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Product Type:
Pharmaceutical |
Category:
Small
molecule
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ID No. |
Product Name |
Target / Mechanism of
Action |
Class
of Compound |
Company |
Therapeutic
Area |
Indication |
R&D Stage |
Message |
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S
333 |
Aliskiren;
SPP100 |
Renin inhibition |
Oral small molecule |
Novartis & Speedel |
Cardio-vascular & renal |
Hypertension: monotherapy;
combination |
III
II |
Released positive phase
III results from monotherapy and HCTZ-combination studies and plan filing
in 2006 HTUread
moreUTH |
|
S
346 |
MC-1 |
Purinergic receptor agonist |
Naturally occurring small molecule |
Medicure |
Cardio-vascular |
Prevention of cardio- + cerebrovascular events after PCI, CABG and ACS |
II/III |
FDA granted Fast Track
Designation HTUread
moreUTH |
|
S
046 |
ISA247 |
Immuno-suppressive |
Trans-isomer of cyclospo-rine analog |
Isotechnika |
Dermatology |
Stable moderate to severe psoriasis |
III |
Announced that phase
III study met all primary and secondary endpoints
HTUread
moreUTH |
|
S
348 |
Aplaviroc;
GW873140; ONO-4128 |
CCR5 chemokine antagonism |
Oral small molecule |
GSK |
Infectious |
Treatment naive HIV
Treatment experienced HIV |
II
III |
GSK halted all clinical
trials with the CCR5 inhibitor after two pts developed severe liver
toxicity in the phase II study
HTUread
moreUTH |
|
S
343 |
Vildagliptin
LAF237 |
DPP-IV inhibition |
Oral small molecule |
Novartis |
Metabolism & endocrine |
Type 2 diabetes |
III |
New study results show
sustained efficacy (after 12 wks) in lowering HbA1c and excellent
tolerability without weight gain; plans to file in 2006
HTUread
moreUTH |
|
S
331 |
Parecoxib |
COX-2 selective antagonism |
Non-narcotic injectable small molecule |
Pfizer |
Neurology & psychiatry & pain |
Acute pain in post-surgical setting |
NDA |
Received non-approvable
letter from FDA for parecoxib which is approved in many countries and
marketed in the EU as Dynastat
HTUread
moreUTH |
|
S
191 |
Neurodex;
AVP 923 |
NMDA R
antagonism + sigma-1 agonism |
Combination of dextro-methorphan + quinidine sulfate |
Avanir |
Neurology & psychiatry |
Pseudobulbar affect |
NDA |
FDA requested more
analyses to better support the electronic data submission guideline
HTUread
moreUTH |
|
S
010 |
Phenserine tartrate |
Acetycholin-esterase synthesis of beta-amyloid |
Small molecule |
Axonyx |
Neurology & psychiatry |
Mild to moderate Alzheimer’s disease |
III |
12-wk treatment did not
achieve significant improvement over placebo as measured by scales
HTUread
moreUTH
|
|
S
335 |
Silenor™
Doxepin hydro-chloride |
Presumably via influence on adrenergic activity |
Oral small molecule (tricyclic compound) |
Somaxon Pharma-ceuticals |
Neurology & psychiatry |
Sleep maintenance insomnia |
III |
Announced that
enrollment has begun in the second phase III trial with 3-mth dosing
HTUread
moreUTH |
|
S
351 |
ACP-104 |
Partial ago-nism of D2 + D3 dopamine R, muscarinic M1 agonism, 5-HT2A
inver-se agoninsm |
Small molecule (major metabolite of clozapine) |
Acadia Pharma-ceuticals |
Neurology & psychiatry |
Schizophrenia |
II |
Published results of
preclinical investigation in the JPET about molecular mechanisms of new
schizophrenia drug candidate
HTUread
moreUTH |
|
S
080 |
arimoclomol |
Induces heat shock protein expression |
Oral small molecule: L-hydroxylamine derivative |
CytRx |
Neurology & psychiatry |
Amyotrophic lateral sclerosis (Lou-Gehrig’s diseaes) |
II |
Initiated phase II
study which plans to enroll n=80 pts in the db, pc study in the US to
evaluate safety and tolerability
HTUread
moreUTH |
|
S
352 |
NG2-73 |
GABA-A receptor modulation |
Oral small molecule |
Neurogen |
Neurology & psychiatry |
Insomnia |
I |
Induction of deep sleep
was “dose-limiting” effect in phase I trial with healthy volunteers,
single doess of drug were well tolerated
HTUread
moreUTH |
|
S
034 |
Flurizan; MCP-7869 |
Selective amyloid beta lowering (Abeta42 inhibition) |
Oral small molecule (R-enantiomer of flurbiprofen) |
Myriad Genetics |
Neurology & psychiatry |
Mild Alzheimer’s disease |
III |
Follow-on study results
suggest that pts appear to stabilize from months 12 to 15 with continued
medication HTUread
moreUTH |
|
S
116 |
Taxotere®
docetaxel |
Tubulin |
Semisyn-thetic small molecule |
Sanofi-Aventis |
Oncology |
Various cancers
Early stage Her2+ breast cancer |
Mar-ket
III |
Interim results of
phase III study of taxotere-including chemotherapy plus trastuzumab show
significantly improved disease free survival
HTUread
moreUTH |
|
S
296 |
Xinlay™ atrasentan |
Selective endothelin A receptor antagonism |
Oral small molecule |
Abbott |
Oncology |
Hormone-refractory prostate cancer with bone metastases |
NDA |
HTUread
briefing docsUTH
FDA Advisory Committee
did not recommend the drug for approval, phase III study with earlier
stage HRPC is ongoing
HTUread
moreUTH |
|
S
285 |
Sorafenib; BAY43-9006 |
Multi-kinase: RAF, VEGF-R2, VEGF-R3, KIT, FLT-3, RET |
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