Product Type

Category

No. of news

Page

Frequent abbreviations

Pharmaceuticals

Small molecule

36

3

Ol

Open-label

Antibody

5

9

Rx

Randomized

Protein

6

10

Db

Double-blind

Peptide

5

11

Pc

Placebo-controlled

RNA

5

12

Pts

Patients

DNA

2

13

PK

Pharmacokinetic

Cells

5

14

PD

Pharmacodynamic

Vaccine

5

15

PoC

Proof-of-concept

Natural Source

3

16

NCE

New chemical entity

Generics

5

17

Co

Cross-over

Drug Delivery 

8

18

GRAS

Generally recognized as safe

Radiotherapy & Radiopharmaceuticals 

2

19

NDI

New dietary ingredient

NutraCeuticals, Dietary Supplements & Cosmeceuticals 

-

-

ANDA

Abbreviated new drug application

Biomaterials, Medical Devices, Combination & NanoTechnology Products 

7

20

BLA

Biologics License Application

Company Profiles 

-

IDE

Investigational device exemption

Technology & BioManufacturing Sites 

6

21

NDA

New drug application

R&D Collaborations

6

22

MAA

Marketing authorization application

R&D Licensing Agreements 

7

23

SPA

Special protocol assessment

Product Type:  Pharmaceutical

Category:  Small molecule

ID No.

Product Name

Target / Mechanism of Action

Class of Compound

Company

Therapeutic Area

Indication

R&D Stage

Message

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