PTH

Modality

PTH, Parathyroid Hormone

Human parathyroid hormone (hPTH), is a polypeptide consisting of 84 amino acids. The biology functions of hPTH include modulation of phosphate and calcium metabolism in blood and bones. Both the full-length hPTH(1-84) hormone and the N-terminal hPTH(1-34) fragment have anabolic effect and increase bone mass.

As the first anabolic agent approved for the treatment of osteoporosis, the N-terminal (1-34) fragment of full-length hPTH hormone is produced in Escherichia coli (E. coli) using recombinant DNA technology. Full-length hPTH (trade name Natpara) produced by E. coli is used as a calcium and vitamin D supplement for the treatment of hypocalcemia in patients with hypoparathyroidism.

PTH for Therapeutic Use

Full length hPTH, hPTH(1–84)

Natpara, a recombinant full length human PTH (1-84) is licensed for the therapy of hypoparathyroidism. Natpara was approved by the FDA in 2015 as a calcium and vitamin D supplement to treat patients with hypoparathyroidism that is poorly controlled by conventional therapy. Conditional Marketing Authorization for rhPTH(1–84) was granted in 2017 by the European Commission.

N-terminal fragment, hPTH(1–34)

Recombinant human parathyroid hormone 1-34 injection (FORTEO) is identical to biologically active region of native hPTH34. PTH 1-34 was first developed by Lilly and produced by recombinant DNA technology using a modified strain of E. coli.

Several approved PTH-containing formulations, including lyophilized powder and injection formulation, are available for daily subcutaneous injection, which reduces the patient's treatment compliance. A long-acting formulation called PTH 1-34 acetate (teridone) has been approved by the Japan PMDA. In addition, transdermal routes are being developed, such as ZP-PTH microneedles.

Yaohai Bio-Pharma Offers One-Stop CDMO Solution for PTH

PTH Pipelines

Generic name	Brand Name/ Altermative Name	Expression System	Indications	Manufacturer	Latest stage
PTH 1-34	hPTH-1-34, LY 333334, MN-10, Forteo, Forsteo、复泰奥, フォルテオ	Escherichia coli (E. coli)	Osteoporosis, Male osteoporosis, Postmenopausal osteoporosis, Glucocorticoid-induced osteoporosis	Eli Lilly	Approval
PTH 1-34	Ostiogen, 珍固	E. coli	Postmenopausal osteoporosis	Shanghai United Cell Biotechnology	Approval
PTH 1-34 biosimilar	SAL001, 欣复泰	E. coli	Postmenopausal osteoporosis	Salubris	Approval
PTH 1-34 biosimilar	Pending Update	Pending Update	Postmenopausal osteoporosis	Teva Pharms	Approval
PTH 1-34 biosimilar	Pfenex, PF-708, Bonsity, Qutavina	Pseudomonas fluorescens	Postmenopausal osteoporosis	Pfenex, Alvogen, Eurogenerics	Approval
PTH 1-34	Kauliv	E. coli	Postmenopausal osteoporosis, Male osteoporosis, Glucocorticoid-induced osteoporosis	Strides Pharma Science Limited	Approval
PTH 1-34	Pending Update	Pending Update	Osteoporosis	Enzene Biosciences	Approval
PTH 1-34	Sondelbay	E. coli	Postmenopausal osteoporosis, Male osteoporosis, Glucocorticoid-induced osteoporosis	Accord Healthcare	Approval
PTH 1-34 biosimilar	Movymia, rhPTH (1-34)	E. coli	Osteoporosis	STADA Arzneimittel AG	Approval
PTH 1-34 -RGB10	Terrosa,テリパラチド, RGB-10	E. coli	Postmenopausal osteoporosis, Male osteoporosis, Osteoporosis	Gedeon Richter, Mochida Pharmaceutical	Approval
PTH 1-34 biosimilar	Bonista, Osteotide, rhPTH (1-34)	NA, Synthetic peptide	Osteoporosis, Postmenopausal osteoporosis	Sun Pharmaceutical Industries Ltd.	Approval
PTH 1-34 biosimilar	Livogiva	Pseudomonas fluorescens	Osteoporosis, Postmenopausal osteoporosis	Theramex Ireland Limited	Approval
PTH 1-34 biosimilar	rhPTH (1-34)	Pending Update	Osteoporosis, Postmenopausal osteoporosis	Zydus Lifesciences Ltd.	Approval
PTH 1-34 biosimilar	Osteofortil, rhPTH (1-34)	Pending Update	Osteoporosis, Postmenopausal osteoporosis	Biosidus SA	Approval
PTH 1-34 biosimilar	Terifrac, INTG8	Pending Update	Osteoporosis, Postmenopausal osteoporosis	Intas Biopharmaceuticals Ltd	Approval
PTH 1-34 biosimilar	Pending Update	Pending Update	Osteoporosis, Postmenopausal osteoporosis	USV Pvt Ltd., Union Square Ventures LLC	Approval
PTH 1-34 biosimilar	rhPTH (1-34)	Pending Update	Osteoporosis, Postmenopausal osteoporosis	AMEGA Biotech	Approval
PTH 1-34 Acetate	once-weekly MN-10-T, Teribone, テリボン	NA, Chemical synthesis	Osteoporosis	Asahi Kasei Pharma	Approval
Abaloparatide	TYMLOS	NA, Chemical synthesis	Osteoporosis	Ipsen, Radius Health, TEIJIN group	Approval
PTH 1-34	HB1082	Pending Update	Osteoporosis	Wuxi Hebang Biotechnology	Submit for approval
PTH 1-34 biosimilar	Pending Update	Pending Update	Osteoporosis	Beijing Genetech Pharmaceutical	Submit for approval
PTH 1-34 , once-weekly	SAL056	Pending Update	Osteoporosis	Salubris	Phase III
PTH 1-34 biosimilar	rhPTH (1-34)	Pending Update	Osteoporosis Postmenopausal osteoporosis	Shanghai United Cell Biotechnology	Phase III
PTH 1-34 biosimilar	Pending Update	Pending Update	Osteoporosis Postmenopausal osteoporosis	Global chemicals, Great Bay Bio	Phase III
PTH 1-34 biosimilar	rhPTH (1-34)	Pending Update	DiGeorge’s syndrome Hypothyroidism	National Institute of Dental and Craniofacial Research	Phase III
PTH 1-34 biosimilar	Pending Update	Pending Update	Postmenopausal osteoporosis	Zhongke Shenglongda Biotechnology	Phase III
PTH 1-34	EB613	Pending Update	Osteoporosis	Entera Bio	Phase II
PTH 1-34	EB612	Pending Update	Hypoparathyroidism	Entera Bio	Phase II
PTH 1-34 transdermal	hPTH(1-34), MicroCor PTH, PTH 1-34 transdermal	Pending Update	Osteoporosis	Corium International, Inc.	Phase II
PTH 1-34 microneedle-ZP-PTH	Micro needle transdermal delivery	Pending Update	Osteoporosis	Zosano Pharma, Asahi Kasei	Phase II
PTH 1-34 biosimilar	AK159	Pending Update	Osteoporosis	Asahi Kasei Pharma Corp.	Phase I
PTH 1-34 biosimilar	SBL-001	Pending Update	Osteoporosis	Stelis Biopharma Pvt Ltd.	Phase I
PTH 1-34 biosimilar	Pending Update	Pending Update	Osteoporosis	Critical Pharmaceuticals Ltd.	Phase I
PTH 1-34 biosimilar	T0003	Pending Update	Osteoporosis	Shanghai Fudan-Zhangjiang Bio-Pharmaceutical, Shanghai Pharmaceuticals	Phase I
PTH 1-34 -Bonosome	Pending Update	Pending Update	Osteoporosis	Minapharm Pharmaceuticals	Phase I
PTH 1-34 -PB (Osteo)-1010	Pending Update	Pending Update	Osteoporosis	Paras Biopharmaceuticals Finland	Pre-clinical
Parathyroid hormone (PTH) fusion polypeptide	long acting PTH 1-34, AEZS-150, DC-PTH	Pending Update	Hypoparathyroidism	Aeterna Zentaris	Pre-clinical
KUR 111	I-0401, KUR 111	Pending Update	Fracture	Kuros Biosciences Ltd.	Phase II
Fibrin-PTH	I-040202, KUR 113	Pending Update	Intervertebral disc degeneration Fracture	Kuros Biosciences Ltd.	Phase II
parathyroid hormone 1-34	Pending Update	Pending Update	Osteoporosis	Celgen biopharma	Phase II
Parathyroid Hormone 1-34	Oral capsules, RT102, RT110	Pending Update	Osteoporosis	Rani Therapeutics LLC	Phase I
PTH-CBD	BMD 1221	Pending Update	Fracture/ Hair growth	BiologicsMD, University of Arkansas System	Pre-clinical
PTH-1A	Parathyroid Hormone Inverse Agonist	Pending Update	Metaphyseal chondrodysplasia, Jansen type	National Institutes of Health	Pre-clinical
Parathyroid Hormone-PLX-PTH	PTH (1-34), hydrogel amino-microspheres	Pending Update	Hypoparathyroidism	ProLynx	Pre-clinical
Abaloparatide-BA-O58	BA-O58	NA, Synthetic peptide	Postmenopausal osteoporosis	Enzene Biosciences	Pre-clinical
Parathyroid Hormone	rhPTH(1-84), NPSP-558, SHP-635, SHP-634, NPSP-795, ALX-111, SB-423562, Natpara, Preotact, Natpar	E. coli	Hypocalcemia, Hypoparathyroidism	Takeda, Shire Plc	Approval
Parathyroid hormone 1-84	rhPTH (1-84)	Pending Update	Osteoporosis Postmenopausal osteoporosis	Kerun biopharm	Phase III
Parathyroid hormone 1-84	Pending Update	Pending Update	Hypocalcemia	Buchang pharma	Phase I
ACP-014	PTH prodrug, TransCon PTH, Yorvipath	Pending Update	Hypoparathyroidism	Ascendis Pharma A/S, VISEN Pharmaceuticals	Approval
Parathyroid hormone related protein (1-36)	1-36 human PTHRP, 1-36 human humoral hypercalcemic factor, HUMAN PTHRP-(1-36)	Pending Update	Osteoporosis	National Institutes of Health	Phase II
NOV004	Pending Update	Pending Update	Osteogenesis imperfecta	Novosteo, Quince Therapeutics	Pre-clinical

Reference:

[1] Kraenzlin ME, Meier C. Parathyroid hormone analogues in the treatment of osteoporosis. Nat Rev Endocrinol. 2011 Jul 12;7(11):647-56. doi: 10.1038/nrendo.2011.108.

[2] Mannstadt M, Bilezikian JP, Thakker RV, Hannan FM, Clarke BL, Rejnmark L, Mitchell DM, Vokes TJ, Winer KK, Shoback DM. Hypoparathyroidism. Nat Rev Dis Primers. 2017 Aug 31;3:17055. doi: 10.1038/nrdp.2017.55.

All Categories

Modality

PTH, Parathyroid Hormone

PTH for Therapeutic Use

Full length hPTH, hPTH(1–84)

N-terminal fragment, hPTH(1–34)

Yaohai Bio-Pharma Offers One-Stop CDMO Solution for PTH

PTH Pipelines

Reference:

MICROBIAL CDMO

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