You're using a free limited version of DrugPatentWatch: Upgrade for Complete Access

Last Updated: February 16, 2025

Investigational Drug Information for Imeglimin


✉ Email this page to a colleague

« Back to Dashboard


What is the drug development status for Imeglimin?

Imeglimin is an investigational drug.

There have been 7 clinical trials for Imeglimin. The most recent clinical trial was a Phase 2 trial, which was initiated on June 1st 2022.

The most common disease conditions in clinical trials are Diabetes Mellitus, Type 2, Diabetes Mellitus, and Liver Diseases. The leading clinical trial sponsors are Poxel SA, Sumitomo Pharma Co., Ltd., and National Center for Global Health and Medicine, Japan.

There are sixteen US patents protecting this investigational drug and two hundred and sixty-two international patents.

Recent Clinical Trials for Imeglimin
TitleSponsorPhase
Durable Effect of Imeglimin on the Glycemic Control in Patients With Type 2 Diabetes MellitusSumitomo Pharma Co., Ltd.Phase 4
Durable Effect of Imeglimin on the Glycemic Control in Patients With Type 2 Diabetes MellitusNational Center for Global Health and Medicine, JapanPhase 4
Pharmacokinetics of Imeglimin in Hepatic Impaired SubjectsPoxel SAPhase 1

See all Imeglimin clinical trials

Clinical Trial Summary for Imeglimin

Top disease conditions for Imeglimin
Top clinical trial sponsors for Imeglimin

See all Imeglimin clinical trials

US Patents for Imeglimin

Drugname Patent Number Patent Title Patent Assignee Estimated Expiration
Imeglimin ⤷  Try for Free Biguanide compositions and methods of treating metabolic disorders ELCELYX THERAPEUTICS, INC. (San Diego, CA) ⤷  Try for Free
Imeglimin ⤷  Try for Free Controlled release dosage form TRIASTEK, INC. (Nanjing, CN) ⤷  Try for Free
Imeglimin ⤷  Try for Free Biguanide compositions and methods of treating metabolic disorders Anji Pharma (US) LLC (Boxford, MA) ⤷  Try for Free
>Drugname >Patent Number >Patent Title >Patent Assignee >Estimated Expiration

Development Update and Market Projection for Imeglimin

Introduction to Imeglimin

Imeglimin is a novel, first-in-class oral drug candidate developed by Poxel Pharma, targeting the mitochondrial respiratory chain to address type 2 diabetes. This innovative approach sets Imeglimin apart from existing treatments, making it a promising therapeutic option for managing this progressive disease.

Clinical Development and Trials

Phase 3 TIMES Program in Japan

Imeglimin has successfully completed the Phase 3 TIMES (Trials of IMeglimin for Efficacy and Safety) program in Japan, conducted in partnership with Sumitomo Dainippon Pharma. The TIMES program, which includes the TIMES 1, TIMES 2, and TIMES 3 trials, demonstrated Imeglimin's efficacy in reducing HbA1c levels as a monotherapy and in combination with other standard treatments such as insulin, metformin, and DPP-4 inhibitors[4].

Regulatory Approval in Japan

Following the positive results from the Phase 3 trials, Sumitomo Dainippon Pharma submitted a Japanese New Drug Application (J-NDA) to the Pharmaceuticals and Medical Devices Agency (PMDA) in July 2020. This submission was supported by extensive preclinical and clinical data, including the TIMES trials[1][3].

Ongoing and Future Development

Poxel is preparing to advance Imeglimin into a Phase 3 development program in the US, Europe, and other countries not covered by the existing agreement with Sumitomo Dainippon Pharma. Despite Metavant not planning to continue the development of Imeglimin at this time, Poxel remains committed to its vision of developing innovative drugs for metabolic diseases and is exploring various options to move forward with Imeglimin[1].

Market Approval and Commercialization

Approval and Launch in Japan

Imeglimin, marketed as TWYMEEG® in Japan, received regulatory approval and was launched in 2021. The drug has shown significant commercial success, with gross sales in Japan increasing by 62% in the second quarter of 2024 compared to the first quarter, and a forecasted increase of 150% in gross sales for the full year 2024 compared to 2023[5].

Post-Marketing Studies

A post-marketing clinical study, TWINKLE, conducted by Sumitomo Pharma, confirmed the safety and tolerability profile of TWYMEEG® in Japanese type 2 diabetic patients with renal impairment. These results are expected to support discussions with regulatory authorities to revise the package insert and recommend TWYMEEG® for patients with renal impairment[5].

Mechanism of Action and Safety Profile

Unique Dual Mechanism

Imeglimin targets the mitochondrial respiratory chain, a unique mechanism of action that differentiates it from other anti-diabetic therapies. This dual mechanism allows Imeglimin to provide additive efficacy benefits when used in combination with other agents such as metformin, DPP-4 inhibitors, and insulin[3][4].

Safety and Tolerability

Clinical studies, including the Phase 3 TIMES trials and drug-drug interaction studies, have consistently shown that Imeglimin has a favorable safety and tolerability profile. It does not induce clinically relevant changes in the pharmacokinetic profiles of other important diabetes medications, making it a safe option for combination therapy[3][4].

Market Projection

Global Type 2 Diabetes Market

The global type 2 diabetes market is expected to see significant growth from 2019 to 2029, with sales projected to reach $136.2 billion by 2029, driven by a compound annual growth rate (CAGR) of 11.5%. Novel therapies, including GLP-1RAs like semaglutide and oral semaglutide, and SGLT-2 inhibitors like dapagliflozin, are expected to drive this growth[2].

Competitive Landscape

In the context of this growing market, Imeglimin's unique mechanism of action and favorable safety profile position it as a competitive option. While traditional branded therapies like sitagliptin are facing market decline due to patent expiries and generic competition, Imeglimin's potential to complement existing therapies and address multiple stages of type 2 diabetes makes it an attractive addition to the treatment armamentarium[2].

Revenue and Royalties

Poxel anticipates significant revenue from royalties on TWYMEEG® sales in Japan, with forecasted gross sales of JPY 11.3 billion (EUR 69.1 million) for FY 2024. The company is also in discussions to monetize these royalties, which will help sustain its operations and capital expenditure[5].

Key Takeaways

  • Clinical Success: Imeglimin has successfully completed the Phase 3 TIMES program in Japan, demonstrating its efficacy and safety.
  • Regulatory Approval: Approved in Japan and marketed as TWYMEEG®, with plans for further regulatory submissions in other regions.
  • Unique Mechanism: Targets the mitochondrial respiratory chain, offering a novel approach to managing type 2 diabetes.
  • Commercial Growth: Significant commercial success in Japan, with growing sales and potential for expansion into other markets.
  • Market Potential: Positioned to benefit from the growing global type 2 diabetes market, driven by the need for innovative and effective therapies.

FAQs

What is Imeglimin and how does it work?

Imeglimin is a first-in-class oral drug candidate that targets the mitochondrial respiratory chain to address type 2 diabetes. It works by improving mitochondrial function, which is crucial for cellular energy production.

What are the key findings from the Phase 3 TIMES trials?

The Phase 3 TIMES trials demonstrated Imeglimin's efficacy in reducing HbA1c levels as a monotherapy and in combination with other standard treatments. The trials also highlighted its favorable safety and tolerability profile.

Is Imeglimin approved for use in any countries?

Yes, Imeglimin, marketed as TWYMEEG®, is approved and launched in Japan. Regulatory submissions are being prepared for other regions, including the US and Europe.

How does Imeglimin compare to other type 2 diabetes treatments?

Imeglimin's unique mechanism of action and favorable safety profile make it a competitive option. It can be used in combination with other therapies, providing additive efficacy benefits without significant drug-drug interactions.

What are the market projections for Imeglimin?

Imeglimin is expected to benefit from the growing global type 2 diabetes market. With forecasted significant sales in Japan and potential expansion into other markets, Imeglimin is poised to become a key player in the treatment of type 2 diabetes.

What is the current commercial performance of TWYMEEG® in Japan?

TWYMEEG® has shown significant commercial success in Japan, with a 62% increase in gross sales in the second quarter of 2024 compared to the first quarter, and a forecasted 150% increase in gross sales for the full year 2024 compared to 2023.

Sources

  1. Poxel Provides Update on Metavant Partnership with Imeglimin - Poxel Pharma
  2. T2D market growth driven by novel GLP-1RAs and once-weekly ... - Pharmaceutical Technology
  3. Poxel Announces Publication of Imeglimin Clinical Study Results in ... - Poxel Pharma
  4. Poxel and Sumitomo Dainippon Pharma Announce Positive Topline Phase 3 Results from TIMES 2 Trial of Imeglimin for the Treatment of Type 2 Diabetes in Japan and Successful Completion of the Pivotal TIMES Clinical Development Program - Sumitomo Pharma
  5. Poxel Reports Revenue for the Second Quarter and First Half 2024 - Poxel Pharma

More… ↓

⤷  Try for Free

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.