A Single Dose, Fasting state, Crossover Replicate Bioequivalence Study of Naproxen 500 mg/Esomeprazole 20 mg, modified-release tablets (Antibiotice S.A.) vs. Vimovo® 500 mg/20 mg film-coated tablets (Grunenthal Gmbh)

Start Date31 Oct 2024

Sponsor / Collaborator-

CTIS2023-508621-27-00

/ CompletedPhase 1

A Single Dose, Fed state, Crossover Replicate, Bioequivalence Study of Naproxen 500 mg/ Esomeprazole 20 mg modified-release tablets (Antibiotice S.A.) versus Vimovo® 500 mg/20 mg film coated tablets (Grunenthal GmbH)

Start Date05 Mar 2024

Sponsor / Collaborator-

NCT03092193

/ CompletedPhase 4IIT

Clinical Pharmacokinetics of Cytochrome P450: Influence on the Pharmacokinetics of Naproxen (CYP2C8 and CYP2C9) and Associated Naproxen-esomeprazole (CYP2C19)

The family of cytochrome P450 (CYP) is the most important drug metabolizing enzymes which contributes to the metabolism of a large proportion of drugs in humans. Some CYP450 enzymes reduce or alter the pharmacodynamic activity of many drugs and are involved in oxidative metabolism and elimination of many drugs commonly used by the population. Polymorphisms in CYP2C8 and CYP2C9 are common in different populations around the world and genetic variations in these alleles can cause decreased enzyme activity to nonsteroidal anti-inflammatory drugs (NSAIDs) such as celecoxib, diclofenac, ibuprofen, indomethacin, lornoxicam, meloxicam, valdecoxib, piroxicam, tenoxicam and naproxen. This compromise the bioavailability of the drug can alter the pharmacokinetics of these drugs and patients with mutations in these genes can exhibit increased plasma concentrations of values and areas under the curve (AUC), in addition to decreased clearance of drugs. Associations between NSAIDs and gastric protectors or proton pump inhibitors (PPIs) have become common nowadays, especially in patients who make chronic use of these drugs. Naproxen associated to esomeprazole, a proton pump inhibitor (PPI), was launched in the market recently and its application in acute pain is not yet elucidated. Esomeprazole suffers strong influence of CYP2C19 (hepatic drug-metabolizing enzyme that degrades PPIs). In patients with high enzyme activity of the CYP2C19, the drug can suffer high enzymatic degradation, and its diminished effect. Moreover, in patients with low enzyme CYP2C19 activity, the effect of acid inhibition by PPIs can be very strong.

Start Date01 Mar 2017

Sponsor / Collaborator

University of Sao Paulo

[+1]

100 Clinical Results associated with Esomeprazole Magnesium/Naproxen

100 Translational Medicine associated with Esomeprazole Magnesium/Naproxen

100 Patents (Medical) associated with Esomeprazole Magnesium/Naproxen

Literatures (Medical) associated with Esomeprazole Magnesium/Naproxen

01 Dec 2018·Pediatric rheumatology online journalQ3 · MEDICINE

A 6-month, multicenter, open-label study of fixed dose naproxen/esomeprazole in adolescent patients with juvenile idiopathic arthritis

Q3 · MEDICINE

ArticleOA

Author: Lovell, Daniel J ; Jerath, Rita ; Von Scheven, Emily ; Francis-Sedlak, Megan ; Alpan, Oral ; Naddaf, Henry ; Reinhardt, Adam ; Dare, Jason A ; Zeft, Andrew ; Jung, Lawrence ; LaMoreaux, Brian D ; Gottlieb, Beth ; Goldsmith, Donald ; Holt, Robert J ; Ball, Julie ; Gupta, Ramesh

BACKGROUND:

Juvenile idiopathic arthritis (JIA) is an inflammatory arthritis of unknown etiology, which lasts for greater than 6 weeks with onset before 16 years of age. JIA is the most common chronic rheumatic disease in children. NSAIDs have been the mainstay of initial management with naproxen (NAP) being commonly used, but they may cause serious side effects such as gastric ulcers which can be reduced by concomitant administration of proton pump inhibitors, such as esomeprazole (ESO).

METHODS:

Primary objective was to evaluate the safety and tolerability of 3 fixed doses of NAP/ESO in JIA patients aged 12 to 16 years. Forty-six children and adolescents with JIA by International League of Associations for Rheumatology criteria, mean age of 13.6 years, from 18 US sites were prospectively enrolled over 2 years and followed for up to 6 months. Doses of the NAP/ESO fixed combination were based on baseline weight. The exploratory efficacy outcome was assessed with the ACR Pediatric-30, - 50, - 70, - 90 Response and the Childhood Health Assessment Questionnaire (CHAQ) discomfort and functional scores at months 1, 3, and 6 as change from baseline. Occurrence and causality were assessed for treatment emergent AEs (TEAEs) and discontinuations were monitored monthly.

RESULTS:

Forty-six patients received at least 1 dose of naproxen/esomeprazole and 36 completed the trial. Thirty-seven (80.4%) had at least 1 treatment emergent adverse event (TEAE) and, with the exception of 2 events in one patient, all of the TEAEs were mild or moderate. Frequent TEAEs (≥5% of patients) were upper respiratory tract and gastrointestinal related. Eleven (23.9%) had at least 1 TEAE considered to be related to study drug. Four patients (8.7%) discontinued due to a TEAE with one of these being the only serious AE reported, acute hepatitis. Mean number of active joints at baseline was 3.1. Improvement in JIA signs and symptoms occurred at most assessments and by month 6, the percentage of patients with an ACR Pediatric-30, - 50, - 70, and - 90 Response was 47.1, 38.2, 32.4, and 17.6%, respectively. The percent of patients achieving ACR Pediatric response increased over time. CHAQ discomfort improved at each assessment and functional scores improved at all assessments for 'Arising, Walking, and Activities' with several improved for 'Dressing and Grooming, Eating, Hygiene, and Grip'. There was no indication of a dose-related efficacy effect.

CONCLUSION:

NAP/ESO was well tolerated in JIA patients aged 12 to 16 years with high levels of response to ACR criteria. No new safety signals were identified for the well-characterized components of this fixed dosed JIA treatment, which was developed to reduce the risk of gastric ulcers.

TRIAL REGISTRATION:

Clinicaltrials.gov, NCT01544114 . Registered February 21, 2012.

01 Sep 2016·Drug development and industrial pharmacyQ4 · MEDICINE

Novel naproxen/esomeprazole magnesium compound pellets based on acid-independent mechanism:in vitroandin vivoevaluation

Q4 · MEDICINE

Article

Author: Kan, Shuling ; Lu, Jing ; Zhao, Yi ; Liu, Jianping ; Zhang, Wenli

The purpose of this study was to develop the novel naproxen/esomeprazole magnesium compound pellets (novel-NAP/EMZ) depending on EMZ acid-independent mechanism which has been proved to be predominate in the mechanism of co-therapy with nonsteroidal anti-inflammatory drug. The novel-NAP/EMZ compound pellets, composed of NAP colon-specific pellets (NAP-CSPs) and EMZ modified-release pellets (EMZ-MRPs), were prepared by fluid-bed coating technology with desired in vitro release profiles. The resulting pellets were filled into hard gelatin capsules for in vivo evaluation in rats and compared with the reference compound pellets, consisted of NAP enteric-coated pellets (NAP-ECPs) and EMZ immediate-release pellets (EMZ-IRPs). The reference compound pellets were prepared simulating the drug delivery system of VIMOVO(®). In vivo pharmacokinetics, EMZ-MRPs had significantly larger AUC0-t (p < 0.01), 1.67 times more than that of EMZ-IRPs, and prolonged mean residence time (7.55 ± 0.12 h) than that of IRPs (1.46 ± 0.39 h). NAP-CSPs and NAP-ECPs showed similar AUC0-t. Compared to the reference compound pellets, the novel-NAP/EMZ compound pellets did not show distinct differences in histological mucosal morphology. However, biochemical tests exhibited enhanced total antioxidant capacity, increased nitric oxide content and reduced malondialdehyde level for novel-NAP/EMZ compound pellets, indicating that the acid-independent action took effect. The gastric pH values of novel-NAP/EMZ compound pellets were at a low and stable level, which could ensure normal physiological range of human gastric pH. As a result, the novel-NAP/EMZ compound pellets may be a more suitable formulation with potential advantages by improving bioavailability of drug and further reducing undesirable gastrointestinal damages.

01 Apr 2014·ChiralityQ4 · CHEMISTRY

Single Enantiomer Versus Racemate: Chiral Distinction in the Proton Pump Inhibitors Omeprazole and Esomeprazole

Q4 · CHEMISTRY

Article

Author: Pogodin, Sergey ; Agranat, Israel ; Marom, Hili

ABSTRACT:

Chiral distinction in the proton pump inhibitor drugs omeprazole and in its chiral‐switch esomeprazole magnesium was studied employing the Density Functional Theory (DFT) method. At B3LYP/6‐311G(d,p), the 6‐methoxy∙∙∙6‐methoxy and 5‐methoxy∙∙∙5‐methoxy homochiral and heterochiral dimers were calculated. The chiral distinction free energies (ΔΔG298,(RS‐SS)) between the cyclicC2‐(S,S)‐ andCi‐(R,S)‐dimers with two intermolecular hydrogen bonds are 3.8, 1.9 (with BSSE counterpoise correction), and –6.9 (with D3 dispersion and BSSE counterpoise corrections) kJ/mol. Adding water as an implicit solvent (polarized continuum model [PCM] model) resulted in a chiral distinction energy of –3.3 kJ/mol, indicating a reversal of the order of the relative stabilities ofC2‐(S,S)‐ andCi‐(R,S)‐dimers. The chiral distinction free energies between the corresponding (less stable)C1‐dimers with one intermolecular hydrogen bond are –9.3, –5.8 (with BSSE CC), 17.6 (D3 + BSSE CC), and –3.2 (H2O) kJ/mol. The results highlight the contention that omeprazole is not just a superposition of its enantiomer constituents. They are consistent with the pharmacological evidence of enantiomer–enantiomer interactions in omeprazole versus esomeprazole and the differences between the drugs omeprazole and esomeprazole magnesium and support the lodged application for regulatory supplementary protection certificate (SPC) exclusivity for the esomeprazole‐related combination drug Vimovo.Chirality 26:214–227, 2014.© 2014 Wiley Periodicals, Inc.

News (Medical) associated with Esomeprazole Magnesium/Naproxen

28 Sep 2026

·www.prnewswire.com

Grünenthal partners with DKSH to bring four important pain medicines to eight new markets in Asia-Pacific

The partnership will bring Qutenza ®, Vimovo ®, Palexia®and Zomig® to people living with pain in Asia-Pacific, spanning Hong Kong, Indonesia, Malaysia, Philippines, Singapore, Taiwan, Thailand and Vietnam. *Pain is a significant healthcare challenge in the region, due to the ageing population and the high burden of chronic diseases.[1],[2], [3] The partnership is a key step in Grünenthal's strategy to enhance patient care and expand access to its innovative medicines. AACHEN, Germany, Sept. 28, 2026 /PRNewswire/ -- Grünenthal, a global leader in pain management and research, and DKSH Business Unit Healthcare, a strategic healthcare business partner and leading provider of Market Expansion Services for pharmaceutical, over-the-counter (OTC), consumer health and medical device companies, today announced a new partnership agreement to bring four Grünenthal medicines, Qutenza®, Vimovo®, Palexia® and Zomig®, to Asia-Pacific, accelerating access to innovative pain therapies in the region. The partnership will support the availability of Grünenthal's pain medicines across eight markets in Asia-Pacific: Hong Kong, Indonesia, Malaysia, Philippines, Singapore, Taiwan, Thailand and Vietnam, bringing up to four new medicines to patients in each market, pending local regulatory approvals. Under the agreement, DKSH will commercialise the medicines on Grünenthal's behalf across the eight markets, being responsible for seeking local marketing authorisations and the activities of marketing, medical, market access, sales and distribution. Grünenthal will manufacture the medicines through its integrated global manufacturing network. "Qutenza®, Vimovo®, Palexia® and Zomig® have delivered meaningful benefits to millions of people living with pain worldwide. Through our partnership with DKSH, we are taking another significant step toward broadening access to proven therapies and extending the reach of our medicines to more patients who need them," said Jan Adams, Chief Commercial Officer, Grünenthal. "With pain affecting potentially hundreds of millions across Asia-Pacific, new care options that meet the broad spectrum of patient needs are critical. We are proud to join forces with DKSH to help improve lives and advance our vision of a World Free of Pain." "This partnership marks another important milestone in DKSH Healthcare's new chapter of growth. Grünenthal is a globally recognised leader in pain management, and we are proud to further strengthen our relationship through an expanded alliance partnership spanning eight markets across Asia-Pacific. Leveraging our Regional Partnership model and integrated end-to-end commercialisation platform, we are well positioned to accelerate growth, improve access to innovative therapies for patients across the region, and advance our mission of delivering Healthcare for All," said Patrik Grande, Global Head of Business Unit Healthcare, DKSH. Pain is a significant healthcare challenge in Asia-Pacific, due to the ageing population and the high burden of chronic diseases.1,2,3 Hundreds of millions of people in the region may be living with chronic pain, based on population figures and global estimates of chronic pain prevalence.2,3 Grünenthal and DKSH first established their partnership in 2023, when DKSH took over the commercialisation of the already established medicines Nebido®, Zomig® and Tramal® in selected Asia-Pacific markets. Under the new agreement, DKSH will now seek local marketing authorisations for Qutenza®, Vimovo®, Palexia® and Zomig® across the eight participating markets, with Zomig® being introduced in additional markets not covered by the 2023 agreement. About Qutenza® In Europe, Qutenza® is indicated for the treatment of peripheral neuropathic pain in adults, either alone or in combination with other medicinal products for the treatment of pain. Qutenza® (capsaicin) 8% topical system is approved in the US for the treatment of neuropathic pain associated with postherpetic neuralgia and for the treatment of neuropathic pain associated with diabetic peripheral neuropathy (DPN) of the feet in adults. Important US safety information is available at . About Vimovo ® Vimovo® (fixed-dose combination of esomeprazole and naproxen) is indicated in adults for the symptomatic treatment of osteoarthritis, rheumatoid arthritis and ankylosing spondylitis, in patients who are at risk for developing non-steroidal anti-inflammatory drug (NSAID)-associated gastric and/or duodenal ulcers and where treatment with lower doses of naproxen or of other NSAIDs is not considered sufficient. About Zomig ® Zomig® (zolmitriptan) is indicated as an oral formulation in adults aged 18 years and older for acute treatment of migraine headache with or without aura, and as a nasal spray in adults and adolescents aged 12 years and older for the acute treatment of migraine headache with or without aura and in adults for the acute treatment of cluster headache. About Palexia ® Palexia® (tapentadol) is indicated as a prolonged-release tablet for the management of severe chronic pain in adults which can be adequately managed only with opioid analgesics, and for the management of severe chronic pain in children above 6 years and adolescents, which can be adequately managed only with opioid analgesics. It is also indicated as a film-coated IR tablet for the relief of moderate to severe acute pain in adults which can be adequately managed only with opioid analgesic, and as an oral solution for the relief of moderate to severe acute pain in children* and adolescents from 2 years of age and in adults which can be adequately managed only with opioid analgesics. *in children restricted to hospital use where appropriate equipment to enable respiratory support is available. As with all symptomatic treatments, the continued use of tapentadol exceeding 3 days must be evaluated on an ongoing basis. Statement on the responsible use of opioids General considerations for the management of pain with any medication that contains an opioid mechanism of action. All opioid medications are not authorised for all types of pain indication. Always refer to the product prescribing information. An individualised, patient-centred approach for the diagnosis and treatment of pain is essential to establish a therapeutic alliance between patient and clinician. To optimise opioid treatment: It is important to optimally use multimodal, non-opioid approaches in acute and chronic pain before escalating to opioids or in conjunction with opioid therapy. Opioids should be used only when benefits for pain and function are expected to outweigh risks. Consider patient variables that may affect opioid dose for each patient prior to opioid use. During ongoing opioid therapy, clinicians should collaborate with patients to evaluate and carefully weigh benefits and risks of continuing opioid therapy and exercise care when increasing, continuing, or reducing opioid dosage. Make a careful selection of patients, abuse risk factors evaluated, and regular monitoring and follow-up implemented to ensure that opioids are used appropriately and in alignment with treatment goals (pain intensity and functionality) as agreed with the patient. Make patients aware of the potential side effects of opioids and the potential for developing tolerance, dependence and addiction. Addiction is possible even when opioids are taken as directed. Signs of opioid use disorder should be monitored and addressed. If an opioid is authorised and selected for treatment of acute pain, please consider: The use should be for the shortest necessary time. If an opioid is authorised and selected for treatment of chronic pain, please consider: To continue opioid therapy only if there is clinically meaningful improvement in pain and function that outweighs risks to patient safety. Regular monitoring, clinical reviews, re-evaluations are required for long-term opioid treatment to assess pain control, impact on lifestyle, physical and psychological well-being, side effects and continued need for treatment. How opioid therapy will be discontinued if benefits do not outweigh risks (CDC new ref), incl. tapering down the dose where possible. Patients and the general public can benefit from clear educational materials and awareness interventions to support the responsible use of opioids. About DKSH For more than 160 years, DKSH has been delivering growth for companies in Asia Pacific, Europe, and North America across its Business Units Healthcare, Consumer Goods, Performance Materials, and Technology. As a leading Market Expansion Services provider, DKSH offers sourcing, market insights, marketing and sales, e-commerce, distribution and logistics as well as after-sales services, following its purpose of enriching people's lives. DKSH is a participant of the United Nations Global Compact and adheres to its principles-based approach to responsible business. Listed on the SIX Swiss Exchange, DKSH operates in 35 markets with 26,840 specialists, generating net sales of CHF 11.1 billion in 2025. DKSH Business Unit Healthcare distributes pharmaceuticals, consumer health, over-the-counter products and medical devices. With around 7,580 specialists, the Business Unit generated net sales of CHF 5.8 billion in 2025. About Grünenthal Grünenthal is a global leader in pain management and related diseases. As a science-based, fully integrated pharmaceutical company, we have a long track record of bringing innovative treatments and state-of-the-art technologies to patients worldwide. Our purpose is to change lives for the better – and innovation is our passion. We focus all our activities and efforts on working towards our vision of a World Free of Pain. Grünenthal is headquartered in Aachen, Germany, and has affiliates in 28 countries across Europe, Latin America, and the U.S. Our products are available in approx. 100 countries. In 2025, Grünenthal employed around 4,100 people and achieved revenues of €1.8 billion. More information: Follow us on LinkedIn & Instagram For further information, please contact: Matt Crabb, Head of Global Communications (Interim) at Grünenthal [email protected] References [1] Vallath N, et al. Access to pain relief and essential opioids in the WHO South-East Asia Region: challenges in implementing drug reforms. WHO South-East Asia Journal of Public Health. 2018; 7(2). Available at: . Accessed September 2026. [2] The Lancet Regional Health – Western Pacific. Chronic pain in Asia: we don't have to endure. Lancet Reg Health West Pac. 2023; 33:100782. Available at: . Accessed September 2026. [3] World Health Organization. WHO South-East Asia Regional Strategy on Healthy Ageing 2024–2030. Available at: . Accessed September 2026. SOURCE Grünenthal Group 21% more press release views with Request a Demo

Drug ApprovalLicense out/in

21 Sep 2026

·www.prnewswire.com

Grünenthal acquires cancer treatment Stivarga®

Latest step in Grünenthal's strategy to acquire established medicines that serve clear medical needs, leverage its commercial and operational capabilities, and drive growth. Stivarga® (regorafenib) is an established oral treatment for certain advanced cancers, including metastatic colorectal cancer, gastrointestinal stromal tumours (GIST) and hepatocellular carcinoma (liver cancer). It is approved and available in more than 90 markets worldwide. Grünenthal has invested around €2.6 billion in successful M&A transactions since 2017, significantly strengthening its profitability and further funding its innovative research pipeline. AACHEN, Germany, Sept. 21, 2026 /PRNewswire/ -- Grünenthal, a global leader in pain management and research, today announced an agreement with Bayer AG to acquire Stivarga®, an oral treatment for specific advanced cancers, for up to €375 million. The acquisition is subject to customary closing conditions, including approval by the relevant regulatory authorities. The acquisition is expected to close by the end of 2026 or early 2027. Stivarga® (regorafenib) is an oral multkinase inhibitor indicated for metastatic colorectal cancer, hepatocellular carcinoma and gastrointestinal stromal tumours (GIST) in patients who have already been treated with, or who cannot be given, other available treatments. It is approved and available in more than 90 markets worldwide. "This acquisition is a strong strategic fit for Grünenthal and reflects our disciplined M&A strategy of acquiring established medicines that address clear and ongoing medical needs and create long-term value," said Gabriel Baertschi, CEO, Grünenthal. "Stivarga® has a well-established role in patient care and the transaction is immediately accretive to our business. By leveraging the strength of our commercial and operational expertise, we see clear opportunities to maximise the value of the medicine and support Grünenthal's long-term growth." Loss of exclusivity for Stivarga® is anticipated in 2029 in the European Union and in 2030 in the United States (US). Grünenthal estimates that Stivarga® may contribute a positive impact on its consolidated EBITDA of up to approximately €100 million for the year ending 31 December 2027, based on an analysis of the information made available to Grünenthal from Bayer and assuming closing by the end of 2026 or the beginning of 2027, as well as a full-year consolidation. The acquisition is the latest development in Grünenthal's M&A strategy and follows the successful integration of several important medicines across a range of health conditions, including the global rights to Nebido™, the rights to Cialis® in Mexico, Brazil and Colombia, the European rights to Crestor™ and Nexium™, and the global rights to Vimovo™ (ex-US and Japan), Zomig™ (ex-Japan) and Qutenza™. In addition to asset acquisitions, earlier this year, Grünenthal acquired full ownership of Grünenthal Meds, a previously joint venture with Kyowa Kirin International to market its established medicines portfolio, and, in 2024, acquired the US company Valinor Pharma and the product Movantik®. The company has invested around €2.6 billion in successful M&A transactions since 2017. About Stivarga ® Stivarga® is a once-daily, oral prescription medicine for certain advanced cancers. It has treated more than one million patients across more than 90 countries over 10 years. In the EU, Stivarga® is indicated as monotherapy for the treatment of adult patients with metastatic colorectal cancer (mCRC) who have been previously treated with, or are not considered candidates for, available therapies including fluoropyrimidine-based chemotherapy, an anti-VEGF therapy and an anti-EGFR therapy, as well as for the treatment of adult patients with unresectable or metastatic gastrointestinal stromal tumor (GIST) who progressed on or are intolerant to prior treatment with imatinib and sunitinib, and for the treatment of adult patients with hepatocellular carcinoma (HCC) who have been previously treated with sorafenib. In the US, Stivarga® is indicated for the treatment of patients with mCRC who have been previously treated with fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy, an anti-VEGF therapy, and, if RAS wild-type, an anti-EGFR therapy, as well as locally advanced, unresectable or metastatic GIST who have been previously treated with imatinib mesylate and sunitinib malate, and for HCC who have been previously treated with sorafenib. About Grünenthal Grünenthal is a global leader in pain management and related diseases. As a science-based, fully integrated pharmaceutical company, we have a long track record of bringing innovative treatments and state-of-the-art technologies to patients worldwide. Our purpose is to change lives for the better – and innovation is our passion. We focus all our activities and efforts on working towards our vision of a World Free of Pain. Grünenthal is headquartered in Aachen, Germany, and has affiliates in 28 countries across Europe, Latin America, and the U.S. Our products are available in approx. 100 countries. In 2025, Grünenthal employed around 4,100 people and achieved revenues of €1.8 billion. More information: Follow us on LinkedIn & Instagram Advisors Freshfields served as legal counsel to Grünenthal. For further information, please contact: Matt Crabb, Head of Global Communications (Interim), Grünenthal [email protected] SOURCE Grünenthal Group 21% more press release views with Request a Demo

AcquisitionDrug Approval

02 Jun 2025

·www.prnewswire.com

Grünenthal announces acquisition of the rights to Cialis® from Lilly in Mexico, Brazil & Colombia

Grünenthal announces that it agreed to acquire the commercial rights to Cialis® from Eli Lilly and Company in Mexico, Brazil and Colombia, further strengthening Grünenthal's footprint in Latin America. As part of the acquisition, Grünenthal will transfer the manufacturing of Cialis® to its production site in Chile. Since 2017, Grünenthal has invested more than €2 billion in successful M&A transactions, significantly strengthening its profitability. AACHEN, Germany, June 2, 2025 /PRNewswire/ -- Grünenthal today announced the acquisition of the commercial rights to Cialis® (tadalafil) in Mexico, Brazil and Colombia from Eli Lilly and Company. Over the next few years, Grünenthal and Lilly will work together to transfer the manufacturing to Grünenthal's production site in Santiago, Chile, that will supply Cialis® for Mexico, Brazil and Colombia moving forward. The transaction is expected to close in the third quarter of 2025, subject to the satisfaction of customary closing conditions. Grünenthal will finance the transaction using available liquidity. The financial terms of the transaction are not disclosed. Cialis® is indicated for the oral treatment of erectile dysfunction and signs and symptoms of benign prostatic hyperplasia in adult men[1]. The acquisition will expand Grünenthal's Latin American Men's Health product portfolio. "Executing on our strategy of targeted acquisitions, Cialis® will expand our existing portfolio in the region and strengthen Grünenthal's Latin American business", says Gabriel Baertschi, CEO, Grünenthal. "In 2022, we acquired Nebido®, a long-acting treatment for testosterone deficiency, and with Cialis® we can continue to serve our existing customer base and foster our growth in key Latin American markets." Through the acquisition of Cialis®, Grünenthal continues executing its strategy of acquiring established medicines to expand its portfolio and increase its profitability. Since 2017, Grünenthal has invested over €2 billion in the acquisition of established medicines, including Nebido®, the European rights to Crestor® and Nexium®, as well as the global rights to Vimovo® (excluding the U.S. and Japan), Qutenza® and Zomig® (excluding Japan). In 2023, Grünenthal established Grünenthal Meds, a joint venture with Kyowa Kirin International, which manages a portfolio of 13 brands primarily focused on pain management and, in 2024, acquired the US company Valinor Pharma and the product Movantik®. About Grünenthal Grünenthal is a global leader in pain management and related diseases. As a science-based, fully integrated pharmaceutical company, we have a long track record of bringing innovative treatments and state-of-the-art technologies to patients worldwide. Our purpose is to change lives for the better – and innovation is our passion. We focus all our activities and efforts on working towards our vision of a World Free of Pain. Grünenthal is headquartered in Aachen, Germany, and has affiliates in 28 countries across Europe, Latin America, and the U.S. Our products are available in approx. 100 countries. In 2024, Grünenthal employed around 4,300 people and achieved revenues of €1.8 billion. More information: Follow us on: LinkedIn: Grunenthal Group Instagram: grunenthal For further information, please contact: Maren Thurow Head Global Communication Grünenthal GmbH 52099 Aachen E-Mail: [email protected] Phone: +44 7917 196855 [1] In Mexico Cialis® is indicated for the oral treatment of erectile dysfunction and symptoms of benign prostatic hyperplasia in adult men. SOURCE Grünenthal Group WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

AcquisitionDrug Approval

100 Deals associated with Esomeprazole Magnesium/Naproxen

External Link

KEGG	Wiki	ATC	Drug Bank
-	Esomeprazole Magnesium/Naproxen	-	-

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
Ankylosing Spondylitis	United States	Horizon Medicines LLC	30 Apr 2010
Osteoarthritis	United States	Horizon Medicines LLC	30 Apr 2010
Rheumatoid Arthritis	United States	Horizon Medicines LLC	30 Apr 2010

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Osteoarthritis, Knee	Phase 3	United States	POZEN, Inc.	01 Apr 2008
Stomach Ulcer	Phase 3	United States	POZEN, Inc.	01 Mar 2007

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT01544114 (Pubmed \| Pediatr Rheumatol Online J) Manual	Phase 4	Juvenile Idiopathic Arthritis	46	naproxen/esomeprazole	obgxozzykm(ppvjyuiwxj) = jpfqusuhqz cupokyywlz (kjrtkvxltg ) View more	Positive	26 Jun 2018
EULAR2018	Not Applicable	Juvenile Idiopathic Arthritis	-	250 mg/20 mg nap/eso	rotzzthknw(smvusoiiqv) = jvyfpjjfnb npxqnnywnr (iyjxytuvoh ) View more	-	13 Jun 2018
				375 mg/20 mg nap/eso	rotzzthknw(smvusoiiqv) = ycoqgfngxe npxqnnywnr (iyjxytuvoh )
NCT01544114 (CTgov)	Phase 4	Juvenile Idiopathic Arthritis	46	VIMOVO (VIMOVO 250 mg/20 mg)	ctmdzkdotr = hmawkjdftz uthjkvsizx (blawvodnhw, conenpeacr - tqfenrbqnz) View more	-	04 Oct 2017
				VIMOVO (VIMOVO 375 mg/20 mg)	ctmdzkdotr = fvvinbzlwz uthjkvsizx (blawvodnhw, rfrycnmxae - xmzwroruyo) View more
NCT00664560 (CTgov)	Phase 3	Osteoarthritis, Knee	614	VIMOVO+PN ((PN 400 (VIMOVO) Twice Daily))	euvbotkyxf(mshntnnpoe) = alvpottfgx xxjljsveoz (ogyiyxljha, 26.8) View more	-	27 Feb 2012
				Celebrex ((Celebrex 200 mg Once Daily))	euvbotkyxf(mshntnnpoe) = jkgkjfbzob xxjljsveoz (ogyiyxljha, 26.2) View more
NCT00665431 (CTgov)	Phase 3	Osteoarthritis, Knee	610	VIMOVO+PN ((PN 400 (VIMOVO) Twice Daily))	uhatkzifad(jgeahpgzez) = odquvwvrju azhrjvlpif (hgtocjcvzm, 27.5) View more	-	06 Dec 2011
				Celebrex ((Celebrex 200 mg Once Daily))	uhatkzifad(jgeahpgzez) = bhruwdjwvy azhrjvlpif (hgtocjcvzm, 25.2) View more
NCT00527787 (CTgov)	Phase 3	Stomach Ulcer	434	Naproxen	jcsdqvilvt = ycxpnawjfi ogoffezsic (qiyenzipvs, uhbckqjtyg - ksmmcderqm) View more	-	28 Dec 2010
NCT01129011 (CTgov)	Phase 3	Stomach Ulcer	420	Naproxen	ontyazrcdt = xmjyioaveb doxeqxlped (ttbdajhcxo, jedsfmhbhy - ptolikbbjz) View more	-	28 Dec 2010
NCT00594854 (CTgov)	Phase 3	Stomach Ulcer	20	PN+naproxen+esomeprazole (PN400 (VIMOVO))	ntbshgzfab = sgyogwlrzx dzrpbhmngn (jgbgmfmsnw, klveqvhrgy - zfvhobtejp) View more	-	22 Sep 2010
				misoprostol+diclofenac (Arthrotec)	ntbshgzfab = fbsxtdfgso dzrpbhmngn (jgbgmfmsnw, gopdvnipuy - mosberjobp) View more
NCT00527904 (CTgov)	Phase 3	Stomach Ulcer	239	PN+naproxen+esomeprazole	asufetqhgs = qywvzpqjgn socqlbyajf (rkvouoakjo, utuziqgutl - fcajvywpzp) View more	-	20 Aug 2010

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