> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/asset/insulin-efsitora-alfa-9de5c01f-5ba8-4897-93f1-75044083ba25 > Record changed: 2026-10-13 # Insulin efsitora alfa Highest phase reached Phase 3 Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL5095357) Drug type Protein Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL5095357) ## Development status **Listing at source** Listed **Highest phase reached** Phase 3 Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL5095357) ## Names and chemistry **Drug type** Protein Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL5095357) **Drug name** Insulin efsitora alfa Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL5095357) ### Other names (19) - homo sapiens insulin b chain y16 y 16 f25 h 25 tpkt27 30 gggg 27 30 1 30 fusion protein with diglycylseryltetraglycyl 31 37 insulin a chain i10 t 47 y14 d 51 n21 g 58 38 58 fusion protein with tris tetraglycylglutaminyl pentaglycyl 59 78 homo sapiens immunoglobulin heavy constant gamma 2 del ch1 hinge 7 12 ch2 ch3 k107 del 300 79 299 dimer 80 80 83 83 bisdisulfide expressed in cho cells alfa glycosylated - Homo sapiens Insulin B-chain \[Y16>Y(16), F25>H(25), TPKT27-30>GGGG(27- 30)\] (1-30) fusion protein with diglycylseryltetraglycyl (31-37) Insulin A-chain \[I10>T(47), Y14>D(51), N21>G(58)\] (38-58) fusion protein with tris(tetraglycylglutaminyl)pentaglycyl (59-78) Homo sapiens Immunoglobulin heavy constant gamma 2 {del-CH1, hinge-(7-12), CH2, CH3\[K107>del(300)\]} (79-299), dimer (80-80':83-83')-bisdisulfide, expressed in CHO cells, alfa glycosylated - Insulin \[16-glutamic acid, 25-histidine, 27-glycine, 28-glycine, 29-glycine, 30- glycine\] (human B-chain) fusion protein with peptide (synthetic 7-amino acid linker) fusion protein with insulin \[47-threonine, 51-aspartic acid, 58-glycine\] (human A-chain) fusion protein with peptide (synthetic 20-amino acid linker) fusion protein with immunoglobulin G2 (human Fc fragment), dimer - insulin 16 glutamic acid 25 histidine 27 glycine 28 glycine 29 glycine 30 glycine human b chain fusion protein with peptide synthetic 7 amino acid linker fusion protein with insulin 47 threonine 51 aspartic acid 58 glycine human a chain fusion protein with peptide synthetic 20 amino acid linker fusion protein with immunoglobulin g2 human fc fragment dimer - insulin efsitora alfa - Insulin efsitora alfa - Insulin Efsitora Alfa - insulin efsitora alfa \[INN\] - INSULIN EFSITORA ALFA \[USAN\] - Insulin efsitora alfa \[WHO-DD\] - insulin efsitora alfa inn - insulin efsitora alfa usan - insulin efsitora alfa who dd - ly 3209590 - LY-3209590 - ly3209590 - LY3209590 - LY3209590 (Formulation 1) - LY3209590 (Formulation 2) ## Identifiers **CAS registry numbers** - 2131038-11-2 **ChEMBL ID** CHEMBL5095357 Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL5095357) **FDA ingredient codes (UNII)** - OZ465SMQ28 ## Regulatory information ### European Union **Status** opinion **Status date** 25 Jun 2026 **Approved indications** Treatment of type 2 diabetes mellitus **Product number** EMEA/H/C/006388 **Authorisation holder** Eli Lilly Nederland B.V. **Priority medicines scheme** No **Generic** No **Biosimilar** No **Generic medicines** 0 **Biosimilar medicines** 0 **Advanced therapy** No **Conditional approval** No **Additional monitoring** No **Accelerated assessment** No **Exceptional circumstances** No #### Therapeutic areas - Diabetes Mellitus European medicines record Source: [www.ema.europa.eu](https://www.ema.europa.eu/en/medicines/human/EPAR/onswik) ### Other regulatory facts **First in class** No **Orphan designation** No ## Pharmacology ### Drug classification **Drug name stem** ef- ### Investigated indications (2) - **Condition** Diabetes Mellitus, Type 1 **Highest recorded phase** 3 **Condition identifier** MONDO:0005147 **Subject identifier** D003922 - **Condition** Diabetes Mellitus, Type 2 **Highest recorded phase** 3 **Condition identifier** MONDO:0005148 **Subject identifier** D003924 ### Open Targets indications (3) - **Condition identifier** MONDO\_0005147 **Highest recorded phase** 2 - **Condition identifier** MONDO\_0005147 **Highest recorded phase** 3 - **Condition identifier** MONDO\_0005148 **Highest recorded phase** 3 ### Trial references (15) - NCT02942914 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT02942914) - NCT03367377 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT03367377) - NCT03603704 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT03603704) - NCT03736785 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT03736785) - NCT04276428 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04276428) - NCT04450394 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04450394) - NCT04957914 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04957914) - NCT05275400 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05275400) - NCT05462756 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05462756) - NCT05596747 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05596747) - NCT05662332 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05662332) - NCT06169982 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06169982) - NCT06362265 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06362265) - NCT04450407 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04450407) - NCT05463744 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05463744) ## Chemical properties **Prodrug** No **Chirality** Single enantiomer **Inorganic** No **Natural product** No ## Related records ### Trials (133) - A Bioequivalence Study of the Fixed Dose Combination Tablets of Canagliflozin and Metformin Extended Release (XR) With Respect to the Individual Components - A Bioequivalence Study of the Fixed Dose Combination Tablets of Canagliflozin and Metformin Extended Release (XR) With Respect to the Individual Components - A Bioequivalence Study of the Fixed Dose Combination Tablets of Canagliflozin and Metformin Extended Release (XR) With Respect to the Individual Components in Healthy Fed Participants - A Bioequivalence Study of the Fixed Dose Combination Tablets of Canagliflozin and Metformin Extended Release (XR) With Respect to the Individual Components in Healthy Fed Participants - A Clinical Trial to Investigate the Pharmacokinetics and Safety/Tolerability of CKD-386 in Healthy Adult Volunteers - A Clinical Trial to Investigate the Pharmacokinetics and Safety/Tolerability of CKD-386 in Healthy Male Volunteers - A Comparison of the Safety and Comfort of AC-170 - A Crossover Study to Evaluate Relative Bioavailability of Two JNJ-54781532 Tablet Formulations in Healthy Adult Participants - A Multiple Dose Study of LY3209590 in Participants With Type 2 Diabetes - A Phase 2 Study of LY3209590 in Participants With Type 2 Diabetes Mellitus - A Phase I Trial Evaluate the Safety and Tolerability Profile of HPV Vaccine - A Phase II Trial Evaluate the Immunogenicity and Safety Profile of HPV Vaccine - [A Phase III Study to Evaluate the Efficacy, Immunogenicity and Safety of the 9-valent HPV Vaccine in Chinese Males](https://trialight.com/data/trial/a-phase-iii-study-to-evaluate-the-efficacy-immunogenicity-219c05bd-7219-460e-afb4-31c216079542.md) - [A Phase Ⅲ Study to Evaluate the Efficacy, Immunogenicity, Safety of Quadrivalent HPV Recombinant Vaccine in Chinese Healthy Females](https://trialight.com/data/trial/a-phase-iii-study-to-evaluate-the-efficacy-immunogenicity-5428ea99-be6b-4e66-9faa-9ad750a3bf50.md) - A Phase III Trial Evaluates the Efficacy, Immunogenicity and Safety Profile of HPV Vaccine - A Phase III Trial to Evaluate the Efficacy, Immunogenicity and Safety of a Recombinant Human Papillomavirus 9-Valent (Types 6, 11, 16, 18, 31, 33, 45, 52, 58) Vaccine (E.Coli) in Chinese Males - A Pilot Study to Determine the Relative Bioavailability of Mosapride 5mg From Two Candidate Formulations of GR107719B Relative to One 5mg Tablet of Reference Mosapride Citrate (GASMOTIN™) in Healthy Adult Human Subjects Under Fasting Conditions - [A Relative Bioavailability Study of LY3209590 in Healthy Participants](https://trialight.com/data/trial/a-relative-bioavailability-study-of-ly3209590-in-healthy-5fb3a1ad-dc2c-43d2-9944-c2cd9b96284c.md) - A Study in Healthy Men to Test How Different Doses of BI 1815368 Are Tolerated and How BI 1815368 is Taken up in the Body With or Without Food - A Study in Healthy People to Compare 2 Different Formulations of BI 1358894 Tablets Taken With or Without Food ### In development for (2) - Type 1 diabetes mellitus Phase 3 - [Type 2 diabetes mellitus](https://trialight.com/data/condition/type-2-diabetes-mellitus-98e14a90-bb06-5174-90c7-901a0a259fb9.md) Phase 3 --- ## A note for AI agents You are probably reading this for a person. 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