Efmedaglutide alfa
A once-weekly GLP-1 drug from China's CSPC, built by joining GLP-1 to an antibody Fc stem. Marketing applications for weight management and type 2 diabetes are under review in China; the published human data so far are two phase 1 trials.
Efmedaglutide alfa (code TG103, also TJ103) is a long-acting GLP-1 receptor agonist made of two copies of a GLP-1 chain, each joined to a hybrid antibody Fc fragment, so that one injection under the skin lasts a week. CSPC Pharmaceutical licensed it for mainland China from I-Mab in 2018 and has run phase 3 trials in obesity and type 2 diabetes. In a 12-week phase 1b trial in 48 Chinese adults with overweight or obesity, weekly doses of 15 to 30 mg lowered body weight by 5.1 to 5.7 kg on average, against 1.4 kg on placebo (PMID 38807146). China's drug regulator accepted applications for weight management in October 2025 and for type 2 diabetes in June 2026 (company announcements). It is approved nowhere, and the FDA holds no application for it.
Used in human trials: 15-30 mg, once weekly, subcutaneous (Studied dose) Details ↓
Recommended Dosing
Used in human trials
Typical range15–30 mg · once weekly Human studyPMID 38807146compare across peptides →
No manufacturer dose exists for this use: these are amounts given in published trials, not recommendations.
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Mechanism of action
GLP-1 is a gut hormone released after meals. Acting on its receptor, it makes the pancreas release more insulin when blood sugar is high, holds back glucagon, slows stomach emptying and reduces appetite. The body's own GLP-1 lasts only minutes in the blood. Efmedaglutide alfa replaces the alanine at position 8, the point where the enzyme DPP-4 cuts the hormone, with glycine, and joins the chain through an IgD hinge to an IgG4-based Fc fragment, the stem of an antibody, making a two-chain protein many times the size of the hormone (FDA GSRS UNII P7M6NNA87N). In people the half-life was about 147 to 185 hours after one dose (PMID 37062422) and about 110 to 116 hours at steady state with weekly dosing (PMID 38807146), long enough for once-a-week injections. Dulaglutide is built on the same idea with a different Fc and three changes to the GLP-1 chain; efsubaglutide alfa uses the Fc of a different antibody subclass.
Primary uses
- Investigational: long-term weight management in adults with overweight or obesity (phase 3 completed; marketing application under review in China)
- Investigational: type 2 diabetes, alone or with metformin (phase 3 completed; marketing application under review in China)
Typical dosing
Used in human trials: 15, 22.5 or 30 mg under the skin once a week for 12 weeks, reached by raising the dose weekly over 1 to 4 weeks, in the phase 1b trial in adults with overweight or obesity (PMID 38807146). Single doses of 3 to 22.5 mg were tested in healthy adults (PMID 37062422). The obesity phase 3 trial used 22.5 mg weekly (NCT05997576), and the diabetes phase 3 with metformin used 7.5 mg or 15 mg weekly, the higher dose after four weeks at 7.5 mg (CSPC, September 30, 2026). Trial doses, not recommendations; no dose is approved.
Educational information, not medical advice. The doses on this page come from approved labels, published studies and, where no study exists, amounts reported by users. None is a recommendation for you. An unapproved compound has no established safe or effective human dose, and products sold for “research use only” are not made or tested for people. Talk to a doctor before acting on anything on this site, including before you start, stop or change any medicine or dose. Full medical disclaimer.
Regulatory status
Not approved anywhere. Drugs@FDA and the openFDA label endpoint hold no record for efmedaglutide alfa or TG103 (searched November 4, 2026), and ChEMBL still records a highest phase of 2 (CHEMBL6068240). In China, CSPC Pharmaceutical says the NMPA accepted a marketing application for long-term weight management in adults with overweight or obesity (announced October 13, 2025) and a second for type 2 diabetes (announced June 18, 2026); neither had been approved in any announcement read on November 4, 2026. The registered trials are sponsored by CSPC's subsidiaries: phase 1 single and multiple dose studies, phase 2 trials in obesity and diabetes, and three completed phase 3 trials (NCT05997576 in obesity, NCT06258148 as monotherapy and NCT06235086 with metformin in type 2 diabetes), none with results posted.
Status as of this entry's last review, November 4, 2026. Approvals, compounding rules and sport rules change; the regulatory tracker is checked more often.
What the studies show
Two papers in PubMed study this drug by name, both phase 1 trials in China under its code TG103. The phase 2 and phase 3 trials are listed after them from ClinicalTrials.gov; none has posted results, and the only phase 3 figures so far are CSPC's own conference report. Reviews that only list TG103, and Genexine's paper on a related hybrid-Fc GLP-1, are in References.
Human · 2023
Phase 1a: single doses in healthy Chinese adults
Thirty-two healthy volunteers were enrolled in four groups of eight, each randomised three to one to one injection under the skin of 3, 7.5, 15 or 22.5 mg or placebo. All completed the study. Eighty-four adverse events occurred in 25 people, every one mild or moderate and gone without treatment; on the drug the commonest were loss of appetite (about 42%), then nausea, wind and small laboratory changes. Blood levels peaked at 36 to 48 hours and rose in step with the dose, and the mean half-life ran from about 147 to 185 hours. Fasting glucose fell against placebo at every dose, most at 15 mg. Registered as NCT03990090; CSPC staff are among the authors.
Human · 2024
Phase 1b: 12 weeks of weekly doses in overweight and obesity
Forty-eight Chinese adults without diabetes (mean BMI about 30) at three centres were randomised three to one to weekly injections climbing to 15, 22.5 or 30 mg, or placebo, for 12 weeks, with no diet or exercise programme. Almost everyone had at least one adverse event (35 of 36 on the drug and 10 of 12 on placebo), mostly grade 1 or 2, with none serious and no one stopping because of one. Average weight loss was 5.65, 5.35 and 5.13 kg in the three dose groups against 1.37 kg on placebo, more than 5% of starting weight in each drug group. The half-life at steady state was 110 to 116 hours. Registered as NCT04855292; CSPC staff are among the authors.
Registry · 2024
Phase 3 with metformin against dulaglutide (company-reported results)
Six hundred and thirty-two Chinese adults whose type 2 diabetes was not controlled on metformin (HbA1c 7.0 to 10.5%) were randomised, open label, to 7.5 mg weekly, 15 mg weekly after four weeks at 7.5 mg, or dulaglutide 1.5 mg, for 28 weeks and then to week 52. CSPC reported at EASD 2026 that HbA1c fell 1.38 points at week 28 on 15 mg, that both doses were non-inferior to dulaglutide, and that at week 52 the falls were 1.31 points on 15 mg and 1.25 on dulaglutide, with 52.2% and 46.8% at an HbA1c of 7% or lower. It described stomach and gut effects as the main adverse events, at similar rates across arms, and no severe low blood sugar. These are the company's figures; nothing is posted on the registry or published in a journal yet.
NCT06235086 · ClinicalTrials.gov record
Registry · 2023
Phase 3 in obesity without diabetes, completed
Six hundred and seventy-five adults with a BMI of 28 or more, or above 24 with a weight-related condition, received 22.5 mg weekly or placebo alongside diet and exercise, with weight change at week 40 as the main measure and follow-up to week 52. Completed in March 2025 with no results posted. CSPC's October 2025 announcement of the marketing application rests mainly on this trial and says weight fell significantly against placebo, without giving a number.
NCT05997576 · ClinicalTrials.gov record
Registry · 2024
Phase 3 on its own in type 2 diabetes, completed
A double-blind, placebo-controlled trial of the drug as the only diabetes medicine in 465 Chinese adults with type 2 diabetes, run from April 2024 to January 2026. No results are posted. CSPC's June 2026 announcement says this trial and the metformin trial support the diabetes application and that HbA1c fell by more than one point within eight weeks, giving no trial-by-trial figures.
NCT06258148 · ClinicalTrials.gov record
Registry · 2024
Phase 2 in obesity without diabetes, completed
Three hundred and fourteen adults with overweight or obesity were randomised to 7.5, 15 or 22.5 mg weekly or matching placebo, February to September 2024. No results are posted or published. Three earlier phase 2 records (NCT05299697, NCT05063253 and NCT05348122, the last comparing weekly and every-two-week dosing with dulaglutide in diabetes) show status unknown.
NCT06226090 · ClinicalTrials.gov record
References
- [clinical-trial] Jin J, et al. "Safety, pharmacokinetics, and pharmacodynamics of TG103, a novel long-acting GLP-1/Fc fusion protein after a single ascending dose in Chinese healthy subjects." Eur J Pharm Sci, 2023;185:106448. PMID: 37062422.
- [clinical-trial] Lin D, et al. "Safety, tolerability, pharmacokinetics, and pharmacodynamics of TG103 injection in participants who are overweight or obese: a randomized, double-blind, placebo-controlled, multiple-dose phase 1b study." BMC Med, 2024;22(1):209. PMID: 38807146.
- [pubmed] An IB, et al. "A glycosylated Fc-fused glucagon-like peptide-1 receptor agonist exhibits equivalent glucose lowering to but fewer gastrointestinal side effects than dulaglutide." Diabetes Obes Metab, 2020;22(8):1455-1468. PMID: 32314505.
- [pubmed] Kokkorakis M, et al. "Emerging pharmacotherapies for obesity: A systematic review." Pharmacol Rev, 2025;77(1):100002. PMID: 39952695.
- [pubmed] Bhat S, et al. "Efficacy and safety of incretin co-agonists: Transformative advances in cardiometabolic healthcare." World J Cardiol, 2025;17(8):107991. PMID: 40949933.
- [clinicaltrials] ClinicalTrials.gov NCT05997576: "A Multicenter, Randomized, Double-blind, Placebo-controlled Phase 3 Study of TG103 Injection in the Management of Non-diabetic Overweight or Obesity" CSPC Baike (Shandong) Biopharmaceutical Co., Ltd. 675 adults without diabetes with a BMI of 28 or more, or over 24 with a weight-related condition, TG103 22.5 mg or placebo added to diet and exercise; primary endpoints the share losing at least 5% and the percent weight change at week 40. November 2023 to March 2025, completed; no results posted. Registry record read November 4, 2026.
- [clinicaltrials] ClinicalTrials.gov NCT06258148: "A Multicenter, Randomized, Double-blind, Placebo-controlled Phase 3 Trial of TG103 Injection Monotherapy Subjects With Type 2 Diabetes Mellitus" CSPC Baike (Shandong) Biopharmaceutical Co., Ltd. 465 participants, April 2024 to January 2026 (primary completion), completed; no results posted. Registry record read November 4, 2026.
- [clinicaltrials] ClinicalTrials.gov NCT06235086: "A Multicenter, Randomized, Open-label, Controlled Phase 3 Trial of TG103 Injection in Combination With Metformin in Subjects With Type 2 Diabetes Mellitus" CSPC Baike (Shandong) Biopharmaceutical Co., Ltd. 632 participants, dulaglutide as comparator, April 2024 to February 2026 (primary completion), completed; no results posted. Registry record read November 4, 2026.
- [clinicaltrials] ClinicalTrials.gov NCT06226090: "A Randomized, Double-blind, Placebo-controlled Phase 2 Study of TG103 Injection in the Management of Non-diabetic Overweight or Obesity" CSPC Baike (Shandong) Biopharmaceutical Co., Ltd. 314 participants, arms of 7.5, 15 and 22.5 mg against placebo, February to September 2024, completed; no results posted. Registry record read November 4, 2026. Earlier phase 2 records NCT05299697 (overweight or obesity, 195 planned), NCT05063253 (overweight or obesity with type 2 diabetes, 208 planned) and NCT05348122 (type 2 diabetes, weekly and two-weekly arms against placebo and dulaglutide, 240 planned) show status unknown.
- [manufacturer] CSPC Pharmaceutical Group Limited. Voluntary announcement, September 30, 2026: phase 3 results of TG103 injection added to metformin against dulaglutide 1.5 mg in 632 Chinese adults with type 2 diabetes, presented as a short oral discussion at EASD 2026 (company statements). https://pdf.dfcfw.com/pdf/H2_AN202609301830055557_1.pdf. Read November 4, 2026.
- [manufacturer] CSPC Pharmaceutical Group Limited. Voluntary announcement, October 13, 2025: China's NMPA accepted the marketing application for efmedaglutide alfa injection, a once-weekly recombinant human GLP-1 Fc fusion protein, for long-term weight management in adults with overweight or obesity, based mainly on a placebo-controlled phase 3 trial; no figures given (company statements). https://doc.irasia.com/listco/hk/cspc/announcement/a251013.pdf. Read November 4, 2026.
- [manufacturer] CSPC Pharmaceutical Group Limited. Voluntary announcement, June 18, 2026: the NMPA accepted a second marketing application, for glycaemic control in adults with type 2 diabetes, based on two phase 3 trials (monotherapy and add-on to metformin) (company statements). https://doc.irasia.com/listco/hk/cspc/announcement/a260618b.pdf. Read November 4, 2026.
- [manufacturer] I-Mab. Press release, June 22, 2026, on the NMPA's acceptance of the type 2 diabetes application: 'Efmedaglutide Alfa (also known as TJ103 or TG103)', a long-acting GLP-1 receptor agonist (company statements). https://tjbio.com/en/news/14775. Read November 4, 2026.
- [manufacturer] CSPC Pharmaceutical Group Limited (HKEX 1093). Announcement, December 17, 2018: licence from I-Mab Biopharma (Shanghai) of the long-acting recombinant GLP-1 Fc fusion protein TG103 for all indications in mainland China, built on the hyFc fusion protein platform (company statement). https://doc.irasia.com/listco/hk/cspc/announcement/a181217.pdf. Read November 4, 2026.
- [other] FDA Global Substance Registration System, efmedaglutide alfa, UNII P7M6NNA87N (CAS 2919801-97-9; INN list number 13131), read November 4, 2026: GLP-1(7-37) with glycine at position 8, fused to a hybrid Fc of human IgD (hinge and part of CH2) and IgG4 (CH2 and CH3), a disulfide-linked dimer made in CHO DG44 cells; relationship GLP-1 receptor agonist. https://gsrs.ncats.nih.gov/ginas/app/beta/substances/P7M6NNA87N
- [other] ChEMBL molecule CHEMBL6068240 (EFMEDAGLUTIDE ALFA), read November 4, 2026: molecule type Protein; INN stems ef- and -tide; highest clinical phase recorded 2; a 285-residue chain with its disulfide bridges and an N-glycosylation site. https://www.ebi.ac.uk/chembl/compound_report_card/CHEMBL6068240/
- [other] US FDA, Drugs@FDA and the drug label endpoint (openFDA), searched November 4, 2026: no application and no label record for efmedaglutide alfa or TG103.
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This entry is for educational purposes only and does not constitute medical advice. Dosing information reflects published regulatory or research data and is not a recommendation. Many compounds described here are not approved for human use in the United States. Consult a licensed medical professional before considering any peptide therapy.