LY353381 — Competitive Intelligence Brief

LY353381 (LY353381) competitive landscape: 6 comparators, recent regulatory actions, upcoming PDUFA, patent timeline. Class: Selective Estrogen Receptor Modulator (SERM). Area: Cardiovascular, Bone Health, Women's Health.

phase 3 Selective Estrogen Receptor Modulator (SERM) Estrogen receptor alpha (ERα) and estrogen receptor beta (ERβ) Cardiovascular, Bone Health, Women's Health Small molecule

Target snapshot

LY353381 (LY353381) — Eli Lilly and Company. LY353381 is a selective estrogen receptor modulator (SERM) that acts as a partial agonist at estrogen receptors to provide bone-protective and cardiovascular benefits without stimulating breast or endometrial tissue.

Comparator set (6 drugs)

Drug	Generic	Sponsor	Phase	Class	Target	Approval / PDUFA
LY353381 TARGET	LY353381	Eli Lilly and Company	phase 3	Selective Estrogen Receptor Modulator (SERM)	Estrogen receptor alpha (ERα) and estrogen receptor beta (ERβ)
fenofibrate and tibolone	fenofibrate and tibolone	Keogh Institute for Medical Research	marketed	Fibrate + Selective Estrogen Receptor Modulator (SERM)	PPAR-α (fenofibrate); Estrogen receptor, progesterone receptor, androgen receptor (tibolone)
E2Nomac	E2Nomac	Sydney Centre for Reproductive Health Research	marketed	Selective Estrogen Receptor Modulator (SERM)	Estrogen receptor (ER-α/ER-β)
Low-dose Clomiphene	Low-dose Clomiphene	Weill Medical College of Cornell University	marketed	Selective estrogen receptor modulator (SERM)	Estrogen receptor (ER-α and ER-β)
raloxifene HCI and alendronate Na	raloxifene HCI and alendronate Na	Eli Lilly and Company	marketed	Selective estrogen receptor modulator (SERM) + bisphosphonate combination	Estrogen receptor (raloxifene); osteoclast farnesyl pyrophosphate synthase (alendronate)
teriparatide and raloxifene	teriparatide and raloxifene	Medical University of Vienna	marketed	Combination therapy: PTH analog and selective estrogen receptor modulator (SERM)	PTH1 receptor (teriparatide); estrogen receptor alpha and beta (raloxifene)
Toremifene; Anastrozole	Toremifene; Anastrozole	Peking Union Medical College Hospital	marketed	Selective estrogen receptor modulator (SERM) + aromatase inhibitor (AI)	Estrogen receptor (ER); aromatase (CYP19A1)

Recent regulatory actions (last 90 days)

No regulatory actions in the last 90 days for this set.

Upcoming PDUFA dates (next 180 days)

No PDUFA dates in the next 180 days for this set.

Patent timeline (forward window)

No upcoming patent expiries for this set.

Sponsor landscape (Selective Estrogen Receptor Modulator (SERM) class)

1. Eli Lilly and Company · 1 drug in this class
2. Sebela Women's Health Inc. · 1 drug in this class
3. Sydney Centre for Reproductive Health Research · 1 drug in this class
4. Wyeth is now a wholly owned subsidiary of Pfizer · 1 drug in this class