A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, 24-Week, Phase 2 Study of Two Doses of EVP-6124 Hydrochloride or Placebo in Subjects With Mild to Moderate Alzheimer's Disease Currently Receiving Memantine Medication With or Without Additional Acetylcholinesterase Inhibitor Co-Medication

The purpose of this study is to evaluate the safety of 2 fixed doses of EVP-6124 hydrochloride (HCl) compared to placebo for 24 weeks in subjects with mild to moderate Alzheimer's disease who are concurrently receiving stable treatment with memantine and currently receiving stable treatment or previously treated with an acetylcholinesterase inhibitor.

Start Date01 Jul 2015

Sponsor / Collaborator

FORUM Pharmaceuticals, Inc.

[+1]

NCT02327182 / TerminatedPhase 3

A Long-Term Safety Study of MT-4666 in Patients With Mild to Moderate Alzheimer's Disease (AD)

The objective of this study is to evaluate the safety and efficacy of 2 fixed dose of MT-4666 administered once daily for 52 weeks with or without receiving a concomitant acetylcholinesterase inhibitors (AChEIs), in patients with mild to moderate Alzheimer's Disease (AD).

Start Date01 Dec 2014

Sponsor / Collaborator

Mitsubishi Tanabe Pharma Corp.

NCT02004392 / TerminatedPhase 3

A 26-Week Extension Study of the Safety and Clinical Effects of EVP-6124 in Subjects With Alzheimer's Disease Currently or Previously Receiving an Acetylcholinesterase Inhibitor Medication

This is a 26-week, randomized extension of the Phase 3 double-blind placebo-controlled studies, EVP-6124-024 and EVP-6124-025. In this extension study, subjects who complete study EVP-6124-024 or EVP-6124-025 and fulfill all entry criteria will be randomized to receive EVP-6124 for an additional 26 weeks.

Start Date01 Jun 2014

Sponsor / Collaborator

FORUM Pharmaceuticals, Inc.

100 Clinical Results associated with Encenicline Hydrochloride

100 Translational Medicine associated with Encenicline Hydrochloride

100 Patents (Medical) associated with Encenicline Hydrochloride

353

Literatures (Medical) associated with Encenicline Hydrochloride

01 Sep 2024·Pharmacopsychiatry

Advancements in Non-Dopaminergic Treatments for Schizophrenia: A Systematic Review of Pipeline Developments

Review

Author: Takehara, Moe ; Hart, Xenia ; Uchida, Hiroyuki ; Komatsu, Yuki ; Hori, Satoko ; Takahashi, Yuna ; Ueno, Fumihiko

Abstract Introduction Conventional antipsychotic drugs that attenuate dopaminergic neural transmission are ineffective in approximately one-third of patients with schizophrenia. This necessitates the development of non-dopaminergic agents. Methods A systematic search was conducted for completed phase II and III trials of compounds for schizophrenia treatment using the US Clinical Trials Registry and the EU Clinical Trials Register. Compounds demonstrating significant superiority over placebo in the primary outcome measure in the latest phase II and III trials were identified. Collateral information on the included compounds was gathered through manual searches in PubMed and press releases. Results Sixteen compounds were identified; four compounds (ulotaront, xanomeline/trospium chloride, vabicaserin, and roluperidone) were investigated as monotherapy and the remaining 12 (pimavanserin, bitopertin, BI 425809, encenicline, tropisetron, pregnenolone, D-serine, estradiol, tolcapone, valacyclovir, cannabidiol, and rimonabant) were examined as add-on therapy. Compared to the placebo, ulotaront, xanomeline/trospium chloride, vabicaserin, bitopertin, estradiol, cannabidiol, rimonabant, and D-serine showed efficacy for positive symptoms; roluperidone and pimavanserin were effective for negative symptoms; and encenicline, tropisetron, pregnenolone, tolcapone, BI 425809, and valacyclovir improved cognitive function. Discussion Compounds that function differently from existing antipsychotics may offer novel symptom-specific therapeutic strategies for patients with schizophrenia.

01 May 2024·The Journal of Pain

Alpha-7 Nicotinic Acetylcholine Receptor Activation Inhibits Trauma Induced Pronociceptive Autoimmune Responses

Article

Author: Guo, Tian-Zhi ; Wei, Tzuping ; Clark, John David ; Shi, Xiao-You ; Li, Wen-Wu ; Kingery, Wade S

Both autonomic nervous system dysfunction and immune system activation are characteristic of chronic pain after limb injuries. Cholinergic agonists reduce immune system activation in many settings. We hypothesized, therefore, that alpha-7 nicotinic acetylcholine receptor (α7nAChR) agonist administration would reduce nociceptive and immune changes after tibia fracture and cast immobilization in mice. Fracture mice were treated with either vehicle, a low (.2 mg/kg) dose, or a high (1 mg/kg) dose of the selective α7nAChR agonist PNU-282987 for 4 weeks. We assessed hindpaw allodynia and weight bearing as behavioral outcomes. The assessment of adaptive immune responses included regional lymph node hypertrophy, germinal center formation, α7nAChR expression, and IgM deposition. Assessment of innate immune system activation focused on IL-1β and IL-6 generation in fractured hindlimb skin. We observed that mechanical allodynia and unweighting were alleviated by PNU-282987 treatment. Drug treatment also reduced popliteal lymph node hypertrophy and germinal center formation. Immunohistochemical studies localized α7nAChR to germinal center B lymphocytes, and this expression increased after fracture. Analysis of fracture limb hindpaw skin demonstrated increased inflammatory mediator (IL-1β and IL-6) levels and IgM deposition, which were abrogated by PNU-282987. Serum analyses demonstrated fracture-induced IgM reactivity against keratin 16, histone 3.2, GFAP, and NMDAR-2B. Administration of PNU-282987 reduced the enhancement of IgM reactivity. Collectively, these data suggest that the α7nAChR is involved in regulating posttraumatic innate and adaptive immune responses and the associated nociceptive sensitization. PERSPECTIVE: These studies evaluate the effects of a selective α7nAChR agonist in a tibial fracture/cast immobilization model of limb pain. Administration of the drug reduced nociceptive and functional changes 4 weeks after injury. These novel findings suggest that well-tolerated α7nAChR agonists may be viable analgesics for chronic pain after limb injuries.

01 May 2024·Cell Chemical Biology

Transient hydroxycholesterol treatment restrains TCR signaling to promote long-term immunity

Article

Author: Zhu, Yiming ; Wang, Kun ; Li, Hua ; Zhang, Yong ; Wang, Haopeng ; Lou, Jizhong ; Ren, Zhengxu ; Xu, Chenqi ; Chen, Hui

T cell receptor (TCR) plays a fundamental role in adaptive immunity, and TCR-T cell therapy holds great promise for treating solid tumors and other diseases. However, there is a noticeable absence of chemical tools tuning TCR activity. In our study, we screened natural sterols for their regulatory effects on T cell function and identified 7-alpha-hydroxycholesterol (7a-HC) as a potent inhibitor of TCR signaling. Mechanistically, 7a-HC promoted membrane binding of CD3ε cytoplasmic domain, a crucial signaling component of the TCR-CD3 complex, through alterations in membrane physicochemical properties. Enhanced CD3ε membrane binding impeded the condensation between CD3ε and the key kinase Lck, thereby inhibiting Lck-mediated TCR phosphorylation. Transient treatments of TCR-T cells with 7a-HC resulted in reduced signaling strength, increased memory cell populations, and superior long-term antitumor functions. This study unveils a chemical regulation of TCR signaling, which can be exploited to enhance the long-term efficacy of TCR-T cell therapy.

News (Medical) associated with Encenicline Hydrochloride

08 Feb 2023

·www.biospace.com

Vanda Pharmaceuticals Reports Fourth Quarter and Full Year 2022 Financial Results

Q4 2022 total revenues were $64.5 million Full year 2022 revenues were $254.4 million Vanda provides update on pipeline advancements and upcoming milestones WASHINGTON, Feb. 8, 2023 /PRNewswire/ -- Vanda Pharmaceuticals, Inc. (Vanda) (Nasdaq: VNDA) today announced financial and operational results for the fourth quarter and full year ended December 31, 2022. "Our strong full year 2022 commercial performance positions Vanda well towards our objectives as we pursue a number of near term regulatory filings in bipolar I disorder, gastroparesis and insomnia," said Mihael H. Polymeropoulos, M.D., Vanda's President, CEO and Chairman of the Board. "At the same time, we continue to believe in the strength of our intellectual property portfolio as we proceed with our appeal in the HETLIOZ patent litigation." Financial Highlights Fourth Quarter of 2022 Total net product sales from HETLIOZ® and Fanapt® were $64.5 million in the fourth quarter of 2022, a 5% decrease compared to $68.0 million in the fourth quarter of 2021. HETLIOZ® net product sales were $40.1 million in the fourth quarter of 2022, a 9% decrease compared to $44.1 million in the fourth quarter of 2021, due in part to continued reimbursement challenges for prescriptions for patients with Non-24-Hour Sleep-Wake Disorder (Non-24). Fanapt® net product sales were $24.4 million in the fourth quarter of 2022, a 2% increase compared to $24.0 million in the fourth quarter of 2021. Net income was $6.9 million in the fourth quarter of 2022 compared to $7.1 million in the fourth quarter of 2021. Cash, cash equivalents and marketable securities (Cash) was $466.9 million as of December 31, 2022, representing an increase to Cash of $12.1 million, or 3%, compared to September 30, 2022. Full Year 2022 Total net product sales from HETLIOZ® and Fanapt® were $254.4 million for the full year 2022, a 5% decrease compared to $268.7 million for the full year 2021. HETLIOZ® net product sales were $159.7 million for the full year 2022, an 8% decrease compared to $173.5 million for the full year 2021, due in part to continued reimbursement challenges for prescriptions for patients with Non-24. Fanapt® net product sales were $94.7 million for the full year 2022, essentially flat compared to $95.1 million for the full year 2021. Net income was $6.3 million for the full year 2022 compared to net income of $33.2 million for the full year 2021. Cash, cash equivalents and marketable securities (Cash) was $466.9 million as of December 31, 2022, representing an increase to Cash of $34.0 million, or 8%, compared to December 31, 2021. Key Operational Highlights HETLIOZ® (tasimelteon) Vanda is continuing to pursue regulatory approvals for HETLIOZ® in the indications of insomnia and jet lag disorder. In December 2022, the U.S. District Court for the District of Delaware delivered its decision for the consolidated HETLIOZ® patent lawsuit against defendants Teva Pharmaceuticals USA, Inc. (Teva) and Apotex Inc. and Apotex Corp. (Apotex), ruling in favor of the defendants. Vanda filed an appeal to the U.S. Court of Appeals for the Federal Circuit where an oral argument is scheduled for March 14, 2023. Despite the pending appeal, Teva has launched at risk its generic version of HETLIOZ® in the U.S. In December 2022, Vanda filed patent infringement lawsuits against each of Teva and Apotex in the U.S. District Court for the District of New Jersey asserting that Teva and Apotex's generic versions of HETLIOZ® infringe U.S. Patent No. 11,285,129. Tradipitant Vanda is continuing to conduct an open-label safety study for tradipitant in gastroparesis and approximately the first 400 patients enrolled in the study were locked in preparation for the Company's planned New Drug Application (NDA) submission. The study continues to enroll open label patients and Vanda continues to receive requests from patients seeking access to tradipitant through the Expanded Access program, which has multiple patients who have taken tradipitant for more than one year. Vanda is preparing for the submission of an NDA for tradipitant for patients with gastroparesis. Vanda expects to submit this NDA to the FDA in the first half of 2023. The Phase III study of tradipitant in the treatment of motion sickness is over 75% enrolled. Results are expected by mid-2023. Fanapt® (iloperidone) In December 2022, Vanda announced positive results in the Phase III clinical study of Fanapt® in acute manic and mixed episodes associated with bipolar I disorder in adults. Vanda plans to submit a supplemental New Drug Application (sNDA) in the first half of 2023. Early-Stage Programs In December 2022, Vanda announced results in a Phase II clinical study of VQW-765 in the treatment of acute performance anxiety in social situations. This is the first time that an alpha 7 nicotinic acetylcholine receptor (α7-nAChR) partial agonist has shown efficacy in a clinical study of performance anxiety. GAAP Financial Results Net income was $6.9 million in the fourth quarter of 2022 compared to net income of $7.1 million in the fourth quarter of 2021. Diluted net income per share was $0.12 in the fourth quarter of 2022 compared to diluted net income per share of $0.12 in the fourth quarter of 2021. Net income was $6.3 million for the full year 2022 compared to net income of $33.2 million for the full year 2021. Diluted net income per share was $0.11 for the full year 2022 compared to diluted net income per share of $0.58 for the full year 2021. 2023 Financial Guidance Given uncertainties surrounding the U.S. market for HETLIOZ® for the treatment of Non-24 as a result of the ongoing HETLIOZ® patent litigation, Vanda is unable to provide 2023 financial guidance at this time. Vanda will continue to evaluate its ability to provide financial guidance as the year progresses. Conference Call Vanda has scheduled a conference call for today, Wednesday, February 8, 2023, at 4:30 PM ET. During the call, Vanda's management will discuss the fourth quarter and full year 2022 financial results and other corporate activities. Investors can call 1-800-715-9871 (domestic) or 1-646-307-1963 (international) and use passcode number 4734670. A replay of the call will be available on Wednesday, February 8, 2023, beginning at 8:30 PM ET and will be accessible until Wednesday, February 15, 2023 at 8:30 PM ET. The replay call-in number is 1-800-770-2030 for domestic callers and 1-609-800-9909 for international callers. The passcode number is 4734670. The conference call will be broadcast simultaneously on Vanda's website, . Investors should click on the Investors tab and are advised to go to the website at least 15 minutes early to register, download, and install any necessary software or presentations. The call will also be archived on Vanda's website for a period of 30 days. About Vanda Pharmaceuticals Inc. Vanda is a leading global biopharmaceutical company focused on the development and commercialization of innovative therapies to address high unmet medical needs and improve the lives of patients. For more on Vanda Pharmaceuticals Inc., please visit and follow us on Twitter @vandapharma. CAUTIONARY NOTE REGARDING FORWARD LOOKING STATEMENTS Various statements in this press release, including, but not limited to, statements regarding Vanda's plans for pursuit of regulatory approval of HETLIOZ® in the treatments of insomnia and jet lag disorder, tradipitant in the treatment of patients with gastroparesis and Fanapt® in the treatment of bipolar I in adults and the clinical development timeline for tradipitant in the treatment of motion sickness are "forward-looking statements" under the securities laws. All statements other than statements of historical fact are statements that could be deemed forward-looking statements. Forward-looking statements are based upon current expectations and assumptions that involve risks, changes in circumstances and uncertainties. Important factors that could cause actual results to differ materially from those reflected in Vanda's forward-looking statements include, among others, Vanda's ability to complete and submit the NDA for tradipitant and the sNDAs for HETLIOZ® and Fanapt® in the specified timeframes, the FDA's assessment of the sufficiency of the data packages to be included in Vanda's planned NDA submission for tradipitant and sNDA submissions for HETLIOZ® and Fanapt®, and Vanda's ability to complete the Phase III clinical study of tradipitant in the treatment of motion sickness by mid-2023. Therefore, no assurance can be given that the results or developments anticipated by Vanda will be realized or, even if substantially realized, that they will have the expected consequences to, or effects on, Vanda. Forward-looking statements in this press release should be evaluated together with the various risks and uncertainties that affect Vanda's business and market, particularly those identified in the "Cautionary Note Regarding Forward-Looking Statements", "Risk Factors" and "Management's Discussion and Analysis of Financial Condition and Results of Operations" sections of Vanda's most recent Annual Report on Form 10-K, as updated by Vanda's subsequent Quarterly Reports on Form 10-Q, Current Reports on Form 8-K and other filings with the U.S. Securities and Exchange Commission, which are available at . All written and verbal forward-looking statements attributable to Vanda or any person acting on its behalf are expressly qualified in their entirety by the cautionary statements contained or referred to herein. Vanda cautions investors not to rely too heavily on the forward-looking statements Vanda makes or that are made on its behalf. The information in this press release is provided only as of the date of this press release, and Vanda undertakes no obligation, and specifically declines any obligation, to update or revise publicly any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law. Corporate Contact: Kevin Moran Senior Vice President, Chief Financial Officer and Treasurer Vanda Pharmaceuticals Inc. 202-734-3400 pr@vandapharma.com Elizabeth Van Every Head of Corporate Affairs Vanda Pharmaceuticals Inc. 202-734-3400 pr@vandapharma.com Company Codes: NASDAQ-NMS:VNDA

Financial StatementPhase 3NDAPhase 2

02 Dec 2022

·www.prnewswire.com

Vanda Pharmaceuticals Reports Results in a Phase II Clinical Study of VQW-765 in the Treatment of Acute Performance Anxiety

WASHINGTON, Dec. 2, 2022 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) today reported results in a Phase II clinical study of VQW-765, a novel small molecule alpha 7 nicotinic acetylcholine receptor (α7-nAChR) partial agonist, in the treatment of acute performance anxiety in social situations, such as public speaking. In clinical study VP-VQW-765-2201 (Study 2201), 230 volunteers with prior history of performance anxiety were randomized to receive a single dose of VQW-765 or placebo and were challenged with the standardized Trier Social Stress Test (TSST). The TSST creates an acute stress by requiring participants to make an interview-style presentation in front of a panel who provides no feedback or encouragement. Participants who received VQW-765 showed numerically lower stress levels compared to those who received placebo. In Study 2201, the stress level was assessed by the Subjective Units of Distress Scale (SUDS), a self-rating scale of level of nervousness or distress ranging from 0 to 100 at multiple timepoints during the duration of the TSST. In particular, female participants (approximately 70% of the total participants) reported a larger magnitude and statistically significant response to VQW-765. A higher stress reaction in females (as well as higher prevalence of performance anxiety) as compared to male participants is consistent with prior reports in this particular test of acute performance anxiety.1 A significant relationship was also seen between exposure to VQW-765 (amount of drug measured in blood) and the clinical response. This is the first time that an alpha 7 nicotinic acetylcholine receptor (α7-nAChR) partial agonist has shown efficacy in a clinical study of performance anxiety. The observed significant relationship between exposure and clinical outcome further supports the hypothesis that VQW-765 could be effective in treating performance anxiety and creates a valuable roadmap to future confirmatory studies. Clinical data gathered indicates an adverse event profile similar to placebo and there were no observed negative cognitive effects reported by any participant in Study 2201. If the results of the current study are confirmed, VQW-765 could be the first drug in the class of nicotinic receptor agonists approved to treat performance anxiety. About VQW-765 VQW-765 is a novel small molecule alpha 7 nicotinic acetylcholine receptor (α7-nAChR) partial agonist, with potential use for the treatment of psychiatric disorders. VQW-765 binds and enhances the activity of one type of nicotinic receptors composed of a pentameric assembly of the alpha 7 subtype. While nicotine can also bind this receptor, the binding affinity of VQW-765 is much higher than nicotine itself making it a potent and specific molecule for the alpha 7 receptor. VQW-765, formerly known as AQW-051, was licensed to Vanda from Novartis. About Performance Anxiety An estimated over 20% of the U.S. population experiences debilitating performance anxiety that ranges from public speaking to test taking, writer's block and musical performance.2, 3 The most common type of performance anxiety is public speaking anxiety. People with performance anxiety report that the condition can hinder or even threaten their professional career of choice. Similarly, musicians report that performance anxiety makes them perform at levels below their capabilities. Currently, there is no FDA-approved drug treatment available for performance anxiety and general anti-anxiolytic drugs tend to be sedating which is not preferred in a performance situation. References Santl, J., Shiban, Y., Plab, A., Wüst, S., Kudielka, B. M., & Mühlberger, A. (2019). Gender Differences in Stress Responses during a Virtual Reality Trier Social Stress Test. International Journal of Virtual Reality, 19(2). Stein, M. B., Walker, J. R., & Forde, D. R. (1996). Public-Speaking Fears in a Community Sample. Prevalence, Impact on Functioning, and Diagnostic Classification. Archives of general psychiatry, 53(2), 169–174. Ebrahimi, O. V., Pallesen, S., Kenter, R. M., & Nordgreen, T. (2019). Psychological Interventions for the Fear of Public Speaking: A Meta-Analysis. Frontiers in Psychology, 10. About Vanda Pharmaceuticals Inc. Vanda is a leading global biopharmaceutical company focused on the development and commercialization of innovative therapies to address high unmet medical needs and improve the lives of patients. For more on Vanda Pharmaceuticals Inc., please visit and follow us on Twitter @vandapharma. CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS Various statements in this press release, including, but not limited to statements regarding Vanda's clinical development plan and strategies for VQW-765 and the safety and efficacy of VQW-765, are "forward-looking statements" under the securities laws. Forward-looking statements are based upon current expectations that involve risks, changes in circumstances, assumptions and uncertainties. Important factors that could cause actual results to differ materially from those reflected in Vanda's forward-looking statements include, among others, the ability of VQW-765 to safely and effectively treat performance anxiety and Vanda's ability to complete the clinical development of, and obtain regulatory approval for, VQW-765. There can be no assurance that the actual results or developments anticipated by Vanda will be realized or, even if substantially realized, that they will have the expected consequences to, or effects on, Vanda. Therefore, no assurance can be given that the outcomes stated in such forward-looking statements and estimates will be achieved. Forward-looking statements in this press release should be evaluated together with the various risks and uncertainties that affect Vanda's business and market, particularly those identified in the "Cautionary Note Regarding Forward-Looking Statements", "Risk Factors" and "Management's Discussion and Analysis of Financial Condition and Results of Operations" sections of Vanda's Annual Report on Form 10-K for the fiscal year ended December 31, 2021, as updated by Vanda's subsequent Quarterly Reports on Form 10-Q, Current Reports on Form 8-K and other filings with the U.S. Securities and Exchange Commission, which are available at . All written and verbal forward-looking statements attributable to Vanda or any person acting on its behalf are expressly qualified in their entirety by the cautionary statements contained or referred to herein. Vanda cautions investors not to rely too heavily on the forward-looking statements Vanda makes or that are made on its behalf. The information in this press release is provided only as of the date of this press release, and Vanda undertakes no obligation, and specifically declines any obligation, to update or revise publicly any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law. Corporate Contact: Kevin Moran Senior Vice President, Chief Financial Officer and Treasurer Vanda Pharmaceuticals Inc. 202-734-3400 [email protected] Elizabeth Van Every Head of Corporate Affairs Vanda Pharmaceuticals Inc. 202-734-3400 [email protected] SOURCE Vanda Pharmaceuticals Inc.

Clinical ResultPhase 2

11 May 2010

·www.biospace.com

EnVivo Pharmaceuticals, Inc. Initiates Phase IIb Alzheimer's Disease Trial For EVP-6124

WATERTOWN, Mass., May 11 /PRNewswire/ -- EnVivo Pharmaceuticals today announced the initiation and dosing of patients in a Phase IIb study of its EVP-6124 compound, a selective alpha-7 nicotinic agonist in patients with mild to moderate Alzheimer's disease. The multi-center, dose ranging, placebo controlled, six-month study taking place in the U.S. and Europe is designed to determine the safety and efficacy of EVP-6124 in producing procognitive effects and improving the clinical condition of Alzheimer's disease patients. "Patients with Alzheimer's disease have a number of symptomatic therapies available to them. However, the effects of the available medications are modest. Even if significant progress is made in slowing disease progression, more effective therapies that sustainably improve the cognition of the patients are clearly needed," said Kees Been, EnVivo president and CEO. "There is growing consensus that alpha-7 nicotinic agonists can potentially improve the cognitive function in Alzheimer's disease patients as evidenced by the number of large pharmaceutical companies advancing similar drugs through development. The potential upside for patients is considerable and we look forward to completing our Alzheimer's disease study by the middle of next year." The Phase IIb study will enroll mild to moderate Alzheimer's disease patients who will be randomized to three separate doses of EVP-6124 or placebo over six months. Efficacy will primarily be determined by the ADAS-Cog scale, a commonly used and accepted measure of cognition in patients with Alzheimer's disease. Secondary assessments will include other cognitive and clinical measures. EVP-6124 also is being tested in patients with schizophrenia in a separate Phase IIb study that started in late 2009. Two previous studies with EVP-6124 in Alzheimer's disease patients demonstrated that it was well tolerated and produced significant effects on a variety of cognitive measures of brain function such as attention, memory and executive function (complex thinking tasks). EVP-6124 had procognitive effects in two separate clinical trials: one study conducted in Alzheimer's disease patients already treated with Acetyl Choline Esterase Inhibitors (AChEI) and one in Alzheimer's disease patients not on AChEI therapy (naive patients). EVP-6124 is a selective agonist for the alpha-7 subtype of the nicotinic acetylcholine receptor and is being developed by EnVivo for potential cognitive enhancement in both schizophrenia and Alzheimer's patients. It has been shown to have excellent CNS penetration, oral bioavailability, pharmacokinetics and metabolic profile. About EnVivo Pharmaceuticals EnVivo Pharmaceuticals, located in Watertown, Mass., is a biopharmaceutical company dedicated to discovering and developing small molecule therapeutics for disorders of the central nervous system, with a current focus on Alzheimer's disease, cognitive disorders and schizophrenia. The company's lead product is an alpha-7 nicotinic acetylcholine receptor agonist and has been tested in Phase IIa clinical trials for cognition disorders in Alzheimer's disease and schizophrenia. The company's other programs include an epigenetics program based on Histone Deacetylase inhibition (HDACi) with EVP-0334 as the lead molecule for cognition in Alzheimer's disease which has completed Phase I studies, and several preclinical programs such as a Gamma Secretase Modulator (for Alzheimer's disease) and a PDE10 inhibitor program (for schizophrenia). For more information about EnVivo, visit . SOURCE EnVivo Pharmaceuticals

Small molecular drug

100 Deals associated with Encenicline Hydrochloride

External Link

KEGG	Wiki	ATC	Drug Bank
D10702	Encenicline Hydrochloride	-	DB11726

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Cognitive Dysfunction	Phase 3	SG	FORUM Pharmaceuticals, Inc.	01 Oct 2012
Cognitive Dysfunction	Phase 3	PL	FORUM Pharmaceuticals, Inc.	01 Oct 2012
Cognitive Dysfunction	Phase 3	MX	FORUM Pharmaceuticals, Inc.	01 Oct 2012
Cognitive Dysfunction	Phase 3	IT	FORUM Pharmaceuticals, Inc.	01 Oct 2012
Cognitive Dysfunction	Phase 3	GB	FORUM Pharmaceuticals, Inc.	01 Oct 2012
Cognitive Dysfunction	Phase 3	RS	FORUM Pharmaceuticals, Inc.	01 Oct 2012
Cognitive Dysfunction	Phase 3	UA	FORUM Pharmaceuticals, Inc.	01 Oct 2012
Cognitive Dysfunction	Phase 3	RU	FORUM Pharmaceuticals, Inc.	01 Oct 2012
Cognitive Dysfunction	Phase 3	US	FORUM Pharmaceuticals, Inc.	01 Oct 2012
Cognitive Dysfunction	Phase 3	AU	FORUM Pharmaceuticals, Inc.	01 Oct 2012

Clinical Result

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT01480232 (CTgov)	Phase 2	Smoking Cessation \| Nicotine Dependence	345	Brief Supportive+EVP-6124 (EVP-6124 + NRT Patch (Placebo))	abejrndnlp(khjjimvpgv) = svxgsfkluu ftmwdegwfv (atlmnqbzyt, ftatasimrx - mxfowqyasy) View more	-	06 Apr 2017
				Brief Supportive (Placebo + NRT Patch (Placebo))	abejrndnlp(khjjimvpgv) = lrkkgarupo ftmwdegwfv (atlmnqbzyt, vuballwgnm - qhjvxzrnkv) View more
P7.100 (AAN2015)	Phase 2	Alzheimer Disease Add-on	409	Encenicline 0.27mg	(imokaipfag) = ehzcyuhkdm ohspkhytme (mgatwxyxuw )	Positive	06 Apr 2015
				Encenicline 0.9mg	(imokaipfag) = zqpzrhztmq ohspkhytme (mgatwxyxuw )
NCT01556763 (CTgov)	Phase 1	Central Nervous System Diseases \| Schizoaffective disorder \| Schizophrenia	21	Placebo+Antipsychotic therapy (Placebo)	pzhkabyhfd(natancklkz) = mgwtjjockl yyvzuccjcb (ibsrmqjkur, usxjgfzzup - pzldxbcfly) View more	-	21 Jun 2012
				EVP-6124 (1.0 mg/day)+Antipsychotic therapy (EVP-6124 (1.0 mg/Day))	pzhkabyhfd(natancklkz) = pnudscgtwc yyvzuccjcb (ibsrmqjkur, lumsateyhx - bmxvrejwaa) View more
NCT00766363 (CTgov)	Phase 1	Alzheimer Disease	49	EVP-6124 (0.1 mg/day)+Rivastigmine+Donepezil (EVP-6124 (0.1 mg/Day))	(wokewxurcx) = pynpcroxmq loqbinjeag (thuomyccai, nymfijejui - ckkvlsymuf) View more	-	14 Jul 2011
				EVP-6124 (0.3 mg/day)+Rivastigmine+Donepezil (EVP-6124 (0.3 mg/Day))	(wokewxurcx) = lrmjboxiai loqbinjeag (thuomyccai, bnakstbrlx - ohlxmtcsaa) View more

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