IP Library Granted Patent US 11,447,535
Granted Patent B2
US 11,447,535 · App. 16/376,190 · Granted Sep 20, 2022

GLP-1 analogues

Inventors: Rajamannar Thennati (Gujarat, IN); Nishith Chaturvedi (Gujarat, IN); Vinod Sampatrao Burade (Gujarat, IN); Pradeep Dinesh Shahi (Gujarat, IN); Muthukumaran Natarajan (Gujarat, IN); Ravishankara Madavati Nagaraja (Gujarat, IN); Rishit Mansukhlal Zalawadia (Gujarat, IN); Vipulkumar Shankarbhai Patel (Gujarat, IN); Kunal Pandya (Gujarat, IN); Brijeshkumar Patel (Gujarat, IN); Dhiren Rameshchandra Joshi (Gujarat, IN); Krunal Harishbhai Soni (Gujarat, IN); Abhishek Tiwari (Gujarat, IN)
Assignee: Sun Pharmaceutical Industries Limited
C07K14/605A61K9/0053A61P3/04A61P3/10A61K38/00
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Quick Facts
Patent No.
US 11,447,535
App. No.
16/376,190
Granted
Sep 20, 2022
Kind
B2
Abstract

The present disclosure pertains to novel Glucagon like Peptide-1 (GLP-1) (7-37) analogs having an amino acid sequence with Leu or Ile at the C-terminal. The new analogs are potent GLP-1 agonists with reduced adverse effect and improved duration of action. The present disclosure further relates to acylated derivatives of the new analogs which have further improved potency and duration of action and are suitable for oral administration. The analogs of present disclosure may be useful in treatment of diabetes and obesity.

Claims (91)

1. A polypeptide having the amino acid sequence:

(SEQ ID NO: 4)

H-X2-X3-X4-G-T-F-T-S-D-V-S-S-Y-L-X16-G-Q-A-A-X21-

E-F-X24-A-W-L-V-R-G-R-G-X33-X34

wherein X2 is Ser, Ser(OMe), D-Ser, D-Ser(OMe), Ala or Aib;

X3 is absent or Gln;

X4 is Glu;

X16 is Glu;

X24 is Ile;

X33 is Leu, -D-Leu, D-Ile or Ile;

X34 is absent; and

X21 is Lys wherein the side chain amino group of Lys is acylated with a moiety:

{-Q-T-U-W-Y-Z

wherein Q and T are absent,

U is absent or —C(O)—CH 2 —O—(CH 2 ) 2 —O—(CH 2 ) 2 —NH—} wherein} is point of attachment with group W;

W is absent or selected from a group consisting of —C(O)—CH 2 —O—(CH 2 ) 2 —O—(CH 2 ) 2 —NH—], —C(O)—NH—(CH 2 ) 3-4 —NH—], —C(O)—C(CH 3 ) 2 —NH—]; and

wherein] is point of attachment with group Y;

Y is —C(O)—(CH 2 ) 2 —CH(COOH)NH— and — is point of attachment with the group Z;

Z is —C(O)—(CH 2 ) n —COOH or —C(O)—(CH 2 ) n —CH 3 wherein n is an integer from 14 to 20.

2. The polypeptide as in claim 1 , wherein X2 is Aib;

X3 is absent;

X33 is Leu;

U is —C(O)—CH 2 —O—(CH 2 ) 2 —O—(CH 2 ) 2 —NH—};

W is —C(O)—CH 2 —O—(CH 2 ) 2 —O—(CH 2 ) 2 —NH—] and

Z is —C(O)—(CH 2 ) n —COOH wherein n is integer 16.

3. The polypeptide as in claim 1 , wherein X2 is Aib;

X3 is absent;

X33 is Leu;

U is —C(O)—CH 2 —O—(CH 2 ) 2 —O—(CH 2 ) 2 —NH—};

W is —C(O)—C(CH 3 ) 2 —NH—]; and

Z is —C(O)—(CH 2 ) n —COOH wherein n is integer 16.

4. The polypeptide as in claim 1 , wherein X2 is Aib;

X3 is absent;

X33 is Leu;

U is —C(O)—CH 2 —O—(CH 2 ) 2 —O—(CH 2 ) 2 —NH—};

W is —C(O)—NH—(CH 2 ) 4 —NH—]; and

Z is —C(O)—(CH 2 ) n —COOH wherein n is integer 16.

5. The polypeptide as in claim 1 , wherein X2 is Aib;

X3 is absent;

X33 is Leu;

U is —C(O)—CH 2 —O—(CH 2 ) 2 —O—(CH 2 ) 2 —NH—};

W is

and

Z is —C(O)—(CH 2 ) n —COOH wherein n is integer 16.

6. The polypeptide as in claim 1 , wherein X2 is Aib;

X3 is absent;

X33 is Leu;

U is —C(O)—CH 2 —O—(CH 2 ) 2 —O—(CH 2 ) 2 —NH—};

W is —C(O)—NH—(CH 2 ) 3 —NH—]; and

Z is —C(O)—(CH 2 ) n —COOH wherein n is integer 16.

7. The polypeptide as in claim 1 , wherein X2 is Ser, Ser(OMe), D-Ser, D-Ser(OMe);

X3 is absent;

X33 is Leu;

U is —C(O)—CH 2 —O—(CH 2 ) 2 —O—(CH 2 ) 2 —NH—};

W is —C(O)—CH 2 —O—(CH 2 ) 2 —O—(CH 2 ) 2 —NH—], —C(O)—NH—(CH 2 ) 3-4 —NH—], —C(O)—C(CH 3 ) 2 —NH—]; and

Z is —C(O)—(CH 2 ) n —COOH or —C(O)—(CH 2 ) n —CH 3 wherein n is an integer from 14 to 20.

8. The polypeptide as in claim 1 , wherein W is selected from a group consisting of —C(O)—NH—(CH 2 ) 3-4 —NH—], —C(O)—C(CH 3 ) 2 —NH—] and

9. The polypeptide as in claim 1 , wherein X2 is Ala;

X3 is absent;

X33 is Leu;

U and W are absent; and

Z is —C(O)—(CH 2 ) n —CH 3 wherein n is integer 14.

10. The polypeptide as in claim 1 , wherein X2 is Aib;

X3 is absent;

X33 is Leu;

U and W are absent; and

Z is —C(O)—(CH 2 ) n —CH 3 wherein n is integer 14.

11. The polypeptide as in claim 1 , wherein X2 is Aib;

X3 is Gln;

X33 is Leu or D-Leu;

U is —C(O)—CH 2 —O—(CH 2 ) 2 —O—(CH 2 ) 2 —NH—};

W is —C(O)—CH 2 —O—(CH 2 ) 2 —O—(CH 2 ) 2 —NH—]; and

Z is —C(O)—(CH 2 ) n —COOH wherein n is integer 16.

12. The polypeptide as in claim 1 , wherein X2 is Aib;

X3 is absent;

X33 is D-Leu;

U is —C(O)—CH 2 —O—(CH 2 ) 2 —O—(CH 2 ) 2 —NH—};

W is —C(O)—CH 2 —O—(CH 2 ) 2 —O—(CH 2 ) 2 —NH—]; and

Z is —C(O)—(CH 2 ) n —COOH wherein n is integer 16.

13. The polypeptide as in claim 1 , wherein X2 is Aib;

X3 is absent;

X33 is Ile;

U is —C(O)—CH 2 —O—(CH 2 ) 2 —O—(CH 2 ) 2 —NH—};

W is —C(O)—CH 2 —O—(CH 2 ) 2 —O—(CH 2 ) 2 —NH—] or —C(O)—NH—(CH 2 ) 4 —NH—]; and

Z is —C(O)—(CH 2 ) n —COOH wherein n is integer 16.

14. The polypeptide as in claim 1 , wherein X2 is Ala;

X3 is absent;

X33 is Leu;

U is —C(O)—CH 2 —O—(CH 2 ) 2 —O—(CH 2 ) 2 —NH—};

W is —C(O)—CH 2 —O—(CH 2 ) 2 —O—(CH 2 ) 2 —NH—]; and

Z is —C(O)—(CH 2 ) n —COOH wherein n is integer 16.

Assignments (2)
RELEASE OF SECURITY INTEREST Recorded Oct 17, 2024
From: WILMINGTON TRUST, NATIONAL ASSOCIATION
To: HAMMER PACKAGING CORP.; MCC-NORWOOD LLC; W/S PACKAGING GROUP, INC; MULTI-COLOR CORPORATION
Reel/Frame 069180/0836 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Nov 7, 2019
From: THENNATI, RAJAMANNAR; CHATURVEDI, NISHITH; BURADE, VINOD SAMPATRAO; SHAHI, PRADEEP DINESH; NATARAJAN, MUTHUKUMARAN; NAGARAJA, RAVISHANKARA MADAVATI; ZALAWADIA, RISHIT MANSUKHLAL; PATEL, VIPULKUMAR SHANKARBHAI; PANDYA, KUNAL; PATEL, BRIJESHKUMAR; JOSHI, DHIREN RAMESHCHANDRA; SONI, KRUNAL HARISHBHAI; TIWARI, ABHISHEK
To: SUN PHARMACEUTICAL INDUSTRIES LIMITED
Reel/Frame 050953/0628 →