Wednesday, July 8, 2026

Drug profile · INN

metformin hydrochloride

metformin hydrochloride (QTRILMET) is a mitochondrial complex i (nadh dehydrogenase) inhibitor. Associated with Takeda. Route of administration: oral. Current US regulatory status: approved.

FDA: approved EMA: withdrawn Alimentary tract and metabolism (A10) A10BD
US status approved
Patents linked 15
Pipeline programs 12
News articles 0
Drug details — metformin hydrochloride
US status
approved
Class
Alimentary tract and metabolism (A10)
Route
ORAL
Patents
15
Programs
12
Data quality
0.89

Quick answer

metformin hydrochloride (QTRILMET) is a mitochondrial complex i (nadh dehydrogenase) inhibitor. Associated with Takeda. Route of administration: oral. Current US regulatory status: approved.

Key facts

INN metformin hydrochloride
Brand QTRILMET
Mechanism Mitochondrial complex I (NADH dehydrogenase) inhibitor
Target Mitochondrial complex I (NADH dehydrogenase)
Therapeutic class Alimentary tract and metabolism (A10)
Route ORAL
Formulation FOR SUSPENSION, EXTENDED RELEASE
ATC code A10BD
Originator Takeda

Mechanism of action

Mitochondrial complex I (NADH dehydrogenase) inhibitor

Primary target: Mitochondrial complex I (NADH dehydrogenase)

Approval history

Authority Status Date
FDA approved
EMA withdrawn

Pipeline programs

  1. CT-L03-301 Phase 3 · Celltrion Healthcare Australia · Type 2 diabetes mellitus (T2DM)
  2. GLUCOPHAGE 500 mg tabletki powlekane, Placebo Phase 3 · Bial Portela & · papillary thyroid carcinoma
  3. metformin hydrochloride Phase 3 · United Therapeutics Europe · Breast Cancer
  4. IDE196-009 Phase 2 · IDEAYA Biosciences · Uveal Melanoma
  5. Metformin Hydrochloride ER Phase 2 · Atrium Therapeutics · Sarcoma Metastatic
  6. Placebo, GLUCOPHAGE 500 mg tabletki powlekane Phase 2 · Bial Portela & · idiopathic infertility
  7. 1019/25 Phase 1 · Tillomed Laboratories · Bioavailability study in healthy volunteers under fed condit
  8. 5 mg/500 mg Glipizide Metformin Hydrochloride Tablets Phase 1 · Teva Pharma · Healthy

Related & competitor drugs

  1. agalsidase alfa Alimentary tract and metabolism (A16)
  2. alogliptin Alimentary tract and metabolism (A10)
  3. alogliptin benzoate Alimentary tract and metabolism (A10)
  4. aprepitant Alimentary tract and metabolism (A04)
  5. budesonide Alimentary tract and metabolism (A07)
  6. canagliflozin Alimentary tract and metabolism (A10)
  1. US 12428406

    Methods and compounds for restoring mutant p53 function

    Expires Mon Sep 25 2045 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  2. US 12419880

    Companion diagnostic tool for mutant p53 reactivating compounds

    Expires Mon Sep 18 2045 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  3. US 11963953

    Deuterated compounds for restoring mutant p53 function

    Expires Mon Apr 18 2044 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  4. US 11926632

    Methods and compounds for restoring mutant p53 function

    Expires Mon Mar 07 2044 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  5. US 11814373

    Methods and compounds for restoring mutant p53 function

    Expires Mon Nov 09 2043 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  6. US 11807644

    Methods and compounds for restoring mutant p53 function

    Expires Mon Nov 02 2043 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  7. US 11731953

    Methods and compounds for restoring mutant p53 function

    Expires Mon Aug 17 2043 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  8. US 11339141

    Methods and compounds for restoring mutant p53 function

    Expires Mon May 19 2042 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  9. US 10668021

    Metformin hydrochloride osmotic pump tablet and preparation method therefor

    Expires Mon May 28 2040 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  10. US 10640485

    Methods and compounds for restoring mutant p53 function

    Expires Mon Apr 30 2040 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  11. US 10138219

    Methods and compounds for restoring mutant p53 function

    Expires Mon Nov 22 2038 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  12. US 9320714

    Tablet

    Expires Mon Apr 21 2036 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  13. US 9101660

    Solid preparation

    Expires Mon Aug 06 2035 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  14. US 8900638

    Solid preparation comprising alogliptin and metformin hydrochloride

    Expires Mon Nov 27 2034 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  15. US 7807689

    Dipeptidyl peptidase inhibitors

    Expires Mon Sep 30 2030 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted

Frequently asked questions

What is metformin hydrochloride?

metformin hydrochloride (QTRILMET) is a mitochondrial complex i (nadh dehydrogenase) inhibitor. Associated with Takeda. Route of administration: oral. Current US regulatory status: approved.

What is the brand name for metformin hydrochloride?

QTRILMET is a marketed brand name for metformin hydrochloride. Check FDA Drugs@FDA for the current US label holder and prescribing information.

What is the US approval status of metformin hydrochloride?

metformin hydrochloride has approved status in the United States according to our Drugs@FDA-derived records. Verify on the official FDA label before clinical or commercial decisions.