDI). The NDA is supported in part by data from the TRIMARAN and TRIGGER studies, which are double-blind, parallel group, randomized, active-controlled Phase 3 trials. These studies evaluated the safety and efficacy of the triple inhaler ingredients (BDP/FF/G) in more than 2,500 patients with uncontrolled asthma.2 “Among the 28 million people in the U.S. who have asthma, many experience symptoms that disrupt daily life and have lasting effects on their lung health and function--and tragically, nine people die from asthma complications every day3,” said Kenneth Mendez, President and CEO of the Asthma and Allergy Foundation of America. “New treatment options offer the potential for improved asthma management. Expanding choices means more opportunities for patients and their care teams to find solutions that meet individual needs and improve quality of life.” Chiesi’s single inhaler triple therapy pressurized metered dose inhaler was the first approved in its class outside of the U.S. and is commercialized in nearly 50 countries, including the European Union, the United Kingdom and China. About AsthmaAsthma is a chronic, inflammatory respiratory disease that causes inflammation in the airways. People who have asthma can experience symptoms such as shortness of breath, wheezing, coughing and chest tightness – often every day for those with severe cases.4 More than 25 million people in the U.S. live with asthma, and for many adults, symptoms remain difficult to manage even with existing treatments.5 In fact, an estimated 60% of adults with asthma continue to experience frequent symptoms, which can lead to trips to the emergency room, interruption to daily activities, missed work, and a lower quality of life.1 Severe asthma attacks can be life-threatening. Centers for Disease Control and Prevention (CDC) data show that more than 3,600 adults die from asthma each year in the U.S., which is an average of nine deaths per day.6 Asthma also places a major burden on the healthcare system and economy, costing the U.S. an estimated $82 billion annually.7 About beclomethasone dipropionate/formoterol fumarate/glycopyrrolateBeclomethasone dipropionate/formoterol fumarate/glycopyrrolate is an investigational, triple combination inhaler under FDA review in the U.S. for maintenance treatment of asthma in adults. It contains three active ingredients: beclomethasone dipropionate (BDP), an inhaled corticosteroid; formoterol fumarate (FF), a long-acting beta-agonist (LABA); and glycopyrrolate (G), an anticholinergic. It is administered as twice-daily, fixed-dose therapy in a pressurized metered-dose inhaler (pMDI) using a particle formulation designed for deep lung deposition. Chiesi’s robust clinical trial program evaluated the safety and efficacy of BDP/FF/G in more than 2,500 patients with uncontrolled asthma. It was the world’s first fixed triple combination in a single inhaler and is commercialized in nearly 50 countries outside of the U.S., including the United Kingdom, the European Union and China. About Chiesi USA Chiesi USA, Inc., headquartered in Cary, North Carolina, is a specialty pharmaceutical company focused on the commercialization of products for the hospital and target office-based specialties. Chiesi USA is a wholly owned subsidiary of privately-owned Chiesi Farmaceutici S.p.A, a global R&D-focused pharmaceutical company based in Parma, Italy. In the United States, the company delivers therapies and enhances care for patients in the areas of acute cardiology, neonatology, cystic fibrosis and rare diseases. Recognized as a Certified B Corporation™, Chiesi is dedicated to improving the health and well-being of its communities through its employee-led corporate social responsibility program, Chiesi in the Community. Innovation, collaboration and impact are the cornerstones of the Chiesi culture. For more information, visit www.chiesiusa.com. Media InquiriesChiesi US Media Relationsus.mediarelations@chiesi.com ____________________________ 1 Centers for Disease Control and Prevention (CDC). (2022, July 1). Uncontrolled Asthma Among Adults, 2019. National Center for Environmental Health. 2 Virchow, Johann Christian et al. Single inhaler extrafine triple therapy in uncontrolled asthma (TRIMARAN and TRIGGER): two doubleblind, parallel-group, randomised, controlled phase 3 trials. The Lancet, Volume 394, Issue 10210, 1737 - 17493 Asthma and Allergy Foundation of America. (2025). Asthma facts and figures. https://aafa.org/wp-content/uploads/2025/04/aafa-asthma-facts-and-figures-1.pdf 4 Centers for Disease Control and Prevention. (2023, September 27). Asthma: About. U.S. Department of Health & Human Services. https://www.cdc.gov/asthma/about/index.html5 Centers for Disease Control and Prevention. (2023, October 5). Asthma surveillance in the United States: 2001–2021 [Data brief]. U.S. Department of Health & Human Services. https://www.cdc.gov/asthma/Asthma-Prevalence-US-2023-508.pdf6 Centers for Disease Control and Prevention. (2024, February 13). Asthma. National Center for Health Statistics. https://www.cdc.gov/nchs/fastats/asthma.htm7 Nurmagambetov, T., Kuwahara, R., & Garbe, P. (2017). State-level medical and absenteeism cost of asthma in the United States. Journal of Asthma, 54(4), 357–370. https://doi.org/10.1080/02770903.2016.1218013 PDF available: http://ml.globenewswire.com/Resource/Download/06cdebc6-ba1c-45f0-a06c-0feffd63ae04

Phase 3Drug ApprovalClinical ResultNDA

23 Aug 2024

·pharma.economictimes.indiatimes.com

Govt bans 156 medicines including antibiotics, painkillers, multivitamins: Here is the full list

New Delhi: In a significant move aimed at safeguarding public health, the Indian government has banned 156 fixed-dose combination (FDC) drugs, including a variety of antibiotics, painkillers, multivitamins, and medications for treating fever and hypertension. This decision marks the largest crackdown on FDCs since 2016, when 344 such drugs were prohibited. The Union Ministry of Health and Family Welfare issued a gazette notification on Thursday, officially prohibiting the manufacture, sale, and distribution of the banned FDCs. The ban was based on the recommendations of an expert panel that reviewed a total of 324 FDCs. Impact on Pharmaceutical Industry The banned FDCs include popular combinations such as mefenamic acid and paracetamol injections, commonly used for pain relief and fever, and omeprazole magnesium with dicyclomine HCl, used to treat abdominal pain. The ban is expected to impact major pharmaceutical companies, including Sun Pharmaceuticals, Cipla, Dr. Reddy's Laboratories, Torrent Pharmaceuticals, and Alkem Laboratories. Fixed Dose Combinations Drug Banned List Here is a table listing all 156 banned Fixed Dose Combinations (FDCs) SN Fixed Dose Combination (FDC) 1 Amylase + Protease + Glucoamylase + Pectinase + Alpha Galactosidase + Lactase + Beta-Gluconase + Cellulase + Lipase + Bromelain + Xylanase + Hemicellulase + Malt diastase + Invertase + Papain 2 Antimony Potassium Tartrate + Dried Ferrous Sulphate 3 Benfotiamine + Silymarin + L-Ornithine L-aspartate + Sodium Selenite + Folic acid + Pyridoxine hydrochloride 4 Bismuth Ammonium Citrate + Papain 5 Cyproheptadine HCl + Thiamine HCl + Riboflavine + Pyridoxine HCl + Niacinamide 6 Cyproheptadine Hydrochloride + Tricholine Citrate + Thiamine Hydrochloride + Riboflavine + Pyridoxine Hydrochloride 7 Rabeprazole Sodium (As enteric coated tablet) + Clidinium Bromide + Dicyclomine HCl + Chlordiazepoxide 8 Fungal Diastase + Papain + Nux vomica Tincture + Cardamom Tincture + Casein Hydrolysed + Alcohol 9 Mefenamic Acid + Paracetamol Injection 10 Omeprazole Magnesium + Dicyclomine HCl 11 S-adenosyl methionine + Metadoxine + Ursodeoxycholicacid BP + L-Methylfolate Calcium eq. to L- Methylfolate + Choline bitartratee + Silymarin + L-ornithine Laspartate + Inositol + Taurine 12 Silymarin + Thiamine Mononitrate + Riboflavin + Pyridoxine HCl + Niacinamide + Calcium pantothenate + Vitamin B12 13 Silymarin + Pyridoxine HCl + Cyanocobalamin + Niacinamide + Folic Acid 14 Silymarin + Vitamin B6 + Vitamin B12 + Niacinamide + Folic acid + Tricholine Citrate 15 Sodium Citrate + Citric Acid Monohydrate Flavored with Cardamom Oil, Caraway Oil, Cinnamon Oil, Clove Oil, Ginger Oil + Alcohol 16 Sucralfate + Acelofenac 17 Sucralfate + Domperidone + Dimethicone 18 Sucralfate + Domperidone 19 Tincture Ipecacuanha + Tincture Urgenia + Camphorated Opium Tincture + Aromatic Spirit of Ammonia + Chloroform + Alcohol 20 Ursodeoxycholic Acid + Metformin HCl 21 Weak Ginger tincture + Aromatic Spirit of Ammonia + Peppermint Spirit + Chloroform + Sodium Bicarbonate + Compound Cardamom + Alcohol 22 Sucralfate + Pantoprazole Sodium + Zinc Gluconate + Light Magnesium Carbonate 23 Aloe + Vitamin E Soap 24 Povidone Iodine+ Metronidazole + Aloe 25 Azelaic acid + Tea Tree Oil + Salicylic acid + Allantoin + Zinc oxide + Aloe vera + Jojoba oil + Vitamin E + Soap noodles 26 Azithromycin + Adapalene 27 Calamine + Aloes + Allantoin 28 Calamine + Diphenhydramine Hydrochloride + Aloe + Glycerine + Camphor 29 Chlorphenesin + Zinc oxide + Starch 30 Clindamycin Phosphate + Zinc acetate 31 Gamma Benzene Hexachloride + Benzocaine 32 Glucosamine hydrochloride + Diacerein + Menthol + Camphor + Capsaicin 33 Hydroxyquinone 2.0%w/w + Octyl Methoxycinnamate 5.0% w/w + Oxybenzone 30 % w/w 34 Ketoconazole +Zinc Pyrithione +D-Panthenol +Tea Tree Oil +Aloes 35 Ketoconazole +Aloe vera+ Vitamin A Acetate 36 Ketoconazole +Aloes + ZPTO 37 Kojic Acid +Arbutin +Octinoxate +Vitamin E + Mulberry 38 Lornoxicam +capsaicin +menthol+ camphor 39 Lornoxicam + Thiocolchicoside +Oleum Lini +Menthol + Methyl salicylate 40 Menthol + Aloe vera Topical Spray 41 Menthol +Lignocaine HCl +Aloe vera gel +Clotrimazole +Diphenhydramine 42 Miconazole nitrate + Gentamicin + Fluocinolone Acetonide +Zinc Sulphate 43 Miconazole +Tinidazole 44 Minoxidil +Aminexil+ Alcohol 45 Minoxidil +Azelaic acid + saw palmetto 46 Minoxidil +Aminexil 47 Pine Bark extract+ Kojic acid +Sodium Ascorbyl Phosphate 48 Povidone Iodine +Tinidazole +Zinc sulphate 49 Povidone Iodine + Ornidazole + Dexpanthenol 50 Salicyclic acid +Aloe vera+ Allantoin +D-Panthenol 51 Silver sulphadiazine +Chlorhexidine Gluconate solution +Allantoin + Aloe vera gel +Vitamin E acetate 52 Sodium salicylate + Zinc gluconate + Pyridoxine HCl 53 Tetracycline + Colistin Sulphate 54 Clomiphene +Ubidecarenone 55 Combikit of Clomiphene Citrate + Estradiol Valerate 56 Flavoxate HCl +Ofloxacin 57 Clomiphene Citrate +N-Acetylcysteine 58 Primerose Oil +Cod liver oil 59 Sildenafil Citrate +Papaverine +L-Arginine 60 Tranexamic acid +Mefenamic acid + Vitamin K1 61 Divalproex Sodium +Oxcarbazepine 62 Divalproex Sodium + Levetiracitam 63 Ergotamine tartrate +Caffeine + Paracetamol +Prochlorperazine maleate 64 Piracetam + Ginkgo biloba extracts + Vinpocetin 65 Ginkgo biloba + methylcobalamin 66 Ginkgo biloba + methylcobalamin + Alpha lipoic acid +Pyridoxine HCl 67 Ginseng Extract +Dried extract of Ginkgo Biloba 68 Meclizine HCl+ Paracetamol + Caffeine 69 Nicergoline + Vinpocetine 70 Gamma Linolenic Acid + Methylcobalamin 71 Beclomethasone Dipropionate + Neomycin Sulphate + Clotrimazole + Lignocaine HCl 72 Boric acid+ Phenylephrine HCl + Naphazoline Nitrate + Menthol + Camphor 73 Naphazoline HCl + Chlorpheniramine Maleate + Zinc Sulphate + Hydroxy Propyl Methyl Cellulose 74 Chlorpheniramine Maleate + Naphazoline HCl + Zinc Sulphate + Sodium Chloride + Hydroxy Propyl Methyl Cellulose 75 Chlorpheniramine Maleate + Naphazoline HCl + Hydroxy Propyl Methyl Cellulose 76 Chlorpheniramine Maleate + Sodium Chloride + Boric Acid + Tetrahydrozoline HCl 77 Chlorpheniramine Maleate + Phenylephrine HCl + Antipyrine 78 Ketorolac Tromethamine + Chlorpheniramine Maleate + Phenylephrine HCl + Hydroxy Propyl Methyl Cellulose 79 Ketorolac Tromethamine + Flurometholone 80 Naphazoline HCl + Zinc Sulphate + Boric Acid + Sodium Chloride+ Chlorpheniramine Maleate 81 Naphazoline HCl + Hydroxy Propyl Methyl Cellulose + Boric Acid + Borax + Menthol + Camphor 82 Naphazoline HCl + Hydroxy Propyl Methyl Cellulose + Chlorpheniramine Maleate SN Fixed Dose Combination (FDC) 83 Diphenhydramine Hydrochloride + Phenylephrine Hydrochloride + Menthol + Camphor 84 Diphenhydramine Hydrochloride + Phenylephrine Hydrochloride + Sodium Chloride + Hydroxy Propyl Methyl Cellulose 85 Diphenhydramine Hydrochloride + Phenylephrine Hydrochloride + Sodium Chloride + Methylparaben 86 Methenamine + Sodium Benzoate + Benzyl Alcohol 87 Paracetamol + Phenylephrine Hydrochloride + Chlorpheniramine Maleate 88 Paracetamol + Phenylephrine Hydrochloride + Chlorpheniramine Maleate + Caffeine 89 Propoxyphene + Chlorpheniramine Maleate 90 Propoxyphene + Phenylephrine Hydrochloride + Chlorpheniramine Maleate 91 Propoxyphene + Diphenhydramine Hydrochloride + Phenylephrine Hydrochloride 92 Sodium Benzoate + Sodium Citrate + Citric Acid 93 Vitamin A Palmitate + Vitamin C + Vitamin E + Vitamin B6 + Vitamin B12 94 Vitamin A Palmitate + Vitamin C + Vitamin E + Niacinamide 95 Vitamin B6 + Vitamin B12 + Vitamin C 96 Vitamin B6 + Vitamin B12 + Niacinamide 97 Vitamin B12 + Vitamin B6 + Vitamin C + Folic Acid 98 Vitamin B12 + Vitamin B6 + Niacinamide + Folic Acid 99 Vitamin C + Vitamin E + Vitamin A + Niacinamide 100 Vitamin D + Calcium + Magnesium 101 Vitamin D + Calcium + Magnesium + Zinc 102 Calcium + Vitamin D + Vitamin K 103 Calcium + Vitamin D + Magnesium + Zinc 104 Calcium + Vitamin D + Vitamin K + Magnesium 105 Calcium + Vitamin D + Vitamin K + Magnesium + Zinc 106 Vitamin E + Vitamin A + Vitamin C + Niacinamide 107 Vitamin E + Vitamin A + Vitamin C + Folic Acid 108 Vitamin E + Vitamin A + Vitamin C + Biotin 109 Vitamin E + Vitamin A + Vitamin C + Vitamin B12 110 Vitamin E + Vitamin C + Folic Acid 111 Vitamin E + Vitamin C + Biotin 112 Vitamin E + Vitamin C + Vitamin B12 113 Vitamin E + Vitamin C + Zinc 114 Calcium + Vitamin D + Omega-3 Fatty Acids 115 Calcium + Vitamin D + Omega-3 Fatty Acids + Vitamin K 116 Calcium + Vitamin D + Omega-3 Fatty Acids + Vitamin K + Magnesium 117 Calcium + Vitamin D + Omega-3 Fatty Acids + Vitamin K + Zinc 118 Vitamin A + Vitamin C + Vitamin E + Beta-Carotene 119 Vitamin A + Vitamin C + Vitamin E + Beta-Carotene + Zinc 120 Vitamin C + Vitamin E + Beta-Carotene 121 Vitamin C + Vitamin E + Beta-Carotene + Zinc 122 Vitamin C + Vitamin E + Selenium 123 Vitamin D + Calcium + Vitamin K + Omega-3 Fatty Acids 124 Vitamin D + Calcium + Vitamin K + Omega-3 Fatty Acids + Magnesium 125 Vitamin D + Calcium + Vitamin K + Omega-3 Fatty Acids + Zinc 126 Vitamin D + Calcium + Vitamin K + Omega-3 Fatty Acids + Biotin 127 Vitamin D + Calcium + Omega-3 Fatty Acids + Vitamin K + Selenium 128 Vitamin E + Vitamin A + Vitamin C + Zinc 129 Vitamin E + Vitamin A + Vitamin C + Selenium 130 Vitamin E + Vitamin A + Vitamin C + Biotin 131 Vitamin E + Vitamin A + Vitamin C + Folic Acid + Niacinamide 132 Vitamin E + Vitamin C + Beta-Carotene + Zinc 133 Vitamin C + Vitamin E + Biotin + Folic Acid 134 Vitamin C + Vitamin E + Beta-Carotene + Folic Acid 135 Vitamin C + Vitamin E + Beta-Carotene + Selenium 136 Vitamin E + Vitamin C + Beta-Carotene + Biotin 137 Vitamin D + Calcium + Omega-3 Fatty Acids + Vitamin K + Biotin 138 Vitamin D + Calcium + Omega-3 Fatty Acids + Vitamin K + Selenium 139 Vitamin D + Calcium + Omega-3 Fatty Acids + Vitamin K + Vitamin B12 140 Vitamin D + Calcium + Omega-3 Fatty Acids + Vitamin K + Vitamin B6 141 Vitamin D + Calcium + Omega-3 Fatty Acids + Vitamin K + Folate 142 Calcium + Vitamin D + Magnesium + Vitamin K + Omega-3 Fatty Acids 143 Calcium + Vitamin D + Magnesium + Vitamin K + Biotin 144 Calcium + Vitamin D + Magnesium + Vitamin K + Selenium 145 Calcium + Vitamin D + Magnesium + Vitamin K + Vitamin B12 146 Calcium + Vitamin D + Magnesium + Vitamin K + Folate 147 Calcium + Vitamin D + Vitamin K + Omega-3 Fatty Acids + Vitamin B6 148 Calcium + Vitamin D + Vitamin K + Omega-3 Fatty Acids + Vitamin B12 149 Calcium + Vitamin D + Vitamin K + Omega-3 Fatty Acids + Folic Acid 150 Calcium + Vitamin D + Vitamin K + Omega-3 Fatty Acids + Biotin 151 Calcium + Vitamin D + Vitamin K + Omega-3 Fatty Acids + Selenium 152 Vitamin A + Vitamin C + Vitamin E + Omega-3 Fatty Acids 153 Vitamin A + Vitamin C + Vitamin E + Omega-3 Fatty Acids + Zinc 154 Vitamin A + Vitamin C + Vitamin E + Omega-3 Fatty Acids + Biotin 155 Vitamin A + Vitamin C + Vitamin E + Omega-3 Fatty Acids + Selenium 156 Vitamin A + Vitamin C + Vitamin E + Omega-3 Fatty Acids + Vitamin B12

Drug Approval

100 Deals associated with Beclometasone Dipropionate

External Link

KEGG	Wiki	ATC	Drug Bank
D00689	Beclometasone Dipropionate	D07AC15 R03BA01 R01AD01	DB00394

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Rhinitis, Allergic, Seasonal	United States	Teva Branded Pharmaceutical Products R&D LLC	23 Mar 2012
Rhinitis, Vasomotor	Japan	Sumitomo Pharmaceuticals Co., Ltd.	01 Oct 1999
Asthma	United States	Schering Corp.	12 May 1976
Rhinitis, Allergic	United States	Schering Corp.	12 May 1976

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Airway Obstruction	Phase 3	United Kingdom	CHIESI Farmaceutici SpA	20 Jan 2015
Dyspnea	Phase 3	United Kingdom	CHIESI Farmaceutici SpA	20 Jan 2015
Acute sinusitis	Phase 3	Italy	CHIESI Farmaceutici SpA	01 Jan 2013
Obstructive bronchitis	Phase 3	Italy	CHIESI Farmaceutici SpA	07 Aug 2012
Pneumonia	Phase 3	Italy	CHIESI Farmaceutici SpA	07 Aug 2012
Mediastinal Diseases	Phase 3	Italy	CHIESI Farmaceutici SpA	31 May 2012
Chronic lung disease	Phase 3	Netherlands	CHIESI Farmaceutici SpA	18 May 2011
Croup	Phase 3	Italy	CHIESI Farmaceutici SpA	01 Apr 2010
Acute Graft Versus Host Disease	Phase 3	United States	Soligenix, Inc.	01 Oct 2009
Rhinitis, Allergic, Perennial	Phase 3	United States	Teva Pharmaceutical Industries Ltd.	01 Oct 2009

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05292586 (FORCE2, Pubmed \| J Asthma)	Phase 3	Asthma	543	beclomethasone/formoterol	fsmkoqoreo(vqfmauutkp) = zozwzboppo yeudqooipa (egkkwpzoan )	Positive	22 Nov 2025
				beclomethasone	fsmkoqoreo(vqfmauutkp) = dmfsghcchf yeudqooipa (egkkwpzoan )
NCT04294641 (CTgov)	Phase 2	Chronic graft-versus-host disease	10	Ibrutinib	utimrbfbrr = henxaoqpyk fadfoxempq (blldcnhbey, wdniymfswf - dmuaanayxv) View more	-	22 Jan 2025
NCT03886441 (ESMO2024) Manual	Phase 2	Locally Advanced Lung Non-Small Cell Carcinoma	292	Belomethason propionate inhalation	belqqowhbo(jiypygpzjv) = xjlbxodcyt nwhnduqezz (wlvsfsabnh ) View more	Positive	16 Sep 2024
				belomethason propionate inhalation (Control (no inhalation))	belqqowhbo(jiypygpzjv) = bclmxbrvoi nwhnduqezz (wlvsfsabnh ) View more
NCT02517099 (PrIGMa, CTgov)	Phase 2	Asthma \| Inflammation \| Infectious Diseases	60	Beclometasone+Azithromycin+Co-amoxiclav (Pathological Phenotype)	aiwjhmpycj(jaoxztxmmx) = eyeaftsyhi lkogadibsd (mumzsuxgcl, xnbabahard - oofaogtazw) View more	-	06 Mar 2023
				Beclometasone+Azithromycin+Co-amoxiclav (Clinical Guidelines)	aiwjhmpycj(jaoxztxmmx) = avdlryiwsu lkogadibsd (mumzsuxgcl, qbgrvaixne - jwdrspqjhx) View more
NCT02351180 (CTgov)	Phase 1/2	Lung transplant rejection \| Viral respiratory infection	16	Inhaled beclomethasone (Inhaled Beclomethasone)	hehzywdeft = uucywkmzsz aaeqaawrrs (xjfxyteotv, nyivymewkj - scqblhsgbc) View more	-	03 Mar 2022
				Placebo (Placebo)	hehzywdeft = zqhqvyuhlc aaeqaawrrs (xjfxyteotv, hxzufnojdr - gsynjuhgwo) View more
NCT03084718 (BEAM, CTgov)	Phase 2	Asthma	610	CHF (Treatment A (CHF 718 pMDI 100 µg TDD))	jnpfibqkqp(hnhwaonmjy) = mfvywlufbi upcnwcixnk (dadqaolbli, lnvdjhexqm - rtkfhuqiyt) View more	-	14 Dec 2021
				CHF (Treatment B (CHF 718 pMDI 400 µg TDD))	jnpfibqkqp(hnhwaonmjy) = apbecbupuj upcnwcixnk (dadqaolbli, yxsdjnswdn - gxtmmpdckb) View more
NCT01852513 (CTgov)	Phase 4	Rhinitis, Allergic, Seasonal	39	QNASL (QNASL Nasal Spray)	tzcnldwiqi(ybhqgbaoqo) = svxgowvuse sudtijiduy (kulesbniqt, 43.2) View more	-	09 Oct 2020
				Placebo nasal spray (Placebo Nasal Spray)	tzcnldwiqi(ybhqgbaoqo) = manfduzfgl sudtijiduy (kulesbniqt, 34.3) View more
NCT02499887 (CTgov)	Not Applicable	Pulmonary Disease, Chronic Obstructive \| Asthma	6	prednisone+albuterol (Standard of Care)	imxdsvmbgi(lihijkdtcl) = bxfswnpzaw nsxelrnhzi (tjflbgtlnu, wzzotjgncv - sbzflmwoaf) View more	-	04 Jun 2019
				beclamethasone dipropionate+prednisone+albuterol (Treatment)	imxdsvmbgi(lihijkdtcl) = twkylviyoe nsxelrnhzi (tjflbgtlnu, qeuniyrmcy - pvpbnjlqzo) View more
NCT01142947 (SAPPHIRE, CTgov)	Not Applicable	Asthma	362	beclomethasone dipropionate	vpsstwqkrl(uwwsfztltf) = pzcfoscttt gkbnxtqeyj (ctpkjvcsvc, 4.47) View more	-	02 Apr 2019
NCT01925950 (CTgov)	Phase 2	Signs and Symptoms, Digestive \| Chronic graft-versus-host disease \| Gastrointestinal Diseases	2	Placebo (Placebo)	kqkksdwxah = oxgzkuxsnh obvbbfphmn (uydohxopsu, wpwwebckoa - gqabfebfjb) View more	-	04 Oct 2018
				orBec (orBec)	kqkksdwxah = ahigzmpluf obvbbfphmn (uydohxopsu, frqdvcxikd - vmzasdlmow) View more

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Beclometasone Dipropionate

Overview

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