Our Pipeline

We are relentless in pursuing breakthroughs that boldly change the lives of the communities we serve.

Our pipeline is built on purpose, and our scientific courage drives us to tackle many marginalized, overlooked or forgotten diseases.

Rare Diseases

MEDICINE / CANDIDATE

PHASE

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TEPEZZA™ (teprotumumab-trbw) Fibrotic Thyroid Eye Disease

  • Open-label trial

PHASE 3b / 4

玩弄放荡人妇系列A single-arm, open-label trial of TEPEZZA in patients with fibrotic Thyroid Eye Disease (TED) (previously referred to as inactive TED). In fibrotic TED, the disease is no longer progressive or inflammatory; however, significant disease manifestations such as proptosis (eye bulging) and diplopia (double vision) remain.

For more information about Thyroid Eye Disease, please visit our disease information玩弄放荡人妇系列 page. For more information on TEPEZZA, go to .

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TEPEZZA™ (teprotumumab-trbw) Thyroid Eye Disease

  • OPTIC-X: Phase 3 extension trial

玩弄放荡人妇系列OPEN-LABEL EXTENSION

: A 48-week, open-label clinical extension trial in which patients who participated in the may receive up to eight additional infusions of TEPEZZA. The trial is designed to better understand whether certain patients may benefit from retreatment or longer treatment (more than six months) with teprotumumab. The primary endpoint is proptosis responder rate (the percentage of participants with ≥2 mm reduction in proptosis in the study eye) without deterioration (≥2 mm increase) of proptosis in the fellow eye.

For more information about Thyroid Eye Disease, please visit our disease information page. For more information on TEPEZZA, go to .

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HZN-825 Diffuse Cutaneous Systemic Sclerosis

  • Phase 2b pivotal trial

PHASE 2

HZN-825 is a LPAR1玩弄放荡人妇系列 antagonist in development for the treatment of diffuse cutaneous systemic sclerosis (dcSSc). Diffuse cutaneous systemic sclerosis is a subtype of systemic sclerosis in which excess collagen production causes skin thickening and hardening, or fibrosis, over large areas of the body, usually the fingers, hands, arms, forearms, anterior trunk, legs and face. Compared with other forms of the disease, people with dcSSc are often at a higher risk of internal organ damage, including interstitial lung disease (ILD), gastrointestinal tract and kidney complications. Horizon expects to conduct a Phase 2b trial starting in the first half of 2021.

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TEPEZZA™ (teprotumumab-trbw) Diffuse Cutaneous Systemic Sclerosis

  • Exploratory trial

PHASE 1

An exploratory trial in diffuse cutaneous systemic sclerosis (dcSSc), evaluating additional indications for TEPEZZA. Diffuse cutaneous systemic sclerosis is a subtype of systemic sclerosis in which excess collagen production causes skin thickening and hardening, or fibrosis, over large areas of the body, usually the fingers, hands, arms, forearms, anterior trunk, legs and face.  Compared with other forms of the disease, people with dcSSc are often at a higher risk of internal organ damage, including interstitial lung disease (ILD), gastrointestinal tract and kidney complications. Available literature suggests that the mechanism of action of teprotumumab, which is to block the IGF-1 receptor, could have an impact on fibrotic processes, such as those that are relevant to dcSSc. Horizon expects to conduct an exploratory trial beginning by the end of 2020 to evaluate objective biomarker and clinical endpoints to inform potential subsequent larger and longer duration clinical trials.

For more information about Thyroid Eye Disease, please visit our disease information玩弄放荡人妇系列 page. For more information on TEPEZZA, go to .

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TEPEZZA™ (teprotumumab-trbw) Subcutaneous Administration

  • Pharmacokinetic trial

PHASE 1

A pharmacokinetic trial to explore subcutaneous dosing of TEPEZZA, which is currently administered by infusion. The objective of the trial is to inform the potential for additional administration options for TEPEZZA, which could provide greater flexibility for patients and physicians.

For more information about Thyroid Eye Disease, please visit our disease information page. For more information on TEPEZZA, go to .

Rheumatic Diseases

玩弄放荡人妇系列MEDICINE / CANDIDATE

PHASE

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KRYSTEXXA® (pegloticase) Immunomodulation

  • MIRROR open-label (complete)
  • MIRROR randomized controlled trial

PHASE 3b / 4

: A small open-label trial for methotrexate co-administered with KRYSTEXXA to evaluate the impact of methotrexate weekly for one month prior to dosing with KRYSTEXXA and then throughout Month 6 of treatment with KRYSTEXXA.

玩弄放荡人妇系列: A randomized, double-blind, placebo-controlled efficacy and safety trial for methotrexate co-administered with KRYSTEXXA to evaluate the impact of methotrexate weekly for one month prior to dosing with KRYSTEXXA and then throughout Month 6 of treatment with KRYSTEXXA.

For more information about gout, please visit our disease information玩弄放荡人妇系列 page. For more information on KRYSTEXXA, go to .

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KRYSTEXXA® (pegloticase) Nephrology

  • PROTECT open-label trial in kidney transplant patients with uncontrolled gout

PHASE 3b / 4

: A multicenter, open-label trial which will evaluate the efficacy and safety of KRYSTEXXA among adults with uncontrolled gout who have received a kidney transplant.

For more information about gout, please visit our disease information page. For more information on KRYSTEXXA, go to .

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KRYSTEXXA® (pegloticase) Shorter-Infusion Duration

  • Open-label trial

PHASE 3b / 4

玩弄放荡人妇系列Evaluating the impact of administering KRYSTEXXA over a significantly shorter infusion duration. The initial proof-of-concept work will begin mid-2020. Currently, KRYSTEXXA is infused over a two-hour or longer timeframe.  A shorter infusion duration could meaningfully improve the experience and convenience for patients, physicians and sites of care.

For more information about gout, please visit our disease information玩弄放荡人妇系列 page. For more information on KRYSTEXXA, go to .

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HZN-003 Next-Gen Uncontrolled Gout

  • Exploration of optimized uricase and optimized PEGylation for uncontrolled gout

PRE-CLINICAL

HZN-003 is a genetically engineered uricase derivative, next generation gout biologic with optimized uricase and optimized PEGylation technology.

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HZN-007 Next-Gen Uncontrolled Gout

  • Exploration of optimized uricase and PASylation for uncontrolled gout

PRE-CLINICAL

Collaboration agreement with XL-protein GmbH to identify clinical-stage product candidates that could be used to construct a next-generation gout biologic. If the collaboration agreement identifies clinical stage candidates, Horizon will have the right to license the candidates.

Recent Clinical Milestones

MEDICINE

STATUS

PROCYSBI® (cysteamine bitartrate)

  • New dosage form: Delayed-Release Oral Granules in Packets

TEPEZZA™ (teprotumumab-trbw)

Discovery Collaborations

玩弄放荡人妇系列MEDICINE / CANDIDATE

PHASE

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Gout Discovery Collaboration

  • Exploration of novel approaches to treating gout

玩弄放荡人妇系列PRE-CLINICAL

玩弄放荡人妇系列Collaboration with HemoShear Therapeutics, LLC, to explore novel approaches to identify and validate biological targets to treat gout using HemoShear’s proprietary disease modeling platform, REVEAL-Tx™. The platform combines physiological and computational models of disease to identify novel treatment approaches. This collaboration may lead to potential clinical targets or new studies of which Horizon will have the rights to commercialize any successful candidates.



Clinical Trials

Clinical trials are an important part of the research and development process. People who participate in clinical trials play a vital role in helping physicians and investigators understand how an investigational medicine may be able to safely and effectively treat a specific disease or condition.

For a comprehensive list of current clinical trials involving Horizon medicines, please visit .

 

This information was last updated on May 29, 2020.

C-HZN-00236

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