Track efpeglenatide in Peptimes™
Efpeglenatide is an exendin-4 analogue joined by a polyethylene glycol (PEG) linker to part of a human antibody (an IgG4 Fc fragment), according to FDA's substance registry. (Source: FDA's substance registry (GSRS).)
Is efpeglenatide FDA-approved?
Not in the US. Drugs@FDA lists no application with efpeglenatide as an active ingredient. South Korea has approved it, but that doesn't apply in the US.
Efpeglenatide
Also: Epe, HM11260C, SAR439977, LAPS-Exendin, langlenatide
- Status label in the Peptimes Library
- Approved outside the US
- Routes in Peptimes
- Subcutaneous
- Updated
- 1 Nov 2026
US regulatory status
How to track it in Peptimes
Add efpeglenatide in My Protocols and set the schedule you already follow: days of the week, times of day and a start date. Peptimes never suggests an amount when you log or schedule a dose. Its Library entry shows the status label “Approved outside the US”. In the US it is not FDA-approved. Korean press reports that South Korea’s Ministry of Food and Drug Safety (MFDS) approved Hanmi Pharmaceutical’s efpeglenatide auto-injector, Epe (에페오토인젝터주), on 7 October 2026. That approval doesn’t apply in the US, and other efpeglenatide products don’t share it.
- Logging: the amount you took and how you feel.
- Injection sites: each dose records the site, and Insights shows where you’ve injected and how recently. It never suggests where to inject next.
- Reminders and history: reminders at your times, Dose History, the Calendar and CSV or JSON export work as described on the peptide tracker app page.
Peptimes is a tracking app, not medical advice. Talk to a licensed clinician about your treatment. Peptimes doesn’t sell efpeglenatide or any other compound.
More sources
- Daily Pharm, report on the MFDS approval (in Korean, 7 Oct 2026), checked 1 Nov 2026: MFDS approval of Hanmi Pharmaceutical’s efpeglenatide auto-injector (press report).
- NIH, ClinicalTrials.gov, studies of efpeglenatide, checked 1 Nov 2026: registered studies, Phase 3, sponsored by Sanofi and Hanmi Pharmaceutical.
- FDA, Drugs@FDA, searched 1 Nov 2026: no application lists efpeglenatide as an active ingredient.
- FDA, Global Substance Registration System, Efpeglenatide, checked 1 Nov 2026: its structure and the names HM11260C, SAR439977 and langlenatide.