The information below is only presented for the purposes of providing a general overview of our clinical trials. Other than where specifically noted, these compounds and their uses are investigational and have not been approved by the U.S. Food and Drug Administration.

 Wholly owned U.S.
 Wholly owned
 Collaboration
 Wholly owned U.S.   Wholly owned   Collaboration

Target

Phase

COMPOUND (PARTNER)
DISEASE
TARGET

PHASE 1

PHASE 2

PHASE 3

or registration trial

APPROVED

COMPOUND (PARTNER)
BRAFTOVI® (encorafenib) capsules +
MEKTOVI® (binimetinib) tablets
Disease: BRAF-mutant unresectable or metastatic melanoma
Target: BRAF + MEK
Approved
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Overview

BRAFTOVI + MEKTOVI was approved in the U.S. in June 2018 and is also approved for use in the E.U.

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COMPOUND (PARTNER)
Encorafenib (Ono, Pierre Fabre)
Disease: Cancer
Target: BRAF
Phase 3 / registration trial
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Overview

Encorafenib is a late-stage small molecule BRAF inhibitor which targets key enzymes in the MAPK signaling pathway (RAS-RAF-MEK-ERK). Research has shown this pathway regulates several key cellular activities including proliferation, differentiation, survival and angiogenesis. Inappropriate activation of proteins in this pathway has been shown to occur in many cancers including melanoma and colorectal cancer (CRC). Encorafenib is being studied in clinical trials in combination with other medications in BRAF-mutant melanoma and colorectal cancer (CRC).

These compounds and their uses are investigational and have not been approved by the U.S. Food and Drug Administration. This information is presented only for purposes of providing a general overview of our clinical trials.

COMPOUND (PARTNER)
Binimetinib (Ono, Pierre Fabre)
Disease: Cancer
Target: MEK
Phase 3 / registration trial
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Overview

Binimetinib is a late-stage small molecule MEK inhibitor that targets key enzymes in the MAPK signaling pathway (RAS-RAF-MEK-ERK). Research has shown this pathway regulates several key cellular activities including proliferation, differentiation, survival and angiogenesis. Inappropriate activation of proteins in this pathway has been shown to occur in many cancers including melanoma and colorectal cancer (CRC). Binimetinib is being studied in clinical trials in combination with other medications in BRAF-mutant melanoma and colorectal cancer (CRC), and in combination with immuno-oncology PD-1/PD-L1 checkpoint inhibitors in several solid tumor populations.

These compounds and their uses are investigational and have not been approved by the U.S. Food and Drug Administration. This information is presented only for purposes of providing a general overview of our clinical trials.

COMPOUND (PARTNER)
Vitrakvi® (larotrectinib; Bayer AG)
Disease: Cancer
Target: Trk family
Approved
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Overview

Vitrakvi® (larotrectinib/LOXO-101) is an oral and selective inhibitor of tropomyosin receptor kinases (Trk), a family of signaling proteins that are thought to play an important role in cellular communication and tumor growth. Growing research suggests that the NTRK genes, which encode for Trk, can become abnormally fused to other genes, resulting in growth signals that can lead to cancer in many sites of the body. Vitrakvi targets Trk, turning off the signaling pathway that allows Trk fusion cancers to grow. In November 2018, the U.S. Food and Drug Administration (FDA) approved Vitrakvi. In July 2013, Array initiated a multiyear license and collaboration agreement with Loxo Oncology for certain Array-invented compounds, including Vitrakvi; LOXO-292, a RET inhibitor; and LOXO-195, a Trk inhibitor.

In February 2019, Eli Lilly acquired Loxo Oncology. Bayer AG has exclusive rights to Vitrakvi. The licensing agreement between Array and Loxo remains in effect.

These compounds and their uses are investigational and have not been approved by the U.S. Food and Drug Administration. This information is presented only for purposes of providing a general overview of our clinical trials.

COMPOUND (PARTNER)
Ganovo®† (danoprevir; Roche)
Disease: Hepatitis C
Target: NS3 Protease
Approved
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Overview

Ganovo® (danoprevir) is a small molecule inhibitor of the hepatitis C virus NS3/4A protease invented by Array and owned by Roche. In June 2018, the China Food and Drug Administration (CFDA) approved Ganovo for the treatment of viral hepatitis C.

These compounds and their uses are investigational and have not been approved by the U.S. Food and Drug Administration. This information is presented only for purposes of providing a general overview of our clinical trials.

COMPOUND (PARTNER)
Selumetinib (AstraZeneca)
Disease: NF1
Target: MEK
Phase 3 / registration trial
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Overview

Selumetinib is an oral small molecule MEK inhibitor invented by Array and licensed to AstraZeneca. AstraZeneca is responsible for development and commercialization of selumetinib.

Selumetinib targets key enzymes in the MAPK signaling pathway (RAS-RAF-MEK-ERK). Inappropriate activation of this pathway has been shown to occur in many conditions, including neurofibromatosis type 1 (NF1).

Selumetinib is being evaluated in a registration trial in patients with NF1.

NF1

Neurofibromatosis (NF) is a genetic disorder that can cause typically non-malignant tumors, or plexiform neurofibromas (PNs), to grow on nerves throughout the body. These tumors can be very disfiguring, painful and disabling. Most tumors are inoperable, while some patients undergo often-repeated surgical procedures. NF1 also causes a number of other health issues, including deafness, blindness, learning disabilities, bone abnormalities and sometimes cancer. PNs exhibit the most rapid growth in young children, and therefore early intervention in children with growing PNs may result in the greatest clinical benefit. NF1, which appears in approximately one in 3,000 people, or 100,000 in the United States, has no cure.

These compounds and their uses are investigational and have not been approved by the U.S. Food and Drug Administration. This information is presented only for purposes of providing a general overview of our clinical trials.

COMPOUND (PARTNER)
Tucatinib (Seattle Genetics)
Disease: Cancer
Target: HER2
Phase 3 / registration trial
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Overview

Tucatinib is an orally active, reversible and selective small molecule HER2 inhibitor invented by Array and licensed to Cascadian Therapeutics (previously named Oncothyreon) for development, manufacturing and commercialization. In March 2018, Seattle Genetics acquired Cascadian Therapeutics. The licensing agreement between Array and Cascadian remains in effect.

Tucatinib is advancing in a registration trial and multiple Phase 1 and 2 trials in patients with breast or colorectal cancers.

These compounds and their uses are investigational and have not been approved by the U.S. Food and Drug Administration. This information is presented only for purposes of providing a general overview of our clinical trials.

COMPOUND (PARTNER)
Ipatasertib (Genentech)
Disease: Cancer, solid tumors
Target: AKT
Phase 3 / registration trial
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Overview

Ipatasertib is an AKT inhibitor invented by Array under a collaboration agreement with Genentech. Array has received certain clinical milestones and is entitled to additional potential clinical and commercial milestones and royalties on product sales under the agreement.

AKT activity is frequently elevated in cancer via multiple mechanisms, including loss of function of the PTEN tumor suppressor gene or mutations/amplifications of the PIK3CA or AKT genes. AKT pathway activation is associated with poor prognosis and may lead to resistance to chemotherapy. Ipatasertib is being evaluated in Phase 3 trials in patients with prostate cancer or breast cancer and Phase 2 trials in patients with breast cancer, gastric cancer and prostate cancer.

These compounds and their uses are investigational and have not been approved by the U.S. Food and Drug Administration. This information is presented only for purposes of providing a general overview of our clinical trials.

COMPOUND (PARTNER)
Varlitinib (ASLAN)
Disease: Cancer
Target: Pan-HER
Phase 3 / registration trial
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Overview

Varlitinib, a novel, oral pan-HER inhibitor, was invented by Array and licensed to ASLAN Pharmaceuticals. Varlitinib has shown clinical activity in both HER2-positive and EGFR-positive tumors. In January 2018, Array granted ASLAN full global rights to develop, manufacture and commercialize varlitinib. The 2018 agreement replaces and supersedes the July 2011 agreement, between Array and ASLAN. Varlitinib is being developed for biliary tract, gastric, colorectal and breast cancer.

These compounds and their uses are investigational and have not been approved by the U.S. Food and Drug Administration. This information is presented only for purposes of providing a general overview of our clinical trials.

COMPOUND (PARTNER)
ARRY-797
Disease: LMNA-related DCM
Target: p38
Phase 3 / registration trial
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Overview

ARRY-797 is an oral, selective p38 mitogen-activated protein kinase inhibitor. ARRY-797 is being studied in a Phase 3 trial in patients with lamin A/C-related dilated cardiomyopathy (LMNA-related DCM), a rare, degenerative cardiovascular disease caused by mutations in the LMNA gene and characterized by poor prognosis.

These compounds and their uses are investigational and have not been approved by the U.S. Food and Drug Administration. This information is presented only for purposes of providing a general overview of our clinical trials.

COMPOUND (PARTNER)
LOXO-292 (Eli Lilly)
Disease: Cancer
Target: Ret
Phase 3 / registration trial
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Overview

LOXO-292 is an oral and selective investigational new drug in clinical development for the treatment of patients with cancers that harbor abnormalities in the rearranged during transfection (RET) kinase. RET fusions and mutations occur across multiple tumor types with varying frequency. Genomic alterations in RET kinase, which include fusions and activating point mutations, lead to overactive RET signaling and uncontrolled cell growth. LOXO-292 is currently being studied in the global LIBRETTO-001 registration trial.

In July 2013, Array initiated a multiyear license and collaboration agreement with Loxo Oncology for certain Array-invented compounds, including larotrectinib/LOXO-101, a Trk inhibitor; LOXO-292; and LOXO-195, a Trk inhibitor. In February 2019, Eli Lilly acquired Loxo Oncology. The licensing agreement between Array and Loxo remains in effect.

These compounds and their uses are investigational and have not been approved by the U.S. Food and Drug Administration. This information is presented only for purposes of providing a general overview of our clinical trials.

COMPOUND (PARTNER)
ARRY-382
Disease: Cancer
Target: CSF1R
Phase 2
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Overview

ARRY-382 is a wholly owned, potent, highly selective, small molecule inhibitor of CSF-1R kinase activity. Array is advancing a Phase 1/2 dose escalation immuno-oncology trial of ARRY-382 in combination with pembrolizumab (Keytruda®), a programmed cell death 1 (PD-1) receptor antibody, in patients with advanced solid tumors.

These compounds and their uses are investigational and have not been approved by the U.S. Food and Drug Administration. This information is presented only for purposes of providing a general overview of our clinical trials.

COMPOUND (PARTNER)
Motolimod (Celgene)
Disease: Cancer
Target: TLR
Phase 2
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Overview

Motolimod is a small molecule agonist of toll-like receptor 8 invented by Array and licensed to VentiRx. In February 2017, Celgene acquired VentiRx and the motolimod program.

Motolimod is being evaluated in a randomized Phase 2 trial in ovarian cancer.

These compounds and their uses are investigational and have not been approved by the U.S. Food and Drug Administration. This information is presented only for purposes of providing a general overview of our clinical trials.

COMPOUND (PARTNER)
LOXO-195 (Bayer AG)
Disease: Cancer
Target: Trk
Phase 1
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Overview

LOXO-195 is an investigational, next-generation, selective tropomyosin receptor kinases (Trk) inhibitor designed to address potential mechanisms of acquired resistance that may emerge in patients receiving larotrectinib (LOXO-101) or multikinase inhibitors with anti-Trk activity. Trk is a family of signaling proteins that are thought to play an important role in cellular communication and tumor growth. LOXO-195 is currently being evaluated in a Phase 1/2 trial.

In July 2013, Array initiated a multiyear license and collaboration agreement with Loxo Oncology for certain Array-invented compounds, including larotrectinib/LOXO-101, a Trk inhibitor; LOXO-292, a RET inhibitor; and LOXO-195. In February 2019, Eli Lilly acquired Loxo Oncology. Bayer AG has exclusive rights to LOXO-195. The licensing agreement between Array and Loxo remains in effect.

These compounds and their uses are investigational and have not been approved by the U.S. Food and Drug Administration. This information is presented only for purposes of providing a general overview of our clinical trials.

COMPOUND (PARTNER)
AK-1830 (Asahi Kasei Pharma)
Disease: Inflammation and pain
Target: Trk
Phase 1
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Overview

In March 2016, Array announced a strategic collaboration with Asahi Kasei Pharma Corporation (AKP) to develop and commercialize select preclinical tropomyosin receptor kinase A (TrkA) inhibitors, including Array-invented AK-1830 (ARRY-954), for pain, inflammation and other non-cancer diseases. AK-1830 is currently advancing in a Phase 1 trial in Japan. Array retains full commercialization rights for all compounds in all indications in territories outside of Asia. Within Asia, Array retains full rights to cancer indications for all compounds excluding those being developed by AKP.

These compounds and their uses are investigational and have not been approved by the U.S. Food and Drug Administration. This information is presented only for purposes of providing a general overview of our clinical trials.

COMPOUND (PARTNER)
MRTX849 (Mirati Therapeutics)
Disease: Cancer
Target: KRAS G12C
Phase 1
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Overview

MRTX849 is a small molecule inhibitor of KRAS G12C invented by Array in collaboration with Mirati Therapeutics. Mirati owns worldwide development rights to MRTX849 and is evaluating MRTX849 in a Phase 1/2 clinical trial in patients with advanced solid tumors that harbor KRAS G12C mutations.

These compounds and their uses are investigational and have not been approved by the U.S. Food and Drug Administration. This information is presented only for purposes of providing a general overview of our clinical trials.

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Approved in China.

Phase 2 registration trials.

Vitrakvi® is a registered trademark of Bayer AG.