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Osteoporosis

Musculoskeletal 5 original drugs

Novel Drugs

Reformulations

Drug Targets

Musculoskeletal indication. Osteoporosis has 5 FDA-approved novel treatments, led by Amgen, with 67 active industry clinical trials across 10 drug targets. Explore market leaders, treatments by mechanism, the clinical pipeline, and drug targets below.

Osteoporosis Market Leaders

Companies with the most FDA-approved novel Osteoporosis drugs.

Amgen

original drugs

ACCORD BIOPHARMA INC.

original drugs

RADIUS

original drugs

Phase 3 Readouts Pro

2 active Phase 3 trials with confidence-graded completion dates.

Full calendar →

Q1 2027

QL1206

Qilu Pharmaceutical Co., Ltd.

Estimated · aging NCT07062978

Q2 2027

QLG2128

Qilu Pharmaceutical Co., Ltd.

Estimated · stale NCT06898060

Anchored on CT.gov primary completion date. Topline announcements typically precede this by 3–9 months. Confidence labels combine date type (ACTUAL/ESTIMATED) with last-update freshness.

Osteoporosis Treatments by Mechanism

Top 5 mechanisms across 28 industry trials with a known mechanism of action.

See full pipeline →

RANK Ligand Inhibitor

10 trials 1 active 3 sponsors

Parathyroid Hormone Analog

9 trials 4 sponsors

Farnesyl pyrophosphate synthase

6 trials 1 sponsor

Parathyroid Hormone-Related Peptide Analog

2 trials 1 sponsor

Tumor Necrosis Factor Blocker

1 trials 1 sponsor

MoA derived from FDA pharmClassEpc when intervention matches an approved drug. Codenamed clinical-stage assets without an approved counterpart show "—" and aren't grouped here — they're still in the phase tables below.

Osteoporosis Clinical Pipeline by Phase

150 industry-sponsored trials across 60 sponsors

View full landscape →

Showing 17 of 17 trials

Sponsor	Asset	MoA	Status	Primary Completion	NCT
Amgen	Prolia	RANK Ligand Inhibitor [EPC]	ACTIVE NOT RECRUITING	2027-01-23	NCT06332014
Amgen	Prolia®	—	ACTIVE NOT RECRUITING	2027-04-27	NCT06588153
Amgen	Romosozumab	—	COMPLETED	2025-10-18	NCT06079476
Dong-A ST Co., Ltd.	Risedronate Sodium 35 MG [Actonel]	—	COMPLETED	2025-07-23	NCT05630768
Amgen	—	—	COMPLETED	2017-12-18	NCT02576652
Eli Lilly	Teriparatide	Parathyroid Hormone Analog [EPC]	COMPLETED	2016-07	NCT01709110
Eli Lilly	Teriparatide	Parathyroid Hormone Analog [EPC]	COMPLETED	2015-08	NCT00887354
Amgen	Denosumab	RANK Ligand Inhibitor [EPC]	COMPLETED	2015-01-07	NCT01732770
Eli Lilly	Teriparatide	Parathyroid Hormone Analog [EPC]	COMPLETED	2014-06	NCT01753856
Hanlim Pharm. Co., Ltd.	Risedronate/Cholecalciferol combination(montly)	—	COMPLETED	2014-05-29	NCT01904110
Hanlim Pharm. Co., Ltd.	Risedronate/Cholecalciferol combination	—	COMPLETED	2013-12	NCT01675297
Organon and Co	alendronate 70-mg/vitamin D3 5600 IU combination tablet (Fosamax Plus)	—	COMPLETED	2013-01-10	NCT01350934
Eli Lilly	Teriparatide	Parathyroid Hormone Analog [EPC]	COMPLETED	2011-12	NCT01430104
Eli Lilly	Teriparatide	Parathyroid Hormone Analog [EPC]	COMPLETED	2010-10	NCT00927186
Novartis	zoledronic acid	Farnesyl pyrophosphate synthase	COMPLETED	2010-07	NCT00745485
Organon and Co	alendronate sodium (+) cholecalciferol	—	COMPLETED	2009-04-10	NCT00729651
Warner Chilcott	risedronate	—	TERMINATED	2009-02	NCT00577395

Showing 65 of 65 trials

Sponsor	Asset	MoA	Status	Primary Completion	NCT
Qilu Pharmaceutical Co., Ltd.	QL1206	—	RECRUITING	2027-01	NCT07062978
Mabwell (Shanghai) Bioscience Co., Ltd.	9MW0311	—	RECRUITING	2026-04-30	NCT06804590
Qilu Pharmaceutical Co., Ltd.	QLG2128	—	NOT YET RECRUITING	2027-05	NCT06898060
Shanghai Biomabs Pharmaceutical Co., Ltd.	CMAB807 Injection	—	COMPLETED	2024-11-01	NCT04591275
Enzene Biosciences Ltd.	ENZ215	—	COMPLETED	2024-07-18	NCT05405725
Biocon Biologics UK Ltd	Bmab 1000	—	COMPLETED	2024-06-12	NCT05345691
Alvotech Swiss AG	AVT03	—	COMPLETED	2024-05-07	NCT05395091
Shenzhen Salubris Pharmaceuticals Co., Ltd.	SAL056 (56.5μg)	—	COMPLETED	2023-12-30	NCT07028320
mAbxience Research S.L.	MB09 (denosumab biosimilar)	—	COMPLETED	2023-12-14	NCT05338086
UCB Biopharma SRL	Romosozumab	—	COMPLETED	2023-11-09	NCT05067335
Gedeon Richter Plc.	RGB-14-P	—	COMPLETED	2023-10-02	NCT05087030
Fresenius Kabi SwissBioSim GmbH	FKS518	—	COMPLETED	2023-08-07	NCT04934072
Celltrion	CT-P41	—	COMPLETED	2023-05-18	NCT04757376
Teva Pharmaceuticals USA	—	—	COMPLETED	2022-12-31	NCT04729621
Samsung Bioepis Co., Ltd.	SB16 (Proposed Denosumab Biosimilar)	—	COMPLETED	2022-06-20	NCT04664959
Novartis	GP2411	—	COMPLETED	2022-04-22	NCT03974100
Amgen	Denosumab	RANK Ligand Inhibitor [EPC]	COMPLETED	2021-12-13	NCT03164928
Radius Health, Inc.	—	—	COMPLETED	2021-10-05	NCT04064411
Mabwell (Shanghai) Bioscience Co., Ltd.	MW031	—	COMPLETED	2021-09-27	NCT05215977
Radius Health, Inc.	Abaloparatide	Parathyroid Hormone-Related Peptide Analog [EPC]	COMPLETED	2021-08-17	NCT03512262
Radius Health, Inc.	Abaloparatide	Parathyroid Hormone-Related Peptide Analog [EPC]	COMPLETED	2020-07-15	NCT03710889
Amgen	romosozumab HCP administration with PFS	—	COMPLETED	2019-04-11	NCT03432533
Novartis	Zoledronic acid	Farnesyl pyrophosphate synthase	COMPLETED	2019-02-27	NCT01197300
Pfenex, Inc	Teriparatide (PF708)	—	COMPLETED	2018-05	NCT03002428
Novartis	Zoledronic acid	Farnesyl pyrophosphate synthase	COMPLETED	2018-03-05	NCT00799266
Amgen	Romosozumab	—	COMPLETED	2018-02-12	NCT02791516
Amgen	Romosozumab	—	COMPLETED	2017-02-27	NCT01631214
Radius Health, Inc.	Alendronate	—	COMPLETED	2016-10-03	NCT01657162
Amgen	Denosumab	RANK Ligand Inhibitor [EPC]	COMPLETED	2016-05-12	NCT00925600
Amgen	Romosozumab	—	COMPLETED	2016-02-15	NCT02186171
Amgen	Romosozumab	—	COMPLETED	2015-12-14	NCT01575834
Takeda	NE-58095 IR	—	COMPLETED	2015-11	NCT02063854
GSK	Denosumab	RANK Ligand Inhibitor [EPC]	COMPLETED	2015-08	NCT02014467
Amgen	Denosumab (CP2)	—	COMPLETED	2015-07	NCT02157948
Amgen	Romozosumab	—	COMPLETED	2015-05-14	NCT01796301
Asahi Kasei Therapeutics Corporation	AK156	—	COMPLETED	2015-01	NCT01522521
Radius Health, Inc.	BA058 80 mcg	—	COMPLETED	2014-10	NCT01343004
Amgen	Romosozumab 90 mg/mL	—	COMPLETED	2014-09-08	NCT02016716
Roche	ibandronate [Bonviva/Boniva]	—	COMPLETED	2014-07	NCT01290094
Merck	Odanacatib	—	COMPLETED	2013-07-22	NCT01120600
Novartis	Zoledronic acid	Farnesyl pyrophosphate synthase	COMPLETED	2013-04	NCT00718861
Chiesi Farmaceutici S.p.A.	disodium clodronate 200 mg/4 ml with 1% lidocaine	—	COMPLETED	2013-03	NCT01348243
GSK	denosumab	RANK Ligand Inhibitor [EPC]	COMPLETED	2013-02	NCT01495000
Organon and Co	MK-217A/Alendronate Sodium 70-mg/Vitamin D3 5600 IU Combination Tablet	—	COMPLETED	2012-12-05	NCT01437111
GSK	denosumab	RANK Ligand Inhibitor [EPC]	COMPLETED	2012-12	NCT01457950
Alvogen Korea	Test group	—	COMPLETED	2012-09	NCT01581320
Daiichi Sankyo Co., Ltd.	Denosumab	RANK Ligand Inhibitor [EPC]	COMPLETED	2012-06	NCT00680953
Amgen	Actonel®	—	COMPLETED	2011-12-21	NCT00919711
Novartis	Zoledronic acid	Farnesyl pyrophosphate synthase	COMPLETED	2011-12	NCT00909961
Amgen	Ibandronate	—	COMPLETED	2011-11	NCT00936897
Amgen	60 mg denosumab	—	COMPLETED	2011-06-21	NCT00980174
Pfizer	bazedoxifene 20 mg/ conjugated estrogens 0.45 mg	—	COMPLETED	2011-02	NCT00808132
Tarsa Therapeutics, Inc.	Oral Calcitonin Tablets	—	COMPLETED	2011-02	NCT00959764
Hanlim Pharm. Co., Ltd.	risedronate combine	—	COMPLETED	2010-08	NCT01806792
Organon and Co	FOSAVANCE 5600 (Alendronate Sodium (+) cholecalciferol)	—	COMPLETED	2010-07	NCT00692913
Amgen	Denosumab	RANK Ligand Inhibitor [EPC]	COMPLETED	2010-06	NCT00890981
Astellas	YM529 / ONO-5920	—	COMPLETED	2010-04	NCT00794443
Merck	Odanacatib	—	COMPLETED	2010-03-23	NCT00729183
Eli Lilly	teriparatide	Parathyroid Hormone Analog [EPC]	COMPLETED	2008-05	NCT00577863
Hamad Medical Corporation	Denosumab 60 MG/ML Prefilled Syringe	—	TERMINATED	2019-04-08	NCT03040765
Merck	odanacatib	—	TERMINATED	2014-11-11	NCT01803607
Evangelisches Krankenhaus Lutherhaus gGmbH	Alendronate	—	TERMINATED	2013-03	NCT01512446
Novartis	Zoledronic Acid	Farnesyl pyrophosphate synthase	TERMINATED	2012-06	NCT01166178
Xentria, Inc.	MAB-22	—	WITHDRAWN	2027-10	NCT06504966
Merck	Odanacatib	—	WITHDRAWN	2015-02	NCT01552122

Showing 25 of 25 trials

Sponsor	Asset	MoA	Status	Primary Completion	NCT
Shenzhen Salubris Pharmaceuticals Co., Ltd.	SAL056 56.5μg	—	RECRUITING	2026-07-30	NCT07579936
Angitia Biopharmaceuticals	AGA2118	—	ACTIVE NOT RECRUITING	2026-12	NCT06577935
Entera Bio Ltd.	EBP05	—	COMPLETED	2021-04-27	NCT04003467
dsm-firmenich Switzerland AG	—	—	COMPLETED	2018-09	NCT02527668
Pfizer	rhBMP-2/CPM injection and bisphosphonates, calcium, and vitamin D (oral bisphosphonate therapy)	—	COMPLETED	2015-04-24	NCT00752557
Amgen	Romosozumab	—	COMPLETED	2014-10-09	NCT01992159
Ultragenyx Pharmaceutical Inc	BPS804 20mg/Kg	—	COMPLETED	2013-10	NCT01406548
Radius Health, Inc.	Abaloparatide Transdermal (50 mcg)	—	COMPLETED	2013-08-02	NCT01674621
Eli Lilly	LY2541546	—	COMPLETED	2012-05	NCT01144377
Unigene Laboratories Inc.	PTH analog	—	COMPLETED	2011-10	NCT01321723
Merck	Odanacatib	—	COMPLETED	2011-09-15	NCT00885170
Eli Lilly	Subcutaneous Teriparatide	—	COMPLETED	2011-09	NCT01011556
PhytoHealth Corporation	PH3	—	COMPLETED	2011-07	NCT00693667
Merck	MK-5442	—	COMPLETED	2011-06	NCT00996801
X-pert Med GmbH	—	—	COMPLETED	2011-04	NCT01415050
Amgen	Alendronate	—	COMPLETED	2011-02-21	NCT00896532
Amgen	Previous denosumab	—	COMPLETED	2010-06	NCT00887965
BioActor	—	—	COMPLETED	2010-03	NCT00789425
Warner Chilcott	150 mg	—	COMPLETED	2009-10	NCT00918749
Eli Lilly	arzoxifene	—	COMPLETED	2009-10	NCT00767299
TransPharma Medical	Teriparatide	Parathyroid Hormone Analog [EPC]	COMPLETED	2009-03	NCT00535860
Tarsa Therapeutics, Inc.	Recombinant Salmon Calcitonin (rsCT)	—	COMPLETED	2008-04	NCT00620854
Elvir SAS	—	—	COMPLETED	—	NCT00663221
Merck	MK-5442	—	TERMINATED	2010-12	NCT00960934
Nastech Pharmaceutical Company, Inc.	Teriparatide	Parathyroid Hormone Analog [EPC]	WITHDRAWN	2009-04	NCT00624481

Showing 43 of 43 trials

Sponsor	Asset	MoA	Status	Primary Completion	NCT
HELP Therapeutics Co., Ltd.	Human Umbilical Cord-derived Mesenchymal stem cell	—	ACTIVE NOT RECRUITING	2026-03-06	NCT06949137
Entera Bio Ltd.	EBP05	—	COMPLETED	2026-02-08	NCT05965167
QuadMedicine	TeriQ Patch	—	COMPLETED	2024-12-30	NCT06644040
Angitia Biopharmaceuticals	AGA2118	—	COMPLETED	2024-01-13	NCT05225857
Jiangsu HengRui Medicine Co., Ltd.	SHR-1222	—	COMPLETED	2022-07-18	NCT04435158
Radius Health, Inc.	—	—	COMPLETED	2021-02-09	NCT04936984
Mabwell (Shanghai) Bioscience Co., Ltd.	MW031	—	COMPLETED	2020-12-07	NCT04798313
Shenzhen Salubris Pharmaceuticals Co., Ltd.	SAL001	—	COMPLETED	2020-10-30	NCT04747392
Shanghai Biomabs Pharmaceutical Co., Ltd.	Prolia®	—	COMPLETED	2020-03-21	NCT03925051
Jiangsu HengRui Medicine Co., Ltd.	SHR-1222	—	COMPLETED	2019-10-14	NCT03870100
Radius Health, Inc.	—	—	COMPLETED	2019-05-14	NCT04366726
Addpharma Inc.	Raloxifene 60mg/Cholecalciferol 800IU	—	COMPLETED	2019-03-27	NCT03824171
Addpharma Inc.	AD-101 45mg	—	COMPLETED	2019-01-02	NCT03764462
Hyundai Pharmaceutical Co., LTD.	Bazedoxifene / Cholecalciferol	—	COMPLETED	2017-12-21	NCT03382314
Hyundai Pharmaceutical Co., LTD.	Bazedoxifene 20 mg	—	COMPLETED	2017-08-14	NCT03234244
Red de Terapia Celular	Fucosylated MSC for Osteoporosis	—	COMPLETED	2016-12	NCT02566655
Pfenex, Inc	Teriparatide	Parathyroid Hormone Analog [EPC]	COMPLETED	2016-07	NCT02656810
Zosano Pharma Corporation	ZP-PTH	—	COMPLETED	2015-11	NCT02478879
Soredab	—	—	COMPLETED	2015-05	NCT01478724
GSK	denosumab 60mg	—	COMPLETED	2015-02-17	NCT02135640
Eli Lilly	Blosozumab	—	COMPLETED	2014-07	NCT02109042
Amgen	Romosozumab	—	COMPLETED	2014-02-19	NCT01833754
Asahi Kasei Therapeutics Corporation	AK159	—	COMPLETED	2014-02	NCT01935479
Amgen	Romosozumab	—	COMPLETED	2012-11-21	NCT01588509
Asahi Kasei Therapeutics Corporation	AK159	—	COMPLETED	2012-09	NCT01551602
Yuyu Pharma, Inc.	Maxmarvil®	—	COMPLETED	2012-07	NCT01526278
Pfizer	RN564	—	COMPLETED	2012-05-24	NCT01293487
Amgen	Denosumab	RANK Ligand Inhibitor [EPC]	COMPLETED	2011-07	NCT01221727
Eli Lilly	LY333334	—	COMPLETED	2011-05	NCT01250145
Novartis	PTH134	—	COMPLETED	2011-04	NCT01224717
Merck	Odanacatib	—	COMPLETED	2010-04-26	NCT01068262
Halozyme Therapeutics	rHuPH20	—	COMPLETED	2009-09-21	NCT00807963
Astellas	ONO-5920 / YM529	—	COMPLETED	2009-09	NCT00965978
Warner Chilcott	risedronate DR (Phase III clinical supply)	—	COMPLETED	2009-05	NCT00846196
Acceleron Pharma, Inc., a wholly-owned subsidiary of Merck & Co., Inc., Rahway, NJ USA	ACE-011 or placebo	—	COMPLETED	2008-11	NCT00709540
Novartis	PTH134	—	COMPLETED	2008-08	NCT00676312
Warner Chilcott	Risedronate	—	COMPLETED	2008-02	NCT00699777
GSK	Ronacaleret	—	COMPLETED	—	NCT00651534
Merck	Odanacatib	—	TERMINATED	2016-07-14	NCT01630616
Amgen	Etanercept	Tumor Necrosis Factor Blocker [EPC]	TERMINATED	2016-01	NCT01294397
Eli Lilly	Blosozumab	—	TERMINATED	2015-03	NCT02337387
Cephalon	CEP-37251	—	TERMINATED	2010-10	NCT01159873
Shenzhen Salubris Pharmaceuticals Co., Ltd.	SAL0123	—	ENROLLING BY INVITATION	2026-02-05	NCT07384104

Precision Medicine Biomarkers

All biomarkers →

Biomarkers used for patient selection in Osteoporosis

ER (Estrogen Receptor) (27)

Novel Osteoporosis Drugs by Company (New molecular entities)

4 companies have an FDA-approved novel drug for Osteoporosis.

Amgen 2 drugs

ACCORD BIOPHARMA INC. 1 drug

RADIUS 1 drug

Pfizer 1 drug

Reformulations (14 drugs) Click to expand

Reformulations are FDA-approved versions of existing molecules in new dosage forms (e.g., oral solution vs tablet, extended-release vs immediate-release). They require a new NDA but use an already-proven active ingredient.

Osteoporosis Drug Targets

Molecular targets of approved and investigational Osteoporosis drugs — 10 targets tracked.

Estrogen Receptor 12 RANKL 9 Osteoclasts 3 PTH receptor 3 Farnesyl pyrophosphate synthase 1 PTH1R 1 Gonadotropin 1 ER-α 1 ER-β 1 Sclerostin 1

Biosimilars (9 BLA approved) Click to expand

Biosimilars are biological products highly similar to FDA-approved reference biologics with no clinically meaningful differences in safety, purity, or potency.

ACCORD BIOPHARMA INC.